Cystitis, Interstitial
Conditions
Keywords
Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety
Brief summary
In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels
Detailed description
This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.
Interventions
BIOLOGICALTanezumab
1 mg dose given subcutaneously twice at an 8-week interval.
OTHERPlacebo
Placebo dose given subcutaneously twice at an 8-week interval.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day. * Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.
Exclusion criteria
* Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome. * Body mass index (BMI) of \>39 kg/m2. * History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein. * Patients with peripheral neuropathy. * Patients with Type I or type II diabetes mellitus who have an HbA1c \> 8.0%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Average Daily Pain Score at Week 8 | Baseline, Week 8 | Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Micturitions Per 24 Hours | Baseline, Week 4, 8, 12, 16, 20, 24 | The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected. |
| Mean Voided Volume Per Micturition | Baseline, Week 4, 8, 12, 16, 20, 24 | Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day. |
| O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline, Week 2, 8, 16, 24 | The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother. |
| Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline, Week 8, 16, 24 | BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference. |
| Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8, 16, 24 | Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: Overall, how satisfied are you with the drug that you received since you entered this trial? Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported. |
| Number of Participants With Patient Global Preference Assessment Score | Week 8, 16, 24 | Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category. |
| Number of Participants With Willingness to Re-use Medicine Assessment | Week 8, 16, 24 | Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis? Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want). |
| Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Baseline, Week 8, 16, 24 | EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Baseline, Week 2, 8, 16, 24 | PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life. |
| Percentage of Participants Who Received Rescue Medication | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication. |
| Number of Days of Rescue Medication Usage Per Week | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication. |
| Number of Rescue Medication Doses Used Per Week | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication. |
| Amount of Rescue Medication Taken Per Week | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication. |
| Serum Total Nerve Growth Factor (NGF) Levels | Baseline, Week 1, 2, 8, 16, 24 | Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method. |
| Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain. |
| Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8, 16 | Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain. |
| Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain. |
| Patient Global Assessment of Health Status Scores | Baseline, Week 2, 8, 16, 24 | Participants answered: Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today? Participants responded on a 5-point scale where 1 = very good and 5 = very poor. |
| Number of Participants With Global Response Assessment Scores | Week 8, 16, 24 | Participants were asked: compared to when you began this trial, how would you rate your IC/PBS symptoms now? Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved. |
| Number of Nocturnal Micturitions Per 24 Hours | Baseline, Week 4, 8, 12, 16, 20, 24 | The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected. |
| Number of Micturition-related Urgency Episodes Per 24 Hours | Baseline, Week 4, 8, 12, 16, 20, 24 | The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded. |
| Participant's Urge to Urinate | Baseline, Week 4, 8, 12, 16, 20, 24 | Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body Temperature | Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24 | — |
| Systolic and Diastolic Blood Pressure | Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24 | Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. |
| Heart Rate | Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24 | — |
| Respiratory Rate | Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24 | — |
| Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening, Day 1, Week 2, 8, 16, 24 | Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB). |
| Electrocardiogram Parameter: Heart Rate | Screening, Day 1, Week 2, 8, 16, 24 | — |
| Post-void Residual (PVR) Volume | Screening, Week 2, 8, 16, 24 | PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination. |
| Number of Participants With Urinalysis Abnormalities | Screening up to Week 24 | Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (\<1.003 and \>1.030), urine pH (\<4.5 and \>8), protein (\>=1 value in qualitative test), glucose (\>=1 value in qualitative test), ketones (\>=1 value in qualitative test), blood (\>=1 value in qualitative test), bilirubin (\>=1 value in qualitative test), nitrites (\>=1), and leukocyte esterase (\>=1) are reported. |
| Number of Participants With Laboratory Test Abnormalities | Screening up to Week 24 | Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline up to 112 days after the last dose (up to Week 24) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. |
| Number of Participants With Anti-Drug Antibody (ADA) | Baseline, Week 8, 16, 24 | Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Baseline, Week 2, 8, 16, 24 | The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment. |
| Number of Participants With Neurological Examination Findings | Week 2, 8, 16, Week 24 or early termination | A neurological examination assessed the 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 fingers and great toes. |
Countries
Belgium, Canada, Finland, Hong Kong, Japan, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | 42 |
| Tanezumab 1 mg Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | 41 |
| Tanezumab 2.5 mg Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | 37 |
| Tanezumab 10 mg Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | 40 |
| Tanezumab 20 mg Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24. | 40 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 | 3 | 1 | 2 |
| Overall Study | Did not meet entrance criteria | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 2 | 0 | 0 | 2 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 4 | 1 |
| Overall Study | Other | 5 | 7 | 1 | 4 | 5 |
| Overall Study | Pregnancy | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Randomized but not Treated | 1 | 1 | 2 | 0 | 1 |
| Overall Study | Study terminated by sponsor | 10 | 6 | 5 | 5 | 9 |
| Overall Study | Withdrawal by Subject | 5 | 4 | 10 | 6 | 1 |
Baseline characteristics
| Characteristic | Placebo | Tanezumab 1 mg | Tanezumab 2.5 mg | Tanezumab 10 mg | Tanezumab 20 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 13.5 | 45.2 years STANDARD_DEVIATION 14.9 | 47.2 years STANDARD_DEVIATION 13.1 | 51.3 years STANDARD_DEVIATION 14.5 | 45.3 years STANDARD_DEVIATION 14.2 | 48.1 years STANDARD_DEVIATION 14.2 |
| Sex: Female, Male Female | 38 Participants | 33 Participants | 31 Participants | 36 Participants | 32 Participants | 170 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 6 Participants | 4 Participants | 8 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 42 | 25 / 41 | 15 / 37 | 27 / 40 | 22 / 40 |
| serious Total, serious adverse events | 0 / 42 | 4 / 41 | 6 / 37 | 1 / 40 | 1 / 40 |
Outcome results
Primary
Change From Baseline in Mean Average Daily Pain Score at Week 8
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time frame: Baseline, Week 8
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Baseline | 5.38 units on a scale | Standard Deviation 1.259 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Change at Week 8 | -1.21 units on a scale | Standard Deviation 1.682 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Baseline | 5.72 units on a scale | Standard Deviation 1.337 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Change at Week 8 | -1.16 units on a scale | Standard Deviation 1.76 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Baseline | 6.01 units on a scale | Standard Deviation 1.381 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Change at Week 8 | -1.49 units on a scale | Standard Deviation 2.502 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Change at Week 8 | -1.60 units on a scale | Standard Deviation 2.175 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Baseline | 5.76 units on a scale | Standard Deviation 1.669 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Baseline | 6.08 units on a scale | Standard Deviation 1.288 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 8 | Change at Week 8 | -1.57 units on a scale | Standard Deviation 1.61 |
Comparison: The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).95% CI: [-0.4, 0.35]
Comparison: The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.95% CI: [-0.8, 0.68]
Comparison: The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.95% CI: [-1.15, 0.83]
Comparison: The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.95% CI: [-0.93, 0.47]
Secondary
Amount of Rescue Medication Taken Per Week
In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Amount of Rescue Medication Taken Per Week | Baseline | 5827.3 mg/week | Standard Deviation 4485.87 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 1 | 5527.8 mg/week | Standard Deviation 3908.78 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 2 | 4333.3 mg/week | Standard Deviation 4749.56 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 21 | 6333.3 mg/week | Standard Deviation 4792.36 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 22 | 5625.0 mg/week | Standard Deviation 3482.1 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 3 | 4573.3 mg/week | Standard Deviation 4831.66 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 4 | 4371.4 mg/week | Standard Deviation 4431.6 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 5 | 4342.9 mg/week | Standard Deviation 4300.22 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 23 | 8375.0 mg/week | Standard Deviation 5566.16 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 24 | 7500.0 mg/week | Standard Deviation 4560.7 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 6 | 4873.3 mg/week | Standard Deviation 4005.08 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 7 | 5181.3 mg/week | Standard Deviation 4803.36 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 8 | 4740.0 mg/week | Standard Deviation 2844.74 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 9 | 5238.5 mg/week | Standard Deviation 2722.91 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 10 | 4266.7 mg/week | Standard Deviation 3272.54 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 11 | 5538.5 mg/week | Standard Deviation 3078.57 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 12 | 4954.5 mg/week | Standard Deviation 3791.14 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 13 | 6500.0 mg/week | Standard Deviation 8638.58 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 14 | 6269.2 mg/week | Standard Deviation 5666.48 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 15 | 5083.3 mg/week | Standard Deviation 4655.56 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 16 | 5375.0 mg/week | Standard Deviation 4332.19 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 17 | 6000.0 mg/week | Standard Deviation 5454.36 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 18 | 6437.5 mg/week | Standard Deviation 6038.2 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 19 | 6500.0 mg/week | Standard Deviation 4242.64 |
| Placebo | Amount of Rescue Medication Taken Per Week | Week 20 | 7333.3 mg/week | Standard Deviation 4191.26 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 4 | 4013.6 mg/week | Standard Deviation 4024.84 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 2 | 4590.9 mg/week | Standard Deviation 4052.15 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 20 | 3300.0 mg/week | Standard Deviation 3290.14 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 6 | 3320.0 mg/week | Standard Deviation 2758.83 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 13 | 5800.0 mg/week | Standard Deviation 4211.1 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 11 | 5681.8 mg/week | Standard Deviation 5316.36 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 15 | 8214.3 mg/week | Standard Deviation 8489.49 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 1 | 5090.9 mg/week | Standard Deviation 4055.09 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 7 | 6181.8 mg/week | Standard Deviation 3363.57 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 19 | 4250.0 mg/week | Standard Deviation 4157.61 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 12 | 6250.0 mg/week | Standard Deviation 5731.25 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 21 | 3600.0 mg/week | Standard Deviation 3595.14 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 17 | 3571.4 mg/week | Standard Deviation 3207.13 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 8 | 6071.4 mg/week | Standard Deviation 4367.08 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 24 | 3166.7 mg/week | Standard Deviation 2020.73 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 23 | 3300.0 mg/week | Standard Deviation 2841.65 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Baseline | 4781.5 mg/week | Standard Deviation 4596.49 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 18 | 3285.7 mg/week | Standard Deviation 2766.72 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 9 | 6884.6 mg/week | Standard Deviation 5838.64 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 22 | 2750.0 mg/week | Standard Deviation 2715.7 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 5 | 5625.0 mg/week | Standard Deviation 4368.45 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 16 | 6083.3 mg/week | Standard Deviation 3292.67 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 14 | 5250.0 mg/week | Standard Deviation 4184.96 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 10 | 4785.7 mg/week | Standard Deviation 4259.44 |
| Tanezumab 1 mg | Amount of Rescue Medication Taken Per Week | Week 3 | 4190.5 mg/week | Standard Deviation 3838.87 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 10 | 7181.8 mg/week | Standard Deviation 5934.11 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 2 | 5300.0 mg/week | Standard Deviation 5795.64 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 11 | 5500.0 mg/week | Standard Deviation 4398.86 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 19 | 6400.0 mg/week | Standard Deviation 5042.32 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 14 | 5562.5 mg/week | Standard Deviation 3310.56 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 12 | 6333.3 mg/week | Standard Deviation 3848.7 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 13 | 6777.8 mg/week | Standard Deviation 5810.07 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 23 | 4500.0 mg/week | Standard Deviation 2886.75 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 22 | 5375.0 mg/week | Standard Deviation 4534.59 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 17 | 6000.0 mg/week | Standard Deviation 4133.2 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 24 | 6000.0 mg/week | Standard Deviation 2121.32 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 5 | 5866.7 mg/week | Standard Deviation 5569.26 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 4 | 4312.5 mg/week | Standard Deviation 4003.64 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 6 | 5178.6 mg/week | Standard Deviation 4846.12 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 3 | 5861.1 mg/week | Standard Deviation 5232.27 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 1 | 5444.4 mg/week | Standard Deviation 6125.86 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 7 | 5392.9 mg/week | Standard Deviation 4637.55 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 16 | 5500.0 mg/week | Standard Deviation 3807.89 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Baseline | 5428.6 mg/week | Standard Deviation 4688.51 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 20 | 5375.0 mg/week | Standard Deviation 4413.86 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 8 | 6307.7 mg/week | Standard Deviation 6223.4 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 21 | 2428.6 mg/week | Standard Deviation 1592.39 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 9 | 6464.3 mg/week | Standard Deviation 6203.18 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 15 | 4700.0 mg/week | Standard Deviation 4601.93 |
| Tanezumab 2.5 mg | Amount of Rescue Medication Taken Per Week | Week 18 | 6583.3 mg/week | Standard Deviation 4128.16 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 15 | 7333.3 mg/week | Standard Deviation 8437.27 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 3 | 5368.4 mg/week | Standard Deviation 4669.17 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 4 | 5500.0 mg/week | Standard Deviation 5787.92 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 22 | 5250.0 mg/week | Standard Deviation 3489.27 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 23 | 3125.0 mg/week | Standard Deviation 1931.11 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 24 | 3625.0 mg/week | Standard Deviation 2780.14 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 5 | 4843.8 mg/week | Standard Deviation 5545.93 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 17 | 4722.2 mg/week | Standard Deviation 3392.19 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 6 | 4735.3 mg/week | Standard Deviation 6200.09 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 7 | 4928.6 mg/week | Standard Deviation 5473.21 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 8 | 5875.0 mg/week | Standard Deviation 6045.75 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 9 | 6166.7 mg/week | Standard Deviation 6087.74 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 10 | 6333.3 mg/week | Standard Deviation 6359.05 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 18 | 3714.3 mg/week | Standard Deviation 3672.61 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 11 | 5750.0 mg/week | Standard Deviation 5422.43 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 12 | 7500.0 mg/week | Standard Deviation 7861.3 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 13 | 6888.9 mg/week | Standard Deviation 6406.92 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 14 | 6250.0 mg/week | Standard Deviation 6161.03 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 16 | 6900.0 mg/week | Standard Deviation 6814.2 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Baseline | 5875.0 mg/week | Standard Deviation 4795.49 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 1 | 6375.0 mg/week | Standard Deviation 4737.52 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 19 | 4214.3 mg/week | Standard Deviation 3717.72 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 20 | 3714.3 mg/week | Standard Deviation 3186.65 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 2 | 5369.6 mg/week | Standard Deviation 5341.13 |
| Tanezumab 10 mg | Amount of Rescue Medication Taken Per Week | Week 21 | 2750.0 mg/week | Standard Deviation 2563.48 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 19 | 4214.3 mg/week | Standard Deviation 4270.61 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 8 | 6428.6 mg/week | Standard Deviation 4807.27 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 7 | 6500.0 mg/week | Standard Deviation 4263.63 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 2 | 5647.1 mg/week | Standard Deviation 4018.57 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Baseline | 5695.7 mg/week | Standard Deviation 4255.32 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 15 | 6500.0 mg/week | Standard Deviation 3909.69 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 17 | 6111.1 mg/week | Standard Deviation 6303.66 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 6 | 6500.0 mg/week | Standard Deviation 4267.12 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 21 | 7333.3 mg/week | Standard Deviation 7333.3 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 1 | 6058.8 mg/week | Standard Deviation 3273.39 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 4 | 5194.4 mg/week | Standard Deviation 4765.5 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 5 | 5694.4 mg/week | Standard Deviation 4902.4 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 16 | 6142.9 mg/week | Standard Deviation 2925.67 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 20 | 5000.0 mg/week | Standard Deviation 5167.2 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 24 | 8500.0 mg/week | Standard Deviation 5766.28 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 23 | 6666.7 mg/week | Standard Deviation 5507.57 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 22 | 6000.0 mg/week | Standard Deviation 4582.58 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 13 | 6772.7 mg/week | Standard Deviation 4808.14 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 12 | 5583.3 mg/week | Standard Deviation 5142.66 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 18 | 5583.3 mg/week | Standard Deviation 4079.42 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 3 | 6218.8 mg/week | Standard Deviation 4837.25 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 14 | 6807.7 mg/week | Standard Deviation 5717.44 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 11 | 6807.7 mg/week | Standard Deviation 7084.43 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 10 | 6916.7 mg/week | Standard Deviation 5418.12 |
| Tanezumab 20 mg | Amount of Rescue Medication Taken Per Week | Week 9 | 5958.3 mg/week | Standard Deviation 5565.55 |
Secondary
Brief Pain Inventory-Short Form (BPI-sf) Score
BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.
Time frame: Baseline, Week 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PSI | 3.86 units on a scale | Standard Deviation 2.023 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24, PII | 4.16 units on a scale | Standard Deviation 2.153 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24: PSI | 3.96 units on a scale | Standard Deviation 2.159 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PII | 4.80 units on a scale | Standard Deviation 1.963 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PSI | 4.12 units on a scale | Standard Deviation 2.072 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PII | 3.76 units on a scale | Standard Deviation 2.432 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PSI | 5.14 units on a scale | Standard Deviation 1.387 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PII | 3.59 units on a scale | Standard Deviation 2.511 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24: PSI | 3.16 units on a scale | Standard Deviation 1.871 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PII | 4.49 units on a scale | Standard Deviation 2.607 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24, PII | 3.53 units on a scale | Standard Deviation 2.739 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PII | 5.22 units on a scale | Standard Deviation 2.082 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PSI | 4.53 units on a scale | Standard Deviation 2.238 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PSI | 5.28 units on a scale | Standard Deviation 1.788 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PII | 4.67 units on a scale | Standard Deviation 2.552 |
| Tanezumab 1 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PSI | 4.28 units on a scale | Standard Deviation 2.09 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24, PII | 4.48 units on a scale | Standard Deviation 3.149 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PSI | 5.74 units on a scale | Standard Deviation 1.817 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PII | 5.49 units on a scale | Standard Deviation 2.251 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PSI | 4.84 units on a scale | Standard Deviation 2.318 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PII | 4.46 units on a scale | Standard Deviation 2.98 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PSI | 4.21 units on a scale | Standard Deviation 2.136 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PII | 4.52 units on a scale | Standard Deviation 2.715 |
| Tanezumab 2.5 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24: PSI | 3.99 units on a scale | Standard Deviation 2.376 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PSI | 4.23 units on a scale | Standard Deviation 2.417 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PII | 4.97 units on a scale | Standard Deviation 1.932 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24, PII | 4.54 units on a scale | Standard Deviation 2.246 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PSI | 5.49 units on a scale | Standard Deviation 1.904 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24: PSI | 4.57 units on a scale | Standard Deviation 2.001 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PSI | 4.30 units on a scale | Standard Deviation 2.293 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PII | 3.93 units on a scale | Standard Deviation 2.513 |
| Tanezumab 10 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PII | 3.87 units on a scale | Standard Deviation 2.6 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PSI | 4.60 units on a scale | Standard Deviation 1.984 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24: PSI | 5.16 units on a scale | Standard Deviation 1.879 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PSI | 4.51 units on a scale | Standard Deviation 1.912 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PII | 5.74 units on a scale | Standard Deviation 1.808 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Baseline: PSI | 5.82 units on a scale | Standard Deviation 1.491 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 16: PII | 4.31 units on a scale | Standard Deviation 2.467 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 8: PII | 4.61 units on a scale | Standard Deviation 2.598 |
| Tanezumab 20 mg | Brief Pain Inventory-Short Form (BPI-sf) Score | Week 24, PII | 4.39 units on a scale | Standard Deviation 2.699 |
Secondary
Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 1 | -0.45 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 20 | -1.71 units on a scale | Standard Deviation 2.207 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 6 | -0.97 units on a scale | Standard Deviation 1.65 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 15 | -1.50 units on a scale | Standard Deviation 1.785 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 12 | -1.62 units on a scale | Standard Deviation 1.598 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 22 | -1.85 units on a scale | Standard Deviation 2.38 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 19 | -1.74 units on a scale | Standard Deviation 2.096 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 7 | -1.18 units on a scale | Standard Deviation 1.814 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 4 | -1.06 units on a scale | Standard Deviation 1.559 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 14 | -1.56 units on a scale | Standard Deviation 1.882 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 24 | -2.00 units on a scale | Standard Deviation 2.278 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 18 | -1.47 units on a scale | Standard Deviation 2.248 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 9 | -1.31 units on a scale | Standard Deviation 1.774 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 13 | -1.58 units on a scale | Standard Deviation 1.751 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 21 | -1.98 units on a scale | Standard Deviation 2.264 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 5 | -1.18 units on a scale | Standard Deviation 1.576 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 17 | -1.64 units on a scale | Standard Deviation 2.182 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 10 | -1.42 units on a scale | Standard Deviation 1.881 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 3 | -1.14 units on a scale | Standard Deviation 1.521 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 23 | -1.36 units on a scale | Standard Deviation 2.701 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 2 | -0.91 units on a scale | Standard Deviation 1.296 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 16 | -1.75 units on a scale | Standard Deviation 1.728 |
| Placebo | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 11 | -1.53 units on a scale | Standard Deviation 1.77 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 19 | -2.65 units on a scale | Standard Deviation 1.508 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 15 | -1.81 units on a scale | Standard Deviation 1.71 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 12 | -1.28 units on a scale | Standard Deviation 1.768 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 3 | -0.90 units on a scale | Standard Deviation 1.642 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 14 | -1.41 units on a scale | Standard Deviation 2.195 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 13 | -1.47 units on a scale | Standard Deviation 1.944 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 24 | -2.11 units on a scale | Standard Deviation 2.083 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 22 | -2.56 units on a scale | Standard Deviation 1.833 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 4 | -1.14 units on a scale | Standard Deviation 1.797 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 21 | -2.76 units on a scale | Standard Deviation 1.515 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 5 | -1.09 units on a scale | Standard Deviation 1.686 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 20 | -2.51 units on a scale | Standard Deviation 1.487 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 6 | -1.43 units on a scale | Standard Deviation 1.815 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 2 | -0.55 units on a scale | Standard Deviation 1.151 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 11 | -1.41 units on a scale | Standard Deviation 1.961 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 7 | -1.53 units on a scale | Standard Deviation 1.894 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 1 | -0.45 units on a scale | Standard Deviation 0.997 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 18 | -2.02 units on a scale | Standard Deviation 1.894 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 9 | -1.62 units on a scale | Standard Deviation 1.844 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 23 | -2.12 units on a scale | Standard Deviation 2.012 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 17 | -1.85 units on a scale | Standard Deviation 1.882 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 10 | -1.37 units on a scale | Standard Deviation 1.93 |
| Tanezumab 1 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 16 | -1.87 units on a scale | Standard Deviation 1.915 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 13 | -2.05 units on a scale | Standard Deviation 2.129 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 1 | -0.83 units on a scale | Standard Deviation 1.715 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 2 | -1.07 units on a scale | Standard Deviation 2.039 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 3 | -1.09 units on a scale | Standard Deviation 2.135 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 4 | -1.50 units on a scale | Standard Deviation 2.153 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 5 | -1.51 units on a scale | Standard Deviation 2.121 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 6 | -1.69 units on a scale | Standard Deviation 2.084 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 7 | -1.67 units on a scale | Standard Deviation 2.308 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 9 | -1.68 units on a scale | Standard Deviation 2.439 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 10 | -1.95 units on a scale | Standard Deviation 2.628 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 11 | -2.10 units on a scale | Standard Deviation 2.504 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 12 | -1.93 units on a scale | Standard Deviation 2.177 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 14 | -1.86 units on a scale | Standard Deviation 1.988 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 15 | -2.00 units on a scale | Standard Deviation 1.959 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 16 | -2.39 units on a scale | Standard Deviation 2.546 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 17 | -2.36 units on a scale | Standard Deviation 2.376 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 18 | -2.85 units on a scale | Standard Deviation 2.521 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 19 | -2.93 units on a scale | Standard Deviation 2.555 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 20 | -2.18 units on a scale | Standard Deviation 2.226 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 21 | -1.76 units on a scale | Standard Deviation 2.227 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 22 | -1.75 units on a scale | Standard Deviation 2.626 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 23 | -1.59 units on a scale | Standard Deviation 2.168 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 24 | -1.84 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 10 | -1.61 units on a scale | Standard Deviation 1.822 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 20 | -1.73 units on a scale | Standard Deviation 2.575 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 7 | -1.61 units on a scale | Standard Deviation 2.131 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 23 | -1.20 units on a scale | Standard Deviation 1.647 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 4 | -1.41 units on a scale | Standard Deviation 1.789 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 1 | -0.39 units on a scale | Standard Deviation 0.821 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 21 | -1.99 units on a scale | Standard Deviation 2.542 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 18 | -1.95 units on a scale | Standard Deviation 2.338 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 2 | -0.73 units on a scale | Standard Deviation 1.45 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 3 | -1.10 units on a scale | Standard Deviation 1.59 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 9 | -1.74 units on a scale | Standard Deviation 2.219 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 22 | -1.49 units on a scale | Standard Deviation 1.795 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 13 | -1.83 units on a scale | Standard Deviation 2.374 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 6 | -1.42 units on a scale | Standard Deviation 2.074 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 24 | -0.94 units on a scale | Standard Deviation 1.625 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 12 | -1.84 units on a scale | Standard Deviation 2.517 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 19 | -1.86 units on a scale | Standard Deviation 2.498 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 14 | -1.68 units on a scale | Standard Deviation 2.355 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 17 | -1.95 units on a scale | Standard Deviation 2.282 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 16 | -1.76 units on a scale | Standard Deviation 2.382 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 11 | -1.85 units on a scale | Standard Deviation 2.502 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 5 | -1.52 units on a scale | Standard Deviation 2.063 |
| Tanezumab 10 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 15 | -1.68 units on a scale | Standard Deviation 2.399 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 1 | -0.43 units on a scale | Standard Deviation 1.055 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 10 | -1.98 units on a scale | Standard Deviation 1.779 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 16 | -2.29 units on a scale | Standard Deviation 1.63 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 9 | -1.74 units on a scale | Standard Deviation 1.485 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 17 | -1.97 units on a scale | Standard Deviation 1.921 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 7 | -1.66 units on a scale | Standard Deviation 1.77 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 18 | -1.98 units on a scale | Standard Deviation 1.855 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 6 | -1.47 units on a scale | Standard Deviation 1.537 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 23 | -1.59 units on a scale | Standard Deviation 2.473 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 19 | -1.77 units on a scale | Standard Deviation 1.756 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 5 | -1.56 units on a scale | Standard Deviation 1.456 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 15 | -2.03 units on a scale | Standard Deviation 1.74 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 20 | -1.96 units on a scale | Standard Deviation 1.896 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 4 | -1.41 units on a scale | Standard Deviation 1.64 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 21 | -1.81 units on a scale | Standard Deviation 2.069 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 3 | -1.17 units on a scale | Standard Deviation 1.283 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 24 | -1.58 units on a scale | Standard Deviation 1.952 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 13 | -2.16 units on a scale | Standard Deviation 1.678 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 12 | -1.94 units on a scale | Standard Deviation 1.63 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 22 | -1.97 units on a scale | Standard Deviation 1.941 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 14 | -1.85 units on a scale | Standard Deviation 1.76 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 11 | -1.95 units on a scale | Standard Deviation 1.884 |
| Tanezumab 20 mg | Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | Change at Week 2 | -0.99 units on a scale | Standard Deviation 1.273 |
Secondary
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 5 | -1.00 units on a scale | Standard Deviation 1.859 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 13 | -1.49 units on a scale | Standard Deviation 1.937 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 22 | -1.69 units on a scale | Standard Deviation 2.674 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 3 | -0.96 units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 19 | -1.54 units on a scale | Standard Deviation 2.388 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 6 | -0.85 units on a scale | Standard Deviation 1.784 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 15 | -1.34 units on a scale | Standard Deviation 1.858 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 24 | -1.91 units on a scale | Standard Deviation 2.701 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 12 | -1.56 units on a scale | Standard Deviation 1.836 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 18 | -1.34 units on a scale | Standard Deviation 2.066 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 7 | -1.06 units on a scale | Standard Deviation 1.963 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 21 | -1.73 units on a scale | Standard Deviation 2.356 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 4 | -0.87 units on a scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 11 | -1.41 units on a scale | Standard Deviation 1.999 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 17 | -1.48 units on a scale | Standard Deviation 2.138 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 8 | -1.20 units on a scale | Standard Deviation 1.927 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 1 | -0.37 units on a scale | Standard Deviation 1.097 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 23 | -1.32 units on a scale | Standard Deviation 2.749 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 14 | -1.49 units on a scale | Standard Deviation 1.982 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 16 | -1.66 units on a scale | Standard Deviation 1.878 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 9 | -1.18 units on a scale | Standard Deviation 1.94 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 20 | -1.42 units on a scale | Standard Deviation 2.318 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 2 | -0.84 units on a scale | Standard Deviation 1.363 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Baseline | 6.84 units on a scale | Standard Deviation 1.341 |
| Placebo | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 10 | -1.30 units on a scale | Standard Deviation 2.05 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 15 | -1.40 units on a scale | Standard Deviation 2.138 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 10 | -1.02 units on a scale | Standard Deviation 2.078 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 2 | -0.60 units on a scale | Standard Deviation 1.212 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 14 | -1.15 units on a scale | Standard Deviation 2.319 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 11 | -1.31 units on a scale | Standard Deviation 2.185 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 24 | -0.80 units on a scale | Standard Deviation 2.695 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 13 | -1.20 units on a scale | Standard Deviation 2.109 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 12 | -1.06 units on a scale | Standard Deviation 2.075 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 22 | -1.54 units on a scale | Standard Deviation 2.607 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 3 | -0.80 units on a scale | Standard Deviation 1.785 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 21 | -1.81 units on a scale | Standard Deviation 2.344 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 4 | -1.12 units on a scale | Standard Deviation 1.967 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 20 | -1.56 units on a scale | Standard Deviation 2.517 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 5 | -1.13 units on a scale | Standard Deviation 1.712 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 1 | -0.45 units on a scale | Standard Deviation 1.038 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 19 | -1.92 units on a scale | Standard Deviation 2.827 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 6 | -1.50 units on a scale | Standard Deviation 1.953 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Baseline | 7.29 units on a scale | Standard Deviation 1.489 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 18 | -1.50 units on a scale | Standard Deviation 2.275 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 7 | -1.59 units on a scale | Standard Deviation 2.163 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 23 | -1.01 units on a scale | Standard Deviation 2.686 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 17 | -1.27 units on a scale | Standard Deviation 2.339 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 8 | -1.07 units on a scale | Standard Deviation 1.831 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 16 | -1.48 units on a scale | Standard Deviation 2.317 |
| Tanezumab 1 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 9 | -1.32 units on a scale | Standard Deviation 2.227 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 15 | -1.64 units on a scale | Standard Deviation 1.881 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Baseline | 7.32 units on a scale | Standard Deviation 1.263 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 1 | -0.76 units on a scale | Standard Deviation 1.797 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 2 | -0.98 units on a scale | Standard Deviation 2.078 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 3 | -1.03 units on a scale | Standard Deviation 1.97 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 4 | -1.36 units on a scale | Standard Deviation 2.083 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 5 | -1.31 units on a scale | Standard Deviation 2.215 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 6 | -1.53 units on a scale | Standard Deviation 2.321 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 7 | -1.45 units on a scale | Standard Deviation 2.297 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 8 | -1.30 units on a scale | Standard Deviation 2.462 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 9 | -1.51 units on a scale | Standard Deviation 2.401 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 10 | -1.95 units on a scale | Standard Deviation 2.449 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 11 | -1.92 units on a scale | Standard Deviation 2.334 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 12 | -1.73 units on a scale | Standard Deviation 2.175 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 13 | -1.82 units on a scale | Standard Deviation 2.25 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 14 | -1.54 units on a scale | Standard Deviation 1.903 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 16 | -2.21 units on a scale | Standard Deviation 2.405 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 17 | -1.83 units on a scale | Standard Deviation 2.228 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 18 | -2.53 units on a scale | Standard Deviation 2.53 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 19 | -2.68 units on a scale | Standard Deviation 2.717 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 20 | -1.79 units on a scale | Standard Deviation 2.393 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 21 | -1.35 units on a scale | Standard Deviation 1.695 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 22 | -1.46 units on a scale | Standard Deviation 2.425 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 23 | -1.45 units on a scale | Standard Deviation 1.887 |
| Tanezumab 2.5 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 24 | -1.90 units on a scale | Standard Deviation 2.225 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 24 | -0.93 units on a scale | Standard Deviation 1.738 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 4 | -1.52 units on a scale | Standard Deviation 2.074 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 17 | -1.93 units on a scale | Standard Deviation 2.568 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 20 | -1.85 units on a scale | Standard Deviation 2.99 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 8 | -1.68 units on a scale | Standard Deviation 2.415 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 1 | -0.33 units on a scale | Standard Deviation 0.966 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 3 | -1.07 units on a scale | Standard Deviation 1.788 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Baseline | 7.15 units on a scale | Standard Deviation 1.342 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 21 | -2.24 units on a scale | Standard Deviation 2.975 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 6 | -1.48 units on a scale | Standard Deviation 2.248 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 23 | -1.20 units on a scale | Standard Deviation 1.821 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 2 | -0.72 units on a scale | Standard Deviation 1.582 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 18 | -2.06 units on a scale | Standard Deviation 2.761 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 22 | -1.62 units on a scale | Standard Deviation 2.268 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 16 | -1.89 units on a scale | Standard Deviation 2.547 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 12 | -1.84 units on a scale | Standard Deviation 2.787 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 9 | -1.74 units on a scale | Standard Deviation 2.501 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 5 | -1.71 units on a scale | Standard Deviation 2.306 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 13 | -1.86 units on a scale | Standard Deviation 2.617 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 15 | -1.80 units on a scale | Standard Deviation 2.608 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 11 | -2.00 units on a scale | Standard Deviation 2.677 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 19 | -1.92 units on a scale | Standard Deviation 2.916 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 7 | -1.77 units on a scale | Standard Deviation 2.324 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 14 | -1.69 units on a scale | Standard Deviation 2.611 |
| Tanezumab 10 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 10 | -1.77 units on a scale | Standard Deviation 2.181 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 14 | -2.00 units on a scale | Standard Deviation 2.116 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 9 | -1.92 units on a scale | Standard Deviation 1.679 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 15 | -2.12 units on a scale | Standard Deviation 2.212 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 8 | -1.78 units on a scale | Standard Deviation 1.751 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 16 | -2.39 units on a scale | Standard Deviation 2.107 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 7 | -1.73 units on a scale | Standard Deviation 1.958 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 17 | -2.08 units on a scale | Standard Deviation 2.273 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 6 | -1.53 units on a scale | Standard Deviation 1.715 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 18 | -1.99 units on a scale | Standard Deviation 2.105 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 5 | -1.69 units on a scale | Standard Deviation 1.505 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 23 | -1.28 units on a scale | Standard Deviation 2.562 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 19 | -1.66 units on a scale | Standard Deviation 2.184 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 4 | -1.42 units on a scale | Standard Deviation 1.853 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Baseline | 7.41 units on a scale | Standard Deviation 1.334 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 20 | -1.85 units on a scale | Standard Deviation 2.068 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 3 | -1.11 units on a scale | Standard Deviation 1.29 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 21 | -1.64 units on a scale | Standard Deviation 2.246 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 2 | -0.98 units on a scale | Standard Deviation 1.23 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 24 | -1.48 units on a scale | Standard Deviation 2.041 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 12 | -2.06 units on a scale | Standard Deviation 2.056 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 11 | -2.19 units on a scale | Standard Deviation 2.209 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 22 | -1.82 units on a scale | Standard Deviation 2.103 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 13 | -2.35 units on a scale | Standard Deviation 2.098 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 10 | -2.13 units on a scale | Standard Deviation 2 |
| Tanezumab 20 mg | Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 | Change at Week 1 | -0.49 units on a scale | Standard Deviation 0.954 |
Secondary
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Week 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Baseline | 0.69 units on a scale | Standard Deviation 0.209 |
| Placebo | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 8 | 0.74 units on a scale | Standard Deviation 0.235 |
| Placebo | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 16 | 0.75 units on a scale | Standard Deviation 0.221 |
| Placebo | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 24 | 0.74 units on a scale | Standard Deviation 0.174 |
| Tanezumab 1 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Baseline | 0.68 units on a scale | Standard Deviation 0.182 |
| Tanezumab 1 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 24 | 0.76 units on a scale | Standard Deviation 0.187 |
| Tanezumab 1 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 8 | 0.73 units on a scale | Standard Deviation 0.191 |
| Tanezumab 1 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 16 | 0.71 units on a scale | Standard Deviation 0.187 |
| Tanezumab 2.5 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 24 | 0.72 units on a scale | Standard Deviation 0.232 |
| Tanezumab 2.5 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 8 | 0.69 units on a scale | Standard Deviation 0.214 |
| Tanezumab 2.5 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 16 | 0.72 units on a scale | Standard Deviation 0.162 |
| Tanezumab 2.5 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Baseline | 0.56 units on a scale | Standard Deviation 0.233 |
| Tanezumab 10 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Baseline | 0.70 units on a scale | Standard Deviation 0.167 |
| Tanezumab 10 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 8 | 0.70 units on a scale | Standard Deviation 0.185 |
| Tanezumab 10 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 24 | 0.67 units on a scale | Standard Deviation 0.202 |
| Tanezumab 10 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 16 | 0.77 units on a scale | Standard Deviation 0.124 |
| Tanezumab 20 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 24 | 0.66 units on a scale | Standard Deviation 0.252 |
| Tanezumab 20 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 16 | 0.73 units on a scale | Standard Deviation 0.215 |
| Tanezumab 20 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Week 8 | 0.68 units on a scale | Standard Deviation 0.233 |
| Tanezumab 20 mg | Euro Quality of Life (EQ-5D) - Health State Profile Utility Score | Baseline | 0.61 units on a scale | Standard Deviation 0.224 |
Secondary
Mean Voided Volume Per Micturition
Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Voided Volume Per Micturition | Baseline | 142.12 milliliter | Standard Deviation 68.374 |
| Placebo | Mean Voided Volume Per Micturition | Week 24 | 138.77 milliliter | Standard Deviation 87.222 |
| Placebo | Mean Voided Volume Per Micturition | Week 20 | 131.52 milliliter | Standard Deviation 61.604 |
| Placebo | Mean Voided Volume Per Micturition | Week 8 | 132.33 milliliter | Standard Deviation 57.848 |
| Placebo | Mean Voided Volume Per Micturition | Week 4 | 130.75 milliliter | Standard Deviation 57.303 |
| Placebo | Mean Voided Volume Per Micturition | Week 12 | 136.60 milliliter | Standard Deviation 64.056 |
| Placebo | Mean Voided Volume Per Micturition | Week 16 | 141.39 milliliter | Standard Deviation 67.788 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Week 16 | 117.78 milliliter | Standard Deviation 75.291 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Week 12 | 164.68 milliliter | Standard Deviation 180.771 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Week 4 | 144.48 milliliter | Standard Deviation 110.219 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Baseline | 129.58 milliliter | Standard Deviation 57.649 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Week 20 | 118.44 milliliter | Standard Deviation 68.203 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Week 8 | 148.56 milliliter | Standard Deviation 109.21 |
| Tanezumab 1 mg | Mean Voided Volume Per Micturition | Week 24 | 124.48 milliliter | Standard Deviation 76.99 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Week 12 | 136.06 milliliter | Standard Deviation 88.539 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Baseline | 122.78 milliliter | Standard Deviation 65.259 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Week 4 | 117.45 milliliter | Standard Deviation 59.046 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Week 8 | 165.02 milliliter | Standard Deviation 114.862 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Week 16 | 112.86 milliliter | Standard Deviation 66.617 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Week 20 | 139.61 milliliter | Standard Deviation 64.196 |
| Tanezumab 2.5 mg | Mean Voided Volume Per Micturition | Week 24 | 152.99 milliliter | Standard Deviation 102.429 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Week 8 | 152.77 milliliter | Standard Deviation 86.116 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Week 16 | 180.71 milliliter | Standard Deviation 88.065 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Week 20 | 189.66 milliliter | Standard Deviation 86.58 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Week 4 | 175.99 milliliter | Standard Deviation 97.418 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Week 24 | 182.66 milliliter | Standard Deviation 95.542 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Baseline | 146.71 milliliter | Standard Deviation 71.013 |
| Tanezumab 10 mg | Mean Voided Volume Per Micturition | Week 12 | 180.01 milliliter | Standard Deviation 85.147 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Week 8 | 155.09 milliliter | Standard Deviation 106.398 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Week 24 | 174.96 milliliter | Standard Deviation 118.35 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Week 20 | 135.80 milliliter | Standard Deviation 95.869 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Baseline | 139.92 milliliter | Standard Deviation 71.064 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Week 16 | 163.20 milliliter | Standard Deviation 128.409 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Week 4 | 140.84 milliliter | Standard Deviation 91.375 |
| Tanezumab 20 mg | Mean Voided Volume Per Micturition | Week 12 | 158.35 milliliter | Standard Deviation 119.294 |
Secondary
Number of Days of Rescue Medication Usage Per Week
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 5 | 3.6 days per week | Standard Deviation 2.37 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 13 | 3.2 days per week | Standard Deviation 2.08 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 22 | 3.4 days per week | Standard Deviation 1.69 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 3 | 3.5 days per week | Standard Deviation 2.5 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 19 | 3.9 days per week | Standard Deviation 2.37 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 6 | 3.7 days per week | Standard Deviation 2.32 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 15 | 3.2 days per week | Standard Deviation 2.17 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 24 | 4.5 days per week | Standard Deviation 2.51 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 12 | 3.6 days per week | Standard Deviation 2.01 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 18 | 3.6 days per week | Standard Deviation 2 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 7 | 3.7 days per week | Standard Deviation 2.3 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 21 | 3.8 days per week | Standard Deviation 2.4 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 4 | 3.3 days per week | Standard Deviation 2.46 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 11 | 4.2 days per week | Standard Deviation 2.24 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 17 | 3.7 days per week | Standard Deviation 2.45 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 8 | 4.0 days per week | Standard Deviation 2.07 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 1 | 4.5 days per week | Standard Deviation 2.38 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 23 | 4.5 days per week | Standard Deviation 2.07 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 14 | 3.7 days per week | Standard Deviation 2.46 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 16 | 3.5 days per week | Standard Deviation 1.93 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 9 | 4.2 days per week | Standard Deviation 1.74 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 20 | 4.8 days per week | Standard Deviation 1.72 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 2 | 3.4 days per week | Standard Deviation 2.56 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Baseline | 4.1 days per week | Standard Deviation 2.18 |
| Placebo | Number of Days of Rescue Medication Usage Per Week | Week 10 | 3.1 days per week | Standard Deviation 1.92 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 15 | 4.0 days per week | Standard Deviation 2.58 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 10 | 3.7 days per week | Standard Deviation 2.05 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 2 | 3.9 days per week | Standard Deviation 2.25 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 14 | 3.8 days per week | Standard Deviation 2.25 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 11 | 4.0 days per week | Standard Deviation 2.41 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 24 | 4.0 days per week | Standard Deviation 2 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 13 | 4.3 days per week | Standard Deviation 1.64 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 12 | 4.6 days per week | Standard Deviation 1.9 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 22 | 3.2 days per week | Standard Deviation 2.14 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 3 | 3.5 days per week | Standard Deviation 2.38 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 21 | 3.4 days per week | Standard Deviation 2.51 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 4 | 3.5 days per week | Standard Deviation 2.42 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 20 | 3.2 days per week | Standard Deviation 2.59 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 5 | 4.6 days per week | Standard Deviation 2.19 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 1 | 4.0 days per week | Standard Deviation 2.21 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 19 | 2.5 days per week | Standard Deviation 1.41 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 6 | 3.3 days per week | Standard Deviation 2.2 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Baseline | 3.6 days per week | Standard Deviation 2.39 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 18 | 3.3 days per week | Standard Deviation 1.6 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 7 | 5.0 days per week | Standard Deviation 2 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 23 | 3.6 days per week | Standard Deviation 2.3 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 17 | 3.3 days per week | Standard Deviation 2.29 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 8 | 4.6 days per week | Standard Deviation 1.91 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 16 | 4.7 days per week | Standard Deviation 2.16 |
| Tanezumab 1 mg | Number of Days of Rescue Medication Usage Per Week | Week 9 | 4.6 days per week | Standard Deviation 1.76 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 15 | 3.6 days per week | Standard Deviation 2.59 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Baseline | 3.8 days per week | Standard Deviation 2.27 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 1 | 3.8 days per week | Standard Deviation 2.32 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 2 | 3.6 days per week | Standard Deviation 2.42 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 3 | 3.9 days per week | Standard Deviation 2.49 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 4 | 3.1 days per week | Standard Deviation 2.35 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 5 | 3.9 days per week | Standard Deviation 2.66 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 6 | 3.8 days per week | Standard Deviation 2.22 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 7 | 3.9 days per week | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 8 | 3.8 days per week | Standard Deviation 2.58 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 9 | 4.1 days per week | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 10 | 4.4 days per week | Standard Deviation 2.46 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 11 | 4.2 days per week | Standard Deviation 2.32 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 12 | 5.0 days per week | Standard Deviation 2.5 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 13 | 4.7 days per week | Standard Deviation 2.83 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 14 | 4.6 days per week | Standard Deviation 2.07 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 16 | 4.1 days per week | Standard Deviation 1.95 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 17 | 4.4 days per week | Standard Deviation 2.15 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 18 | 4.5 days per week | Standard Deviation 1.64 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 19 | 4.6 days per week | Standard Deviation 2.51 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 20 | 4.0 days per week | Standard Deviation 2.39 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 21 | 2.3 days per week | Standard Deviation 1.38 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 22 | 4.3 days per week | Standard Deviation 2.75 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 23 | 4.3 days per week | Standard Deviation 2.06 |
| Tanezumab 2.5 mg | Number of Days of Rescue Medication Usage Per Week | Week 24 | 7.0 days per week | Standard Deviation 0 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 1 | 4.6 days per week | Standard Deviation 2.01 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 9 | 4.1 days per week | Standard Deviation 2.43 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 15 | 3.3 days per week | Standard Deviation 2.4 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 8 | 3.6 days per week | Standard Deviation 2.61 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 16 | 3.9 days per week | Standard Deviation 2.81 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 7 | 3.5 days per week | Standard Deviation 2.38 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 10 | 4.2 days per week | Standard Deviation 2.86 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 17 | 3.4 days per week | Standard Deviation 2.46 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 6 | 2.22 days per week | Standard Deviation 2.33 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 18 | 3.1 days per week | Standard Deviation 2.67 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 5 | 3.3 days per week | Standard Deviation 2.57 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 23 | 2.8 days per week | Standard Deviation 2.22 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 19 | 3.7 days per week | Standard Deviation 2.43 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 4 | 3.7 days per week | Standard Deviation 2.4 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 20 | 3.3 days per week | Standard Deviation 1.98 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 3 | 3.6 days per week | Standard Deviation 2.27 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 21 | 2.4 days per week | Standard Deviation 2.13 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 24 | 3.3 days per week | Standard Deviation 2.87 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 2 | 3.7 days per week | Standard Deviation 2.38 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Baseline | 4.1 days per week | Standard Deviation 2.36 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 12 | 4.1 days per week | Standard Deviation 2.43 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 22 | 3.2 days per week | Standard Deviation 2.14 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 13 | 4.8 days per week | Standard Deviation 2.28 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 11 | 3.9 days per week | Standard Deviation 2.64 |
| Tanezumab 10 mg | Number of Days of Rescue Medication Usage Per Week | Week 14 | 4.3 days per week | Standard Deviation 2.58 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 4 | 3.9 days per week | Standard Deviation 2.63 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 9 | 3.8 days per week | Standard Deviation 2.37 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 13 | 4.5 days per week | Standard Deviation 2.21 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 23 | 4.7 days per week | Standard Deviation 3.21 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 15 | 5.0 days per week | Standard Deviation 2 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 8 | 4.3 days per week | Standard Deviation 2.05 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 12 | 3.8 days per week | Standard Deviation 2.41 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 1 | 4.8 days per week | Standard Deviation 1.68 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 20 | 4.0 days per week | Standard Deviation 2.37 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 16 | 4.6 days per week | Standard Deviation 1.27 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 7 | 4.5 days per week | Standard Deviation 2.36 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 3 | 4.3 days per week | Standard Deviation 2.27 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 14 | 4.1 days per week | Standard Deviation 2.36 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Baseline | 4.6 days per week | Standard Deviation 2.08 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 17 | 3.7 days per week | Standard Deviation 2.18 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 6 | 4.5 days per week | Standard Deviation 2.6 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 11 | 4.1 days per week | Standard Deviation 2.6 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 24 | 5.7 days per week | Standard Deviation 2.31 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 21 | 5.7 days per week | Standard Deviation 1.53 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 18 | 4.7 days per week | Standard Deviation 2.42 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 5 | 4.2 days per week | Standard Deviation 2.53 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 2 | 4.2 days per week | Standard Deviation 2.31 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 10 | 4.3 days per week | Standard Deviation 2.46 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 22 | 4.7 days per week | Standard Deviation 3.21 |
| Tanezumab 20 mg | Number of Days of Rescue Medication Usage Per Week | Week 19 | 3.6 days per week | Standard Deviation 2.57 |
Secondary
Number of Micturition-related Urgency Episodes Per 24 Hours
The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 4 | 4.64 urgency episodes per 24 hours | Standard Deviation 5.68 |
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Baseline | 6.88 urgency episodes per 24 hours | Standard Deviation 6.721 |
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 8 | 6.06 urgency episodes per 24 hours | Standard Deviation 7.493 |
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 24 | 4.53 urgency episodes per 24 hours | Standard Deviation 6.286 |
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 20 | 3.81 urgency episodes per 24 hours | Standard Deviation 5.482 |
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 16 | 4.78 urgency episodes per 24 hours | Standard Deviation 6.254 |
| Placebo | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 12 | 4.90 urgency episodes per 24 hours | Standard Deviation 6.575 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 12 | 5.73 urgency episodes per 24 hours | Standard Deviation 5.419 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Baseline | 7.04 urgency episodes per 24 hours | Standard Deviation 6.04 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 4 | 6.90 urgency episodes per 24 hours | Standard Deviation 7.56 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 8 | 6.50 urgency episodes per 24 hours | Standard Deviation 7.674 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 16 | 5.06 urgency episodes per 24 hours | Standard Deviation 4.473 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 20 | 4.62 urgency episodes per 24 hours | Standard Deviation 5.341 |
| Tanezumab 1 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 24 | 3.65 urgency episodes per 24 hours | Standard Deviation 5.695 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 20 | 5.37 urgency episodes per 24 hours | Standard Deviation 5.84 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 4 | 8.27 urgency episodes per 24 hours | Standard Deviation 10.391 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 8 | 5.86 urgency episodes per 24 hours | Standard Deviation 5.213 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 24 | 6.80 urgency episodes per 24 hours | Standard Deviation 6.568 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 16 | 6.52 urgency episodes per 24 hours | Standard Deviation 6.374 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 12 | 5.89 urgency episodes per 24 hours | Standard Deviation 5.035 |
| Tanezumab 2.5 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Baseline | 9.24 urgency episodes per 24 hours | Standard Deviation 7.665 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 24 | 6.62 urgency episodes per 24 hours | Standard Deviation 8.546 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 8 | 6.51 urgency episodes per 24 hours | Standard Deviation 7.504 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 12 | 5.09 urgency episodes per 24 hours | Standard Deviation 4.852 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 4 | 5.97 urgency episodes per 24 hours | Standard Deviation 4.849 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Baseline | 8.38 urgency episodes per 24 hours | Standard Deviation 5.774 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 20 | 5.09 urgency episodes per 24 hours | Standard Deviation 5.565 |
| Tanezumab 10 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 16 | 4.34 urgency episodes per 24 hours | Standard Deviation 4.94 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 24 | 6.43 urgency episodes per 24 hours | Standard Deviation 7.734 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 8 | 6.23 urgency episodes per 24 hours | Standard Deviation 8.625 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Baseline | 7.20 urgency episodes per 24 hours | Standard Deviation 6.842 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 12 | 5.31 urgency episodes per 24 hours | Standard Deviation 6.597 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 16 | 6.01 urgency episodes per 24 hours | Standard Deviation 6.511 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 20 | 7.40 urgency episodes per 24 hours | Standard Deviation 8.167 |
| Tanezumab 20 mg | Number of Micturition-related Urgency Episodes Per 24 Hours | Week 4 | 6.91 urgency episodes per 24 hours | Standard Deviation 8.82 |
Secondary
Number of Micturitions Per 24 Hours
The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Micturitions Per 24 Hours | Baseline | 12.98 micturitions per 24 hours | Standard Deviation 5.207 |
| Placebo | Number of Micturitions Per 24 Hours | Week 24 | 11.10 micturitions per 24 hours | Standard Deviation 6.19 |
| Placebo | Number of Micturitions Per 24 Hours | Week 20 | 10.82 micturitions per 24 hours | Standard Deviation 6.034 |
| Placebo | Number of Micturitions Per 24 Hours | Week 8 | 11.61 micturitions per 24 hours | Standard Deviation 5.662 |
| Placebo | Number of Micturitions Per 24 Hours | Week 4 | 11.03 micturitions per 24 hours | Standard Deviation 4.867 |
| Placebo | Number of Micturitions Per 24 Hours | Week 12 | 10.19 micturitions per 24 hours | Standard Deviation 5.265 |
| Placebo | Number of Micturitions Per 24 Hours | Week 16 | 9.24 micturitions per 24 hours | Standard Deviation 4.94 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Week 16 | 11.27 micturitions per 24 hours | Standard Deviation 4.892 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Week 12 | 12.88 micturitions per 24 hours | Standard Deviation 7.234 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Week 4 | 11.81 micturitions per 24 hours | Standard Deviation 6.843 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Baseline | 13.04 micturitions per 24 hours | Standard Deviation 5.5 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Week 20 | 12.11 micturitions per 24 hours | Standard Deviation 5.985 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Week 8 | 12.18 micturitions per 24 hours | Standard Deviation 6.675 |
| Tanezumab 1 mg | Number of Micturitions Per 24 Hours | Week 24 | 10.67 micturitions per 24 hours | Standard Deviation 5.871 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Week 12 | 10.58 micturitions per 24 hours | Standard Deviation 4.933 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Baseline | 14.12 micturitions per 24 hours | Standard Deviation 6.728 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Week 4 | 11.41 micturitions per 24 hours | Standard Deviation 5.735 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Week 8 | 10.39 micturitions per 24 hours | Standard Deviation 4.842 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Week 16 | 10.93 micturitions per 24 hours | Standard Deviation 3.81 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Week 20 | 9.61 micturitions per 24 hours | Standard Deviation 4.987 |
| Tanezumab 2.5 mg | Number of Micturitions Per 24 Hours | Week 24 | 10.67 micturitions per 24 hours | Standard Deviation 5.571 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Week 8 | 11.52 micturitions per 24 hours | Standard Deviation 7.009 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Week 16 | 8.90 micturitions per 24 hours | Standard Deviation 6.212 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Week 4 | 10.62 micturitions per 24 hours | Standard Deviation 6.635 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Week 24 | 11.36 micturitions per 24 hours | Standard Deviation 5.575 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Week 20 | 10.17 micturitions per 24 hours | Standard Deviation 7.354 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Baseline | 13.27 micturitions per 24 hours | Standard Deviation 5.403 |
| Tanezumab 10 mg | Number of Micturitions Per 24 Hours | Week 12 | 10.21 micturitions per 24 hours | Standard Deviation 6.185 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Week 8 | 11.13 micturitions per 24 hours | Standard Deviation 7.754 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Week 24 | 11.04 micturitions per 24 hours | Standard Deviation 6.417 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Week 20 | 12.26 micturitions per 24 hours | Standard Deviation 7.272 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Week 16 | 9.99 micturitions per 24 hours | Standard Deviation 5.355 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Week 4 | 13.14 micturitions per 24 hours | Standard Deviation 7.93 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Baseline | 13.13 micturitions per 24 hours | Standard Deviation 5.681 |
| Tanezumab 20 mg | Number of Micturitions Per 24 Hours | Week 12 | 10.15 micturitions per 24 hours | Standard Deviation 5.695 |
Secondary
Number of Nocturnal Micturitions Per 24 Hours
The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Baseline | 2.63 micturitions per 24 hours | Standard Deviation 1.641 |
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Week 24 | 2.15 micturitions per 24 hours | Standard Deviation 1.693 |
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Week 20 | 2.95 micturitions per 24 hours | Standard Deviation 3.031 |
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Week 8 | 2.58 micturitions per 24 hours | Standard Deviation 1.982 |
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Week 4 | 2.25 micturitions per 24 hours | Standard Deviation 1.634 |
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Week 12 | 1.97 micturitions per 24 hours | Standard Deviation 1.326 |
| Placebo | Number of Nocturnal Micturitions Per 24 Hours | Week 16 | 2.45 micturitions per 24 hours | Standard Deviation 3.141 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 16 | 3.55 micturitions per 24 hours | Standard Deviation 2.982 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 12 | 2.87 micturitions per 24 hours | Standard Deviation 2.023 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 4 | 3.40 micturitions per 24 hours | Standard Deviation 2.904 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Baseline | 3.34 micturitions per 24 hours | Standard Deviation 2.379 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 20 | 4.60 micturitions per 24 hours | Standard Deviation 4.302 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 8 | 3.18 micturitions per 24 hours | Standard Deviation 2.094 |
| Tanezumab 1 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 24 | 3.45 micturitions per 24 hours | Standard Deviation 2.132 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 12 | 2.62 micturitions per 24 hours | Standard Deviation 1.371 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Baseline | 2.66 micturitions per 24 hours | Standard Deviation 1.85 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 4 | 2.85 micturitions per 24 hours | Standard Deviation 1.72 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 8 | 2.44 micturitions per 24 hours | Standard Deviation 1.851 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 16 | 2.77 micturitions per 24 hours | Standard Deviation 1.456 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 20 | 2.29 micturitions per 24 hours | Standard Deviation 1.279 |
| Tanezumab 2.5 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 24 | 2.68 micturitions per 24 hours | Standard Deviation 1.426 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 8 | 3.12 micturitions per 24 hours | Standard Deviation 3.316 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 16 | 2.17 micturitions per 24 hours | Standard Deviation 1.789 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 4 | 2.44 micturitions per 24 hours | Standard Deviation 2.671 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 24 | 3.39 micturitions per 24 hours | Standard Deviation 3.731 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 20 | 2.96 micturitions per 24 hours | Standard Deviation 2.937 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Baseline | 3.39 micturitions per 24 hours | Standard Deviation 2.667 |
| Tanezumab 10 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 12 | 2.02 micturitions per 24 hours | Standard Deviation 2.106 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 8 | 2.73 micturitions per 24 hours | Standard Deviation 2.258 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 24 | 2.56 micturitions per 24 hours | Standard Deviation 1.891 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 20 | 3.89 micturitions per 24 hours | Standard Deviation 3.129 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 16 | 2.31 micturitions per 24 hours | Standard Deviation 1.949 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 4 | 2.72 micturitions per 24 hours | Standard Deviation 2.601 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Baseline | 2.95 micturitions per 24 hours | Standard Deviation 1.761 |
| Tanezumab 20 mg | Number of Nocturnal Micturitions Per 24 Hours | Week 12 | 2.71 micturitions per 24 hours | Standard Deviation 2.023 |
Secondary
Number of Participants With Global Response Assessment Scores
Participants were asked: compared to when you began this trial, how would you rate your IC/PBS symptoms now? Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.
Time frame: Week 8, 16, 24
Population: ITT analysis set. Missing values were imputed using last observation carried forward (LOCF) method. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Worse | 2 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: No Change | 7 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Improved | 3 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Improved | 3 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Improved | 2 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Improved | 4 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: No Change | 13 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Worse | 3 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: No Change | 9 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Improved | 8 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Improved | 10 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Improved | 3 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Improved | 6 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Improved | 8 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Worse | 1 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Worse | 4 Participants |
| Placebo | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Worse | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: No Change | 13 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Worse | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Improved | 12 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Worse | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Improved | 5 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Improved | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Worse | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Worse | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: No Change | 12 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Worse | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Worse | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Improved | 8 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: No Change | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Worse | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Worse | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Improved | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Improved | 5 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Improved | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Improved | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Improved | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Worse | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Improved | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Worse | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Worse | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Improved | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Worse | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Worse | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Improved | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Worse | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Improved | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Worse | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: No Change | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: No Change | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Worse | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Worse | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Worse | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Improved | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Improved | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 16: No Change | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Improved | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Improved | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Improved | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Worse | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Improved | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Improved | 9 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Improved | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Improved | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Worse | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Worse | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Worse | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: No Change | 9 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Improved | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Improved | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Improved | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Worse | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Worse | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Worse | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: No Change | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Improved | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Improved | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Worse | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Worse | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Global Response Assessment Scores | Week 8: No Change | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: No Change | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Worse | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: No Change | 14 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Worse | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Worse | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Improved | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Improved | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Improved | 8 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Worse | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: No Change | 13 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: Slightly Worse | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: Moderately Worse | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Improved | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: Slightly Worse | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 16: Markedly Worse | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: Markedly Improved | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 8: Moderately Improved | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Improved | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: Moderately Worse | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: Markedly Improved | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Global Response Assessment Scores | Week 24: Slightly Improved | 5 Participants |
Comparison: Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.p-value: 0.573195% CI: [0.56, 2.848]Regression, Logistic
Comparison: Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.p-value: 0.259295% CI: [0.689, 3.98]Regression, Logistic
Comparison: Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.p-value: 1.04595% CI: [0.452, 2.417]Regression, Logistic
Comparison: Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.p-value: 0.528995% CI: [0.569, 2.997]Regression, Logistic
Comparison: Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.p-value: 0.79395% CI: [0.385, 2.074]Regression, Logistic
Comparison: Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.p-value: 0.738695% CI: [0.471, 2.892]Regression, Logistic
Comparison: Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.p-value: 0.935495% CI: [0.437, 2.46]Regression, Logistic
Comparison: Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.p-value: 0.620795% CI: [0.341, 1.899]Regression, Logistic
Secondary
Number of Participants With Patient Global Preference Assessment Score
Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.
Time frame: Week 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: Drug Taken by Mouth | 12 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Given Into Bladder | 7 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: Physical Therapies | 6 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week8:Slight Pref Prior T/T | 4 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Taken by Mouth | 24 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Preference | 14 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Surgery | 3 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Preference | 16 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8:Slight Pref Current | 9 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Treatment | 6 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Current Drug | 9 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16:Slight Pref Current | 7 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: Surgery | 1 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: Def Pref Current Drug | 8 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Treatment | 2 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Treatment | 6 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: Def Pref Current Drug | 6 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16:Def Pref Prior | 1 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: Surgery | 5 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24:Slight Pref Current | 4 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: Toileting Programs | 2 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: Drug Taken by Mouth | 21 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Preference | 7 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24: Slight Pref Prior T/T | 1 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24:Lifestyle Interventions | 8 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16:Drug Given Into Bladder | 5 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24:Def Pref Prior | 1 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week16:Slight Pref Prior T/T | 1 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: Toileting Programs | 2 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Lifestyle Interventions | 16 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16: Physical Therapies | 6 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Physical Therapies | 8 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 24:Drug Given Into Bladder | 3 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 16:Lifestyle Interventions | 15 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Toileting Programs | 2 Participants |
| Placebo | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Prior | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Surgery | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Def Pref Prior | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Given Into Bladder | 9 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Prior | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Slight Pref Current | 5 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Preference | 12 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Physical Therapies | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Taken by Mouth | 20 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Preference | 7 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Drug Taken by Mouth | 17 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8:Slight Pref Current | 8 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Physical Therapies | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Surgery | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Drug Given Into Bladder | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Preference | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Current Drug | 11 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Toileting Programs | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Treatment | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week8:Slight Pref Prior T/T | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Drug Taken by Mouth | 9 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Physical Therapies | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Slight Pref Current | 8 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Drug Given Into Bladder | 8 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Lifestyle Interventions | 17 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Surgery | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Lifestyle Interventions | 7 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Def Pref Current Drug | 8 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Slight Pref Prior T/T | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week16:Slight Pref Prior T/T | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Treatment | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Def Pref Prior | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Treatment | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Toileting Programs | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Toileting Programs | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Def Pref Current Drug | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Lifestyle Interventions | 14 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Drug Given Into Bladder | 9 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Lifestyle Interventions | 10 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Physical Therapies | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Toileting Programs | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Drug Given Into Bladder | 9 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Drug Taken by Mouth | 12 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Surgery | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Treatment | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Def Pref Current Drug | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Slight Pref Current | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Preference | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Slight Pref Prior T/T | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Def Pref Prior | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Lifestyle Interventions | 16 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Physical Therapies | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Toileting Programs | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Given Into Bladder | 9 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Taken by Mouth | 17 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Surgery | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Treatment | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Current Drug | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8:Slight Pref Current | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Preference | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week8:Slight Pref Prior T/T | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Prior | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Lifestyle Interventions | 9 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Physical Therapies | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Toileting Programs | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Drug Taken by Mouth | 11 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Surgery | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Treatment | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Def Pref Current Drug | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Slight Pref Current | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Preference | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week16:Slight Pref Prior T/T | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Def Pref Prior | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Slight Pref Current | 8 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week8:Slight Pref Prior T/T | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Toileting Programs | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Prior | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Physical Therapies | 8 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Toileting Programs | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Lifestyle Interventions | 12 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Lifestyle Interventions | 17 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Physical Therapies | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Def Pref Prior | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week16:Slight Pref Prior T/T | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Toileting Programs | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Slight Pref Prior T/T | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Preference | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Drug Given Into Bladder | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Slight Pref Current | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Drug Taken by Mouth | 16 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Def Pref Current Drug | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Physical Therapies | 6 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Surgery | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Treatment | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Treatment | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Surgery | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Lifestyle Interventions | 7 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Def Pref Current Drug | 7 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Drug Taken by Mouth | 12 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Def Pref Prior | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Given Into Bladder | 8 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Treatment | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Drug Given Into Bladder | 6 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Current Drug | 7 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Surgery | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8:Slight Pref Current | 6 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Taken by Mouth | 22 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Preference | 9 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Preference | 15 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Taken by Mouth | 20 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Toileting Programs | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Preference | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Physical Therapies | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week8:Slight Pref Prior T/T | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Slight Pref Current | 8 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Physical Therapies | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Toileting Programs | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Drug Given Into Bladder | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Prior | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Surgery | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Lifestyle Interventions | 14 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Treatment | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Treatment | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Lifestyle Interventions | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Def Pref Prior | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Def Pref Prior | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Lifestyle Interventions | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: No Treatment | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Physical Therapies | 8 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Surgery | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Slight Pref Prior T/T | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Surgery | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Drug Given Into Bladder | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Toileting Programs | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8:Slight Pref Current | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: No Preference | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Def Pref Current Drug | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Drug Taken by Mouth | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16:Drug Given Into Bladder | 9 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24:Slight Pref Current | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: Def Pref Current Drug | 7 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week16:Slight Pref Prior T/T | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 8: No Preference | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 16: Drug Taken by Mouth | 16 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Preference Assessment Score | Week 24: Def Pref Current Drug | 4 Participants |
Secondary
Number of Participants With Patient Global Satisfaction Assessment Scores
Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: Overall, how satisfied are you with the drug that you received since you entered this trial? Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.
Time frame: Week 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Satisfied | 12 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfy/Dissatisfy | 14 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week16: Satisfy/Dissatisfy | 11 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfied | 4 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Dissatisf | 1 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfy/Dissatisfy | 7 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Dissatisfied | 6 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Dissatisf | 1 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Dissatisfied | 6 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Satisfied | 5 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Dissatisf | 1 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Satisfied | 6 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Dissatisfied | 1 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Satisfied | 3 Participants |
| Placebo | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfied | 12 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Satisfied | 6 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Satisfied | 5 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Dissatisfied | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfied | 11 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfy/Dissatisfy | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Dissatisf | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week16: Satisfy/Dissatisfy | 10 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Satisfied | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfy/Dissatisfy | 14 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Dissatisfied | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Dissatisf | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Dissatisf | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Dissatisfied | 7 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Satisfied | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfied | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Satisfied | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Dissatisf | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Satisfied | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfy/Dissatisfy | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Dissatisfied | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Dissatisf | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Dissatisf | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Satisfied | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfy/Dissatisfy | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Satisfied | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week16: Satisfy/Dissatisfy | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfied | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Dissatisfied | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Dissatisfied | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfied | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Dissatisfied | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Satisfied | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfied | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfy/Dissatisfy | 17 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Dissatisf | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Satisfied | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Satisfied | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week16: Satisfy/Dissatisfy | 11 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Dissatisfied | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Dissatisf | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Satisfied | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfied | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfy/Dissatisfy | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Dissatisfied | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Dissatisf | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfied | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week16: Satisfy/Dissatisfy | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Satisfied | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Satisfied | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Satisfied | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Satisfy/Dissatisfy | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Extremely Dissatisf | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Dissatisfied | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Dissatisf | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Dissatisfied | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfy/Dissatisfy | 11 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 24: Extremely Satisfied | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Extremely Dissatisf | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 16: Dissatisfied | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Patient Global Satisfaction Assessment Scores | Week 8: Satisfied | 9 Participants |
Secondary
Number of Participants With Willingness to Re-use Medicine Assessment
Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis? Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).
Time frame: Week 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely not Want | 1 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might not Want | 6 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Not Sure | 11 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely Want | 12 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might not Want | 3 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Not Sure | 13 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Not Sure | 4 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might not Want | 1 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely not Want | 2 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might Want | 4 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely not Want | 1 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might Want | 11 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely Want | 6 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely Want | 3 Participants |
| Placebo | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might Want | 12 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely Want | 6 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might Want | 5 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely Want | 12 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might not Want | 7 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might not Want | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely Want | 5 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Not Sure | 10 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might Want | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might not Want | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might Want | 10 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely not Want | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Not Sure | 11 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely not Want | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Not Sure | 7 Participants |
| Tanezumab 1 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely not Want | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Not Sure | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely Want | 10 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might Want | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Not Sure | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might not Want | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely not Want | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely Want | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might Want | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might not Want | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely not Want | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely Want | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might Want | 4 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Not Sure | 5 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might not Want | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely not Want | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely Want | 7 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Not Sure | 10 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely not Want | 4 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Not Sure | 6 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely not Want | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might not Want | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might Want | 9 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely not Want | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Not Sure | 11 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely Want | 10 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might Want | 2 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might Want | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might not Want | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might not Want | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely Want | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might not Want | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might not Want | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely not Want | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely not Want | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Definitely Want | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely Want | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might not Want | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Might Want | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Not Sure | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Definitely not Want | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 24: Not Sure | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 8: Might Want | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Not Sure | 12 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Might Want | 5 Participants |
| Tanezumab 20 mg | Number of Participants With Willingness to Re-use Medicine Assessment | Week 16: Definitely Want | 3 Participants |
Secondary
Number of Rescue Medication Doses Used Per Week
In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 21 | 3.83 doses per week | Standard Deviation 2.4 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 20 | 4.83 doses per week | Standard Deviation 1.72 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 16 | 3.50 doses per week | Standard Deviation 1.93 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 12 | 3.64 doses per week | Standard Deviation 2.01 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 19 | 3.89 doses per week | Standard Deviation 2.37 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 18 | 3.63 doses per week | Standard Deviation 2 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 17 | 3.67 doses per week | Standard Deviation 2.45 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 11 | 4.23 doses per week | Standard Deviation 2.24 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 7 | 3.69 doses per week | Standard Deviation 2.3 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 6 | 3.67 doses per week | Standard Deviation 2.32 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 5 | 3.64 doses per week | Standard Deviation 2.37 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 13 | 3.15 doses per week | Standard Deviation 2.08 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 10 | 3.13 doses per week | Standard Deviation 1.92 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 4 | 3.29 doses per week | Standard Deviation 2.46 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 3 | 3.53 doses per week | Standard Deviation 2.5 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 2 | 3.43 doses per week | Standard Deviation 2.56 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 14 | 3.69 doses per week | Standard Deviation 2.46 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 9 | 4.23 doses per week | Standard Deviation 1.74 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 1 | 4.50 doses per week | Standard Deviation 2.38 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Baseline | 4.09 doses per week | Standard Deviation 2.18 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 24 | 4.50 doses per week | Standard Deviation 2.51 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 15 | 3.17 doses per week | Standard Deviation 2.17 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 8 | 4.00 doses per week | Standard Deviation 2.07 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 23 | 4.50 doses per week | Standard Deviation 2.07 |
| Placebo | Number of Rescue Medication Doses Used Per Week | Week 22 | 3.38 doses per week | Standard Deviation 1.69 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 1 | 4.05 doses per week | Standard Deviation 2.21 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 11 | 4.00 doses per week | Standard Deviation 2.41 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 12 | 4.60 doses per week | Standard Deviation 1.9 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 13 | 4.30 doses per week | Standard Deviation 1.64 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 14 | 3.80 doses per week | Standard Deviation 2.25 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 15 | 4.00 doses per week | Standard Deviation 2.58 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 16 | 4.67 doses per week | Standard Deviation 2.16 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 17 | 3.29 doses per week | Standard Deviation 2.29 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 18 | 3.29 doses per week | Standard Deviation 1.6 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 19 | 2.50 doses per week | Standard Deviation 1.41 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 20 | 3.20 doses per week | Standard Deviation 2.59 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 21 | 3.40 doses per week | Standard Deviation 2.51 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 22 | 3.17 doses per week | Standard Deviation 2.14 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 23 | 3.60 doses per week | Standard Deviation 2.3 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 24 | 4.00 doses per week | Standard Deviation 2 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Baseline | 3.56 doses per week | Standard Deviation 2.39 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 2 | 3.86 doses per week | Standard Deviation 2.25 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 3 | 3.48 doses per week | Standard Deviation 2.38 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 4 | 3.45 doses per week | Standard Deviation 2.42 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 5 | 4.56 doses per week | Standard Deviation 2.19 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 6 | 3.25 doses per week | Standard Deviation 2.2 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 7 | 5.00 doses per week | Standard Deviation 2 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 8 | 4.57 doses per week | Standard Deviation 1.91 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 9 | 4.62 doses per week | Standard Deviation 1.76 |
| Tanezumab 1 mg | Number of Rescue Medication Doses Used Per Week | Week 10 | 3.71 doses per week | Standard Deviation 2.05 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 6 | 3.79 doses per week | Standard Deviation 2.22 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 14 | 4.63 doses per week | Standard Deviation 2.07 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 19 | 4.60 doses per week | Standard Deviation 2.51 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 1 | 3.78 doses per week | Standard Deviation 2.32 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 16 | 4.14 doses per week | Standard Deviation 1.95 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 5 | 3.93 doses per week | Standard Deviation 2.66 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 11 | 4.18 doses per week | Standard Deviation 2.32 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 9 | 4.07 doses per week | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 2 | 3.55 doses per week | Standard Deviation 2.42 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 18 | 4.50 doses per week | Standard Deviation 1.64 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 4 | 3.06 doses per week | Standard Deviation 2.35 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 23 | 4.25 doses per week | Standard Deviation 2.06 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 20 | 4.00 doses per week | Standard Deviation 2.39 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 3 | 3.89 doses per week | Standard Deviation 2.49 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 7 | 3.93 doses per week | Standard Deviation 2.37 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 13 | 4.67 doses per week | Standard Deviation 2.83 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 17 | 4.43 doses per week | Standard Deviation 2.15 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 15 | 3.60 doses per week | Standard Deviation 2.59 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 24 | 7.00 doses per week | Standard Deviation 0 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 21 | 2.29 doses per week | Standard Deviation 1.38 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 10 | 4.36 doses per week | Standard Deviation 2.46 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 22 | 4.25 doses per week | Standard Deviation 2.75 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 12 | 5.00 doses per week | Standard Deviation 2.5 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Baseline | 3.81 doses per week | Standard Deviation 2.27 |
| Tanezumab 2.5 mg | Number of Rescue Medication Doses Used Per Week | Week 8 | 3.85 doses per week | Standard Deviation 2.58 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 20 | 3.29 doses per week | Standard Deviation 1.98 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 15 | 3.33 doses per week | Standard Deviation 2.4 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 21 | 2.38 doses per week | Standard Deviation 2.13 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 8 | 3.58 doses per week | Standard Deviation 2.61 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 22 | 3.17 doses per week | Standard Deviation 2.14 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 23 | 2.75 doses per week | Standard Deviation 2.22 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 11 | 3.90 doses per week | Standard Deviation 2.64 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 24 | 3.25 doses per week | Standard Deviation 2.87 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 14 | 4.30 doses per week | Standard Deviation 2.58 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Baseline | 4.10 doses per week | Standard Deviation 2.36 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 7 | 3.50 doses per week | Standard Deviation 2.38 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 1 | 4.55 doses per week | Standard Deviation 2.01 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 2 | 3.70 doses per week | Standard Deviation 2.38 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 13 | 4.78 doses per week | Standard Deviation 2.28 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 9 | 4.08 doses per week | Standard Deviation 2.43 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 3 | 3.58 doses per week | Standard Deviation 2.27 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 4 | 3.67 doses per week | Standard Deviation 2.4 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 5 | 3.25 doses per week | Standard Deviation 2.57 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 12 | 4.09 doses per week | Standard Deviation 2.43 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 6 | 3.06 doses per week | Standard Deviation 2.33 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 17 | 3.44 doses per week | Standard Deviation 2.46 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 16 | 3.90 doses per week | Standard Deviation 2.81 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 18 | 3.14 doses per week | Standard Deviation 2.67 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 19 | 3.71 doses per week | Standard Deviation 2.43 |
| Tanezumab 10 mg | Number of Rescue Medication Doses Used Per Week | Week 10 | 4.22 doses per week | Standard Deviation 2.86 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 5 | 4.22 doses per week | Standard Deviation 2.53 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 22 | 4.67 doses per week | Standard Deviation 3.21 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 7 | 4.47 doses per week | Standard Deviation 2.36 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Baseline | 4.61 doses per week | Standard Deviation 2.08 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 21 | 5.67 doses per week | Standard Deviation 1.53 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 6 | 4.54 doses per week | Standard Deviation 2.6 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 10 | 4.33 doses per week | Standard Deviation 2.46 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 16 | 4.57 doses per week | Standard Deviation 1.27 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 24 | 5.67 doses per week | Standard Deviation 2.31 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 14 | 4.08 doses per week | Standard Deviation 2.36 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 19 | 3.57 doses per week | Standard Deviation 2.57 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 17 | 3.67 doses per week | Standard Deviation 2.18 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 15 | 5.00 doses per week | Standard Deviation 2 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 23 | 4.67 doses per week | Standard Deviation 3.21 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 8 | 4.29 doses per week | Standard Deviation 2.05 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 20 | 4.00 doses per week | Standard Deviation 2.37 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 3 | 4.31 doses per week | Standard Deviation 2.27 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 9 | 3.83 doses per week | Standard Deviation 2.37 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 2 | 4.24 doses per week | Standard Deviation 2.31 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 18 | 4.67 doses per week | Standard Deviation 2.42 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 4 | 3.89 doses per week | Standard Deviation 2.63 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 12 | 3.83 doses per week | Standard Deviation 2.41 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 13 | 4.45 doses per week | Standard Deviation 2.21 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 1 | 4.76 doses per week | Standard Deviation 1.68 |
| Tanezumab 20 mg | Number of Rescue Medication Doses Used Per Week | Week 11 | 4.08 doses per week | Standard Deviation 2.6 |
Secondary
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.
Time frame: Baseline, Week 2, 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 16 | 10.8 units on a scale | Standard Deviation 4.22 |
| Placebo | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 8 | 11.4 units on a scale | Standard Deviation 3.26 |
| Placebo | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline | 13.1 units on a scale | Standard Deviation 3.39 |
| Placebo | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 24 | 11.9 units on a scale | Standard Deviation 4.79 |
| Placebo | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 2 | 11.2 units on a scale | Standard Deviation 3.74 |
| Tanezumab 1 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 16 | 13.4 units on a scale | Standard Deviation 3.77 |
| Tanezumab 1 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 24 | 12.3 units on a scale | Standard Deviation 5.06 |
| Tanezumab 1 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline | 14.1 units on a scale | Standard Deviation 3.15 |
| Tanezumab 1 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 2 | 13.1 units on a scale | Standard Deviation 3.72 |
| Tanezumab 1 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 8 | 12.7 units on a scale | Standard Deviation 4.44 |
| Tanezumab 2.5 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 24 | 12.2 units on a scale | Standard Deviation 4.67 |
| Tanezumab 2.5 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline | 15.2 units on a scale | Standard Deviation 3.25 |
| Tanezumab 2.5 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 8 | 12.6 units on a scale | Standard Deviation 5.06 |
| Tanezumab 2.5 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 2 | 13.2 units on a scale | Standard Deviation 4.62 |
| Tanezumab 2.5 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 16 | 12.5 units on a scale | Standard Deviation 4.47 |
| Tanezumab 10 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 24 | 12.2 units on a scale | Standard Deviation 4.33 |
| Tanezumab 10 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline | 14.4 units on a scale | Standard Deviation 2.78 |
| Tanezumab 10 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 2 | 12.9 units on a scale | Standard Deviation 3.66 |
| Tanezumab 10 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 8 | 12.2 units on a scale | Standard Deviation 4.23 |
| Tanezumab 10 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 16 | 11.5 units on a scale | Standard Deviation 4.89 |
| Tanezumab 20 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 2 | 13.0 units on a scale | Standard Deviation 3.82 |
| Tanezumab 20 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 24 | 11.5 units on a scale | Standard Deviation 5.61 |
| Tanezumab 20 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 16 | 12.3 units on a scale | Standard Deviation 4.92 |
| Tanezumab 20 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Baseline | 14.5 units on a scale | Standard Deviation 2.72 |
| Tanezumab 20 mg | O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score | Week 8 | 12.2 units on a scale | Standard Deviation 4.7 |
Secondary
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.
Time frame: Baseline, Week 2, 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Baseline | 11.49 units on a scale | Standard Deviation 4.774 |
| Placebo | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 2 | 16.41 units on a scale | Standard Deviation 5.784 |
| Placebo | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 16 | 16.49 units on a scale | Standard Deviation 6.18 |
| Placebo | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 8 | 16.47 units on a scale | Standard Deviation 5.256 |
| Placebo | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 24 | 14.27 units on a scale | Standard Deviation 7.808 |
| Tanezumab 1 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Baseline | 10.56 units on a scale | Standard Deviation 4.147 |
| Tanezumab 1 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 24 | 14.45 units on a scale | Standard Deviation 5.663 |
| Tanezumab 1 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 2 | 12.79 units on a scale | Standard Deviation 5.173 |
| Tanezumab 1 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 8 | 12.02 units on a scale | Standard Deviation 5.594 |
| Tanezumab 1 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 16 | 11.19 units on a scale | Standard Deviation 4.486 |
| Tanezumab 2.5 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 24 | 16.77 units on a scale | Standard Deviation 8.044 |
| Tanezumab 2.5 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Baseline | 10.39 units on a scale | Standard Deviation 5.531 |
| Tanezumab 2.5 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 16 | 15.21 units on a scale | Standard Deviation 6.671 |
| Tanezumab 2.5 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 2 | 13.77 units on a scale | Standard Deviation 6.953 |
| Tanezumab 2.5 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 8 | 15.26 units on a scale | Standard Deviation 7.272 |
| Tanezumab 10 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 2 | 15.34 units on a scale | Standard Deviation 5.895 |
| Tanezumab 10 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 24 | 14.27 units on a scale | Standard Deviation 5.813 |
| Tanezumab 10 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 16 | 17.23 units on a scale | Standard Deviation 5.868 |
| Tanezumab 10 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 8 | 14.42 units on a scale | Standard Deviation 6.635 |
| Tanezumab 10 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Baseline | 11.44 units on a scale | Standard Deviation 3.938 |
| Tanezumab 20 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 24 | 15.05 units on a scale | Standard Deviation 6.852 |
| Tanezumab 20 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Baseline | 10.42 units on a scale | Standard Deviation 5.172 |
| Tanezumab 20 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 2 | 13.24 units on a scale | Standard Deviation 6.093 |
| Tanezumab 20 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 16 | 13.94 units on a scale | Standard Deviation 7.153 |
| Tanezumab 20 mg | Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score | Week 8 | 14.10 units on a scale | Standard Deviation 6.606 |
Secondary
Participant's Urge to Urinate
Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Participant's Urge to Urinate | Baseline | 15.63 units on a scale | Standard Deviation 4.313 |
| Placebo | Participant's Urge to Urinate | Week 24 | 12.39 units on a scale | Standard Deviation 7.258 |
| Placebo | Participant's Urge to Urinate | Week 20 | 14.05 units on a scale | Standard Deviation 5.729 |
| Placebo | Participant's Urge to Urinate | Week 8 | 14.81 units on a scale | Standard Deviation 4.951 |
| Placebo | Participant's Urge to Urinate | Week 4 | 13.75 units on a scale | Standard Deviation 5.871 |
| Placebo | Participant's Urge to Urinate | Week 12 | 13.21 units on a scale | Standard Deviation 6.01 |
| Placebo | Participant's Urge to Urinate | Week 16 | 13.59 units on a scale | Standard Deviation 5.589 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Week 16 | 14.28 units on a scale | Standard Deviation 6.083 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Week 12 | 15.64 units on a scale | Standard Deviation 6.904 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Week 4 | 16.27 units on a scale | Standard Deviation 5.99 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Baseline | 17.04 units on a scale | Standard Deviation 5.015 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Week 20 | 12.75 units on a scale | Standard Deviation 7.124 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Week 8 | 15.80 units on a scale | Standard Deviation 6.338 |
| Tanezumab 1 mg | Participant's Urge to Urinate | Week 24 | 13.25 units on a scale | Standard Deviation 6.489 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Week 12 | 13.75 units on a scale | Standard Deviation 6.376 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Baseline | 18.95 units on a scale | Standard Deviation 4.75 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Week 4 | 14.87 units on a scale | Standard Deviation 5.75 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Week 8 | 14.71 units on a scale | Standard Deviation 6.297 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Week 16 | 13.49 units on a scale | Standard Deviation 6.223 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Week 20 | 11.95 units on a scale | Standard Deviation 7.226 |
| Tanezumab 2.5 mg | Participant's Urge to Urinate | Week 24 | 11.13 units on a scale | Standard Deviation 7.442 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Week 8 | 14.38 units on a scale | Standard Deviation 4.804 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Week 16 | 14.05 units on a scale | Standard Deviation 5.812 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Week 4 | 15.71 units on a scale | Standard Deviation 4.699 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Week 24 | 14.28 units on a scale | Standard Deviation 4.87 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Week 20 | 13.97 units on a scale | Standard Deviation 5.887 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Baseline | 17.73 units on a scale | Standard Deviation 3.794 |
| Tanezumab 10 mg | Participant's Urge to Urinate | Week 12 | 14.43 units on a scale | Standard Deviation 5.635 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Week 8 | 13.81 units on a scale | Standard Deviation 6.83 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Week 24 | 15.87 units on a scale | Standard Deviation 8.8 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Week 20 | 15.62 units on a scale | Standard Deviation 9.02 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Week 16 | 13.85 units on a scale | Standard Deviation 8.156 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Week 4 | 14.83 units on a scale | Standard Deviation 6.234 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Baseline | 17.11 units on a scale | Standard Deviation 5.011 |
| Tanezumab 20 mg | Participant's Urge to Urinate | Week 12 | 14.02 units on a scale | Standard Deviation 7.761 |
Secondary
Patient Global Assessment of Health Status Scores
Participants answered: Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today? Participants responded on a 5-point scale where 1 = very good and 5 = very poor.
Time frame: Baseline, Week 2, 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Patient Global Assessment of Health Status Scores | Week 16 | 2.7 units on a scale | Standard Deviation 0.73 |
| Placebo | Patient Global Assessment of Health Status Scores | Baseline | 3.1 units on a scale | Standard Deviation 0.58 |
| Placebo | Patient Global Assessment of Health Status Scores | Week 24 | 2.7 units on a scale | Standard Deviation 0.89 |
| Placebo | Patient Global Assessment of Health Status Scores | Week 2 | 2.7 units on a scale | Standard Deviation 0.79 |
| Placebo | Patient Global Assessment of Health Status Scores | Week 8 | 2.9 units on a scale | Standard Deviation 0.7 |
| Tanezumab 1 mg | Patient Global Assessment of Health Status Scores | Week 16 | 3.0 units on a scale | Standard Deviation 0.82 |
| Tanezumab 1 mg | Patient Global Assessment of Health Status Scores | Week 8 | 2.9 units on a scale | Standard Deviation 0.94 |
| Tanezumab 1 mg | Patient Global Assessment of Health Status Scores | Week 2 | 2.9 units on a scale | Standard Deviation 0.75 |
| Tanezumab 1 mg | Patient Global Assessment of Health Status Scores | Week 24 | 2.6 units on a scale | Standard Deviation 0.62 |
| Tanezumab 1 mg | Patient Global Assessment of Health Status Scores | Baseline | 3.1 units on a scale | Standard Deviation 0.66 |
| Tanezumab 2.5 mg | Patient Global Assessment of Health Status Scores | Week 8 | 2.9 units on a scale | Standard Deviation 0.93 |
| Tanezumab 2.5 mg | Patient Global Assessment of Health Status Scores | Baseline | 3.5 units on a scale | Standard Deviation 0.82 |
| Tanezumab 2.5 mg | Patient Global Assessment of Health Status Scores | Week 2 | 2.9 units on a scale | Standard Deviation 0.9 |
| Tanezumab 2.5 mg | Patient Global Assessment of Health Status Scores | Week 16 | 2.8 units on a scale | Standard Deviation 0.58 |
| Tanezumab 2.5 mg | Patient Global Assessment of Health Status Scores | Week 24 | 2.5 units on a scale | Standard Deviation 0.94 |
| Tanezumab 10 mg | Patient Global Assessment of Health Status Scores | Week 24 | 2.8 units on a scale | Standard Deviation 0.79 |
| Tanezumab 10 mg | Patient Global Assessment of Health Status Scores | Baseline | 3.1 units on a scale | Standard Deviation 0.61 |
| Tanezumab 10 mg | Patient Global Assessment of Health Status Scores | Week 16 | 2.7 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg | Patient Global Assessment of Health Status Scores | Week 8 | 2.9 units on a scale | Standard Deviation 0.83 |
| Tanezumab 10 mg | Patient Global Assessment of Health Status Scores | Week 2 | 3.0 units on a scale | Standard Deviation 0.77 |
| Tanezumab 20 mg | Patient Global Assessment of Health Status Scores | Week 8 | 2.9 units on a scale | Standard Deviation 0.9 |
| Tanezumab 20 mg | Patient Global Assessment of Health Status Scores | Week 16 | 2.8 units on a scale | Standard Deviation 0.8 |
| Tanezumab 20 mg | Patient Global Assessment of Health Status Scores | Baseline | 3.1 units on a scale | Standard Deviation 0.76 |
| Tanezumab 20 mg | Patient Global Assessment of Health Status Scores | Week 24 | 3.4 units on a scale | Standard Deviation 0.86 |
| Tanezumab 20 mg | Patient Global Assessment of Health Status Scores | Week 2 | 2.9 units on a scale | Standard Deviation 0.66 |
Secondary
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.
Time frame: Week 8, 16
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Missing values were imputed using baseline observation carried forward (BOCF) method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 30% Reduction | 35.7 percentage of participants |
| Placebo | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 50% Reduction | 21.4 percentage of participants |
| Placebo | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 30% Reduction | 33.3 percentage of participants |
| Placebo | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 50% Reduction | 19.0 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 30% Reduction | 26.8 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 50% Reduction | 17.1 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 50% Reduction | 14.6 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 30% Reduction | 31.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 50% Reduction | 24.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 50% Reduction | 24.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 30% Reduction | 35.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 30% Reduction | 35.1 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 30% Reduction | 35.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 50% Reduction | 25.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 50% Reduction | 15.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 30% Reduction | 27.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 50% Reduction | 20.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 16: At least 30% Reduction | 27.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 50% Reduction | 17.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score | Week 8: At least 30% Reduction | 35.0 percentage of participants |
Comparison: Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.259, 1.683]
Comparison: Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.387, 2.457]
Comparison: Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.392, 2.398]
Comparison: Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.392, 2.398]
Comparison: Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.202, 1.96]
Comparison: Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.411, 3.376]
Comparison: Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.438, 3.414]
Comparison: Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.259, 2.335]
Comparison: Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.37, 2.327]
Comparison: Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.427, 2.749]
Comparison: Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.295, 1.952]
Comparison: Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.295, 1.952]
Comparison: Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.285, 2.682]
Comparison: Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.466, 4.006]
Comparison: Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.235, 2.394]
Comparison: Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.95% CI: [0.356, 3.168]
Secondary
Percentage of Participants Who Received Rescue Medication
For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 10 | 35.7 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 19 | 21.4 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 5 | 33.3 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 13 | 31.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 4 | 33.3 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 17 | 21.4 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 3 | 35.7 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 6 | 35.7 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 2 | 50.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 22 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 18 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 16 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 7 | 38.1 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 21 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 24 | 14.3 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 15 | 28.6 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 1 | 42.9 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 8 | 35.7 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 14 | 31.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 11 | 31.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Baseline | 52.4 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 12 | 26.2 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 9 | 31.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 23 | 19.0 percentage of participants |
| Placebo | Percentage of Participants Who Received Rescue Medication | Week 20 | 14.3 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 18 | 17.1 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 16 | 14.6 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 4 | 53.7 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 10 | 34.1 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 14 | 24.4 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 11 | 26.8 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 23 | 12.2 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 13 | 24.4 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 2 | 53.7 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 12 | 24.4 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Baseline | 65.9 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 24 | 7.3 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 21 | 12.2 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 3 | 51.2 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 20 | 12.2 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 17 | 17.1 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 5 | 39.0 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 6 | 48.8 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 15 | 17.1 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 7 | 26.8 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 22 | 14.6 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 8 | 34.1 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 19 | 19.5 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 1 | 53.7 percentage of participants |
| Tanezumab 1 mg | Percentage of Participants Who Received Rescue Medication | Week 9 | 31.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 14 | 21.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 20 | 21.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 21 | 18.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 22 | 10.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 23 | 10.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 4 | 43.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 24 | 5.4 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 2 | 54.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Baseline | 56.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 5 | 40.5 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 6 | 37.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 7 | 37.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 8 | 35.1 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 9 | 37.8 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 1 | 48.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 10 | 29.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 11 | 29.7 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 12 | 24.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 13 | 24.3 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 15 | 27.0 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 16 | 18.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 17 | 18.9 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 18 | 16.2 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 3 | 48.6 percentage of participants |
| Tanezumab 2.5 mg | Percentage of Participants Who Received Rescue Medication | Week 19 | 13.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 9 | 30.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 14 | 25.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 8 | 30.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 7 | 35.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 6 | 42.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 19 | 17.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 15 | 22.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 21 | 20.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 16 | 25.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Baseline | 50.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 5 | 40.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 4 | 45.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 20 | 17.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 17 | 22.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 24 | 10.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 23 | 10.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 22 | 10.8 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 3 | 47.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 12 | 27.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 11 | 25.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 18 | 17.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 13 | 22.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 2 | 57.5 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 1 | 50.0 percentage of participants |
| Tanezumab 10 mg | Percentage of Participants Who Received Rescue Medication | Week 10 | 22.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 24 | 7.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 15 | 20.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Baseline | 57.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 1 | 42.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 2 | 42.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 3 | 40.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 4 | 45.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 5 | 45.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 6 | 32.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 7 | 37.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 8 | 35.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 9 | 30.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 10 | 30.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 11 | 32.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 12 | 30.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 13 | 27.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 14 | 32.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 16 | 17.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 17 | 22.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 18 | 15.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 19 | 17.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 20 | 15.0 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 21 | 7.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 22 | 7.5 percentage of participants |
| Tanezumab 20 mg | Percentage of Participants Who Received Rescue Medication | Week 23 | 7.5 percentage of participants |
Secondary
Serum Total Nerve Growth Factor (NGF) Levels
Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.
Time frame: Baseline, Week 1, 2, 8, 16, 24
Population: ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Total Nerve Growth Factor (NGF) Levels | Baseline | 41.756 picogram per milliliter (pg/mL) | Standard Deviation 11.5576 |
| Placebo | Serum Total Nerve Growth Factor (NGF) Levels | Week 1 | 39.260 picogram per milliliter (pg/mL) | Standard Deviation 13.251 |
| Placebo | Serum Total Nerve Growth Factor (NGF) Levels | Week 2 | 40.162 picogram per milliliter (pg/mL) | Standard Deviation 10.1141 |
| Placebo | Serum Total Nerve Growth Factor (NGF) Levels | Week 8 | 58.075 picogram per milliliter (pg/mL) | Standard Deviation 103.6542 |
| Placebo | Serum Total Nerve Growth Factor (NGF) Levels | Week 16 | 48.207 picogram per milliliter (pg/mL) | Standard Deviation 28.6793 |
| Placebo | Serum Total Nerve Growth Factor (NGF) Levels | Week 24 | 40.626 picogram per milliliter (pg/mL) | Standard Deviation 8.9706 |
| Tanezumab 1 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 16 | 590.896 picogram per milliliter (pg/mL) | Standard Deviation 638.2373 |
| Tanezumab 1 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 24 | 131.474 picogram per milliliter (pg/mL) | Standard Deviation 123.8849 |
| Tanezumab 1 mg | Serum Total Nerve Growth Factor (NGF) Levels | Baseline | 39.929 picogram per milliliter (pg/mL) | Standard Deviation 10.7855 |
| Tanezumab 1 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 2 | 901.633 picogram per milliliter (pg/mL) | Standard Deviation 335.4488 |
| Tanezumab 1 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 8 | 841.984 picogram per milliliter (pg/mL) | Standard Deviation 446.1437 |
| Tanezumab 1 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 1 | 552.485 picogram per milliliter (pg/mL) | Standard Deviation 221.4202 |
| Tanezumab 2.5 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 8 | 1545.148 picogram per milliliter (pg/mL) | Standard Deviation 770.2641 |
| Tanezumab 2.5 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 16 | 1079.050 picogram per milliliter (pg/mL) | Standard Deviation 803.0958 |
| Tanezumab 2.5 mg | Serum Total Nerve Growth Factor (NGF) Levels | Baseline | 37.209 picogram per milliliter (pg/mL) | Standard Deviation 8.4699 |
| Tanezumab 2.5 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 2 | 1242.388 picogram per milliliter (pg/mL) | Standard Deviation 425.2031 |
| Tanezumab 2.5 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 1 | 730.917 picogram per milliliter (pg/mL) | Standard Deviation 253.8217 |
| Tanezumab 2.5 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 24 | 321.928 picogram per milliliter (pg/mL) | Standard Deviation 331.1179 |
| Tanezumab 10 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 8 | 2502.127 picogram per milliliter (pg/mL) | Standard Deviation 833.8403 |
| Tanezumab 10 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 1 | 1034.317 picogram per milliliter (pg/mL) | Standard Deviation 221.8687 |
| Tanezumab 10 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 2 | 1644.283 picogram per milliliter (pg/mL) | Standard Deviation 396.6413 |
| Tanezumab 10 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 24 | 2153.000 picogram per milliliter (pg/mL) | Standard Deviation 929.5347 |
| Tanezumab 10 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 16 | 3171.980 picogram per milliliter (pg/mL) | Standard Deviation 1205.2251 |
| Tanezumab 10 mg | Serum Total Nerve Growth Factor (NGF) Levels | Baseline | 38.381 picogram per milliliter (pg/mL) | Standard Deviation 11.0441 |
| Tanezumab 20 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 16 | 3497.462 picogram per milliliter (pg/mL) | Standard Deviation 2837.0678 |
| Tanezumab 20 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 2 | 1812.559 picogram per milliliter (pg/mL) | Standard Deviation 530.0335 |
| Tanezumab 20 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 1 | 1113.780 picogram per milliliter (pg/mL) | Standard Deviation 307.0217 |
| Tanezumab 20 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 24 | 3137.829 picogram per milliliter (pg/mL) | Standard Deviation 3612.2725 |
| Tanezumab 20 mg | Serum Total Nerve Growth Factor (NGF) Levels | Week 8 | 3369.039 picogram per milliliter (pg/mL) | Standard Deviation 1795.1505 |
| Tanezumab 20 mg | Serum Total Nerve Growth Factor (NGF) Levels | Baseline | 38.150 picogram per milliliter (pg/mL) | Standard Deviation 7.6355 |
Other Pre-specified
Body Temperature
Time frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Body Temperature | Week 1 | 36.57 degree Celsius | Standard Deviation 0.338 |
| Placebo | Body Temperature | Week 8 (1 hour post-dose) | 36.57 degree Celsius | Standard Deviation 0.307 |
| Placebo | Body Temperature | Day 1 (1 hour post-dose) | 36.46 degree Celsius | Standard Deviation 0.306 |
| Placebo | Body Temperature | Day 1 (1 hour pre-dose) | 36.56 degree Celsius | Standard Deviation 0.359 |
| Placebo | Body Temperature | Week 24 | 36.60 degree Celsius | Standard Deviation 0.387 |
| Placebo | Body Temperature | Week 16 | 36.53 degree Celsius | Standard Deviation 0.353 |
| Placebo | Body Temperature | Week 8 (1 hour pre-dose) | 36.56 degree Celsius | Standard Deviation 0.321 |
| Placebo | Body Temperature | Screening | 36.56 degree Celsius | Standard Deviation 0.323 |
| Placebo | Body Temperature | Week 2 | 36.56 degree Celsius | Standard Deviation 0.397 |
| Tanezumab 1 mg | Body Temperature | Week 16 | 36.66 degree Celsius | Standard Deviation 0.398 |
| Tanezumab 1 mg | Body Temperature | Week 24 | 36.63 degree Celsius | Standard Deviation 0.411 |
| Tanezumab 1 mg | Body Temperature | Screening | 36.71 degree Celsius | Standard Deviation 0.304 |
| Tanezumab 1 mg | Body Temperature | Day 1 (1 hour post-dose) | 36.55 degree Celsius | Standard Deviation 0.372 |
| Tanezumab 1 mg | Body Temperature | Week 1 | 36.67 degree Celsius | Standard Deviation 0.351 |
| Tanezumab 1 mg | Body Temperature | Week 2 | 36.57 degree Celsius | Standard Deviation 0.401 |
| Tanezumab 1 mg | Body Temperature | Week 8 (1 hour pre-dose) | 36.59 degree Celsius | Standard Deviation 0.285 |
| Tanezumab 1 mg | Body Temperature | Week 8 (1 hour post-dose) | 36.63 degree Celsius | Standard Deviation 0.301 |
| Tanezumab 1 mg | Body Temperature | Day 1 (1 hour pre-dose) | 36.62 degree Celsius | Standard Deviation 0.327 |
| Tanezumab 2.5 mg | Body Temperature | Week 1 | 36.52 degree Celsius | Standard Deviation 0.349 |
| Tanezumab 2.5 mg | Body Temperature | Week 16 | 36.64 degree Celsius | Standard Deviation 0.341 |
| Tanezumab 2.5 mg | Body Temperature | Week 2 | 36.55 degree Celsius | Standard Deviation 0.376 |
| Tanezumab 2.5 mg | Body Temperature | Week 24 | 36.53 degree Celsius | Standard Deviation 0.368 |
| Tanezumab 2.5 mg | Body Temperature | Week 8 (1 hour post-dose) | 36.60 degree Celsius | Standard Deviation 0.35 |
| Tanezumab 2.5 mg | Body Temperature | Week 8 (1 hour pre-dose) | 36.66 degree Celsius | Standard Deviation 0.342 |
| Tanezumab 2.5 mg | Body Temperature | Day 1 (1 hour pre-dose) | 36.64 degree Celsius | Standard Deviation 0.321 |
| Tanezumab 2.5 mg | Body Temperature | Day 1 (1 hour post-dose) | 36.65 degree Celsius | Standard Deviation 0.304 |
| Tanezumab 2.5 mg | Body Temperature | Screening | 36.56 degree Celsius | Standard Deviation 0.363 |
| Tanezumab 10 mg | Body Temperature | Day 1 (1 hour pre-dose) | 36.55 degree Celsius | Standard Deviation 0.362 |
| Tanezumab 10 mg | Body Temperature | Week 1 | 36.58 degree Celsius | Standard Deviation 0.317 |
| Tanezumab 10 mg | Body Temperature | Screening | 36.58 degree Celsius | Standard Deviation 0.341 |
| Tanezumab 10 mg | Body Temperature | Week 8 (1 hour post-dose) | 36.45 degree Celsius | Standard Deviation 0.244 |
| Tanezumab 10 mg | Body Temperature | Day 1 (1 hour post-dose) | 36.50 degree Celsius | Standard Deviation 0.364 |
| Tanezumab 10 mg | Body Temperature | Week 8 (1 hour pre-dose) | 36.58 degree Celsius | Standard Deviation 0.339 |
| Tanezumab 10 mg | Body Temperature | Week 2 | 36.63 degree Celsius | Standard Deviation 0.36 |
| Tanezumab 10 mg | Body Temperature | Week 24 | 36.53 degree Celsius | Standard Deviation 0.325 |
| Tanezumab 10 mg | Body Temperature | Week 16 | 36.37 degree Celsius | Standard Deviation 0.299 |
| Tanezumab 20 mg | Body Temperature | Week 24 | 36.60 degree Celsius | Standard Deviation 0.3 |
| Tanezumab 20 mg | Body Temperature | Screening | 36.67 degree Celsius | Standard Deviation 0.328 |
| Tanezumab 20 mg | Body Temperature | Day 1 (1 hour pre-dose) | 36.57 degree Celsius | Standard Deviation 0.246 |
| Tanezumab 20 mg | Body Temperature | Day 1 (1 hour post-dose) | 36.58 degree Celsius | Standard Deviation 0.322 |
| Tanezumab 20 mg | Body Temperature | Week 1 | 36.48 degree Celsius | Standard Deviation 0.351 |
| Tanezumab 20 mg | Body Temperature | Week 2 | 36.54 degree Celsius | Standard Deviation 0.294 |
| Tanezumab 20 mg | Body Temperature | Week 8 (1 hour pre-dose) | 36.60 degree Celsius | Standard Deviation 0.35 |
| Tanezumab 20 mg | Body Temperature | Week 8 (1 hour post-dose) | 36.66 degree Celsius | Standard Deviation 0.305 |
| Tanezumab 20 mg | Body Temperature | Week 16 | 36.71 degree Celsius | Standard Deviation 0.251 |
Other Pre-specified
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.
Time frame: Baseline, Week 2, 8, 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 16 | -0.1 units on a scale | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Baseline | 1.0 units on a scale | Standard Deviation 3.46 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 24 | -0.4 units on a scale | Standard Deviation 1.75 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 2 | -0.7 units on a scale | Standard Deviation 3.45 |
| Placebo | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 8 | -0.5 units on a scale | Standard Deviation 3.53 |
| Tanezumab 1 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 16 | -0.3 units on a scale | Standard Deviation 0.66 |
| Tanezumab 1 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 8 | 0.3 units on a scale | Standard Deviation 1.38 |
| Tanezumab 1 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 2 | 0.2 units on a scale | Standard Deviation 0.86 |
| Tanezumab 1 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 24 | -0.1 units on a scale | Standard Deviation 0.63 |
| Tanezumab 1 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Baseline | 0.4 units on a scale | Standard Deviation 0.92 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 8 | -0.1 units on a scale | Standard Deviation 0.47 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Baseline | 0.9 units on a scale | Standard Deviation 3.1 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 2 | 0.2 units on a scale | Standard Deviation 1.32 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 16 | 0.3 units on a scale | Standard Deviation 1.16 |
| Tanezumab 2.5 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 24 | -0.6 units on a scale | Standard Deviation 1.74 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 24 | 0.7 units on a scale | Standard Deviation 5.15 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Baseline | 0.9 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 16 | 1.4 units on a scale | Standard Deviation 6.33 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 8 | 1.1 units on a scale | Standard Deviation 5.28 |
| Tanezumab 10 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 2 | 0.9 units on a scale | Standard Deviation 2.88 |
| Tanezumab 20 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 8 | 0.0 units on a scale | Standard Deviation 0.41 |
| Tanezumab 20 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 16 | 0.1 units on a scale | Standard Deviation 0.23 |
| Tanezumab 20 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Baseline | 0.3 units on a scale | Standard Deviation 0.84 |
| Tanezumab 20 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 24 | 0.1 units on a scale | Standard Deviation 0.37 |
| Tanezumab 20 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24 | Change at Week 2 | -0.0 units on a scale | Standard Deviation 0.16 |
Other Pre-specified
Electrocardiogram Parameter: Heart Rate
Time frame: Screening, Day 1, Week 2, 8, 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Electrocardiogram Parameter: Heart Rate | Day 1 | 72.4 beats per minute | Standard Deviation 12.41 |
| Placebo | Electrocardiogram Parameter: Heart Rate | Screening | 71.1 beats per minute | Standard Deviation 12.18 |
| Placebo | Electrocardiogram Parameter: Heart Rate | Week 2 | 73.9 beats per minute | Standard Deviation 12.46 |
| Placebo | Electrocardiogram Parameter: Heart Rate | Week 8 | 72.3 beats per minute | Standard Deviation 11.47 |
| Placebo | Electrocardiogram Parameter: Heart Rate | Week 16 | 73.8 beats per minute | Standard Deviation 9.77 |
| Placebo | Electrocardiogram Parameter: Heart Rate | Week 24 | 71.9 beats per minute | Standard Deviation 9.81 |
| Tanezumab 1 mg | Electrocardiogram Parameter: Heart Rate | Week 24 | 72.4 beats per minute | Standard Deviation 11.98 |
| Tanezumab 1 mg | Electrocardiogram Parameter: Heart Rate | Week 16 | 72.9 beats per minute | Standard Deviation 12.76 |
| Tanezumab 1 mg | Electrocardiogram Parameter: Heart Rate | Screening | 71.2 beats per minute | Standard Deviation 10.77 |
| Tanezumab 1 mg | Electrocardiogram Parameter: Heart Rate | Day 1 | 72.5 beats per minute | Standard Deviation 11.34 |
| Tanezumab 1 mg | Electrocardiogram Parameter: Heart Rate | Week 8 | 72.8 beats per minute | Standard Deviation 11.66 |
| Tanezumab 1 mg | Electrocardiogram Parameter: Heart Rate | Week 2 | 74.1 beats per minute | Standard Deviation 10.38 |
| Tanezumab 2.5 mg | Electrocardiogram Parameter: Heart Rate | Week 8 | 71.7 beats per minute | Standard Deviation 10.93 |
| Tanezumab 2.5 mg | Electrocardiogram Parameter: Heart Rate | Week 16 | 75.9 beats per minute | Standard Deviation 8.69 |
| Tanezumab 2.5 mg | Electrocardiogram Parameter: Heart Rate | Week 2 | 71.5 beats per minute | Standard Deviation 10.94 |
| Tanezumab 2.5 mg | Electrocardiogram Parameter: Heart Rate | Day 1 | 72.3 beats per minute | Standard Deviation 11.58 |
| Tanezumab 2.5 mg | Electrocardiogram Parameter: Heart Rate | Week 24 | 74.7 beats per minute | Standard Deviation 11.55 |
| Tanezumab 2.5 mg | Electrocardiogram Parameter: Heart Rate | Screening | 72.4 beats per minute | Standard Deviation 11.49 |
| Tanezumab 10 mg | Electrocardiogram Parameter: Heart Rate | Screening | 71.3 beats per minute | Standard Deviation 14.47 |
| Tanezumab 10 mg | Electrocardiogram Parameter: Heart Rate | Day 1 | 70.7 beats per minute | Standard Deviation 14.36 |
| Tanezumab 10 mg | Electrocardiogram Parameter: Heart Rate | Week 2 | 72.0 beats per minute | Standard Deviation 13.98 |
| Tanezumab 10 mg | Electrocardiogram Parameter: Heart Rate | Week 8 | 68.4 beats per minute | Standard Deviation 15.47 |
| Tanezumab 10 mg | Electrocardiogram Parameter: Heart Rate | Week 24 | 69.3 beats per minute | Standard Deviation 13.12 |
| Tanezumab 10 mg | Electrocardiogram Parameter: Heart Rate | Week 16 | 68.3 beats per minute | Standard Deviation 15.39 |
| Tanezumab 20 mg | Electrocardiogram Parameter: Heart Rate | Week 16 | 72.2 beats per minute | Standard Deviation 14.41 |
| Tanezumab 20 mg | Electrocardiogram Parameter: Heart Rate | Week 8 | 69.9 beats per minute | Standard Deviation 12.56 |
| Tanezumab 20 mg | Electrocardiogram Parameter: Heart Rate | Week 24 | 71.5 beats per minute | Standard Deviation 9.09 |
| Tanezumab 20 mg | Electrocardiogram Parameter: Heart Rate | Week 2 | 73.8 beats per minute | Standard Deviation 11.68 |
| Tanezumab 20 mg | Electrocardiogram Parameter: Heart Rate | Day 1 | 73.2 beats per minute | Standard Deviation 11.06 |
| Tanezumab 20 mg | Electrocardiogram Parameter: Heart Rate | Screening | 71.4 beats per minute | Standard Deviation 12.42 |
Other Pre-specified
Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB).
Time frame: Screening, Day 1, Week 2, 8, 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcB Interval | 422.6 millisecond (msec) | Standard Deviation 23.99 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcB Interval | 419.8 millisecond (msec) | Standard Deviation 21.38 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcF Interval | 407.8 millisecond (msec) | Standard Deviation 19.36 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcB Interval | 426.8 millisecond (msec) | Standard Deviation 20.63 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: RR Interval | 825.7 millisecond (msec) | Standard Deviation 109.43 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: PR Interval | 152.1 millisecond (msec) | Standard Deviation 24.39 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcF Interval | 409.3 millisecond (msec) | Standard Deviation 19.44 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QRS Complex | 90.1 millisecond (msec) | Standard Deviation 7.69 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QT Interval | 386.6 millisecond (msec) | Standard Deviation 25.9 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: PR Interval | 155.1 millisecond (msec) | Standard Deviation 22.47 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcB Interval | 418.7 millisecond (msec) | Standard Deviation 19.71 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: RR Interval | 852.3 millisecond (msec) | Standard Deviation 149.92 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: PR Interval | 153.9 millisecond (msec) | Standard Deviation 20.71 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QRS Complex | 87.6 millisecond (msec) | Standard Deviation 8.43 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QT Interval | 384.7 millisecond (msec) | Standard Deviation 28.57 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QT Interval | 391.4 millisecond (msec) | Standard Deviation 31.92 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcB Interval | 425.6 millisecond (msec) | Standard Deviation 21.2 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QRS Complex | 90.2 millisecond (msec) | Standard Deviation 7.23 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcF Interval | 413.6 millisecond (msec) | Standard Deviation 19.16 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QRS Complex | 89.2 millisecond (msec) | Standard Deviation 7.68 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: RR Interval | 835.3 millisecond (msec) | Standard Deviation 140.48 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: PR Interval | 151.1 millisecond (msec) | Standard Deviation 21.46 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QRS Complex | 88.5 millisecond (msec) | Standard Deviation 8.81 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcF Interval | 406.8 millisecond (msec) | Standard Deviation 19.45 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: PR Interval | 155.4 millisecond (msec) | Standard Deviation 20.29 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QT Interval | 382.6 millisecond (msec) | Standard Deviation 27.92 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QT Interval | 389.1 millisecond (msec) | Standard Deviation 26.58 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcF Interval | 408.6 millisecond (msec) | Standard Deviation 19.88 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: RR Interval | 849.1 millisecond (msec) | Standard Deviation 116.7 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: RR Interval | 849.6 millisecond (msec) | Standard Deviation 134 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: RR Interval | 868.9 millisecond (msec) | Standard Deviation 152.1 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: PR Interval | 153.4 millisecond (msec) | Standard Deviation 20.12 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QRS Complex | 87.4 millisecond (msec) | Standard Deviation 9.88 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcB Interval | 420.2 millisecond (msec) | Standard Deviation 24.73 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcF Interval | 412.8 millisecond (msec) | Standard Deviation 18.96 |
| Placebo | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QT Interval | 385.8 millisecond (msec) | Standard Deviation 29.34 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QRS Complex | 89.6 millisecond (msec) | Standard Deviation 12.5 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcB Interval | 418.0 millisecond (msec) | Standard Deviation 20.17 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: RR Interval | 863.3 millisecond (msec) | Standard Deviation 138.89 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QT Interval | 386.4 millisecond (msec) | Standard Deviation 34.67 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcB Interval | 414.7 millisecond (msec) | Standard Deviation 16.98 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QRS Complex | 87.2 millisecond (msec) | Standard Deviation 11.48 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcF Interval | 404.8 millisecond (msec) | Standard Deviation 17.65 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcB Interval | 418.0 millisecond (msec) | Standard Deviation 14.16 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcF Interval | 404.8 millisecond (msec) | Standard Deviation 19.19 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcF Interval | 402.5 millisecond (msec) | Standard Deviation 18.11 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcF Interval | 408.9 millisecond (msec) | Standard Deviation 20.89 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QRS Complex | 89.0 millisecond (msec) | Standard Deviation 11.62 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QT Interval | 379.8 millisecond (msec) | Standard Deviation 30.21 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: PR Interval | 158.6 millisecond (msec) | Standard Deviation 19.44 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: RR Interval | 847.5 millisecond (msec) | Standard Deviation 138.15 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: RR Interval | 842.7 millisecond (msec) | Standard Deviation 121.9 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcB Interval | 418.7 millisecond (msec) | Standard Deviation 19.47 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: RR Interval | 825.1 millisecond (msec) | Standard Deviation 117.52 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QT Interval | 382.6 millisecond (msec) | Standard Deviation 30 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: PR Interval | 157.1 millisecond (msec) | Standard Deviation 17.66 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QT Interval | 382.1 millisecond (msec) | Standard Deviation 33.15 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: RR Interval | 850.6 millisecond (msec) | Standard Deviation 136.92 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QT Interval | 380.7 millisecond (msec) | Standard Deviation 35.74 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcF Interval | 407.3 millisecond (msec) | Standard Deviation 21.52 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QRS Complex | 89.3 millisecond (msec) | Standard Deviation 8.68 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QRS Complex | 90.2 millisecond (msec) | Standard Deviation 9.91 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcF Interval | 406.8 millisecond (msec) | Standard Deviation 18.29 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: PR Interval | 158.4 millisecond (msec) | Standard Deviation 20.83 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: PR Interval | 156.1 millisecond (msec) | Standard Deviation 17.76 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcB Interval | 416.9 millisecond (msec) | Standard Deviation 18.02 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcB Interval | 423.1 millisecond (msec) | Standard Deviation 21.21 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: PR Interval | 157.0 millisecond (msec) | Standard Deviation 17.56 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: RR Interval | 848.7 millisecond (msec) | Standard Deviation 137.85 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QRS Complex | 88.1 millisecond (msec) | Standard Deviation 11.59 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: PR Interval | 154.3 millisecond (msec) | Standard Deviation 19.6 |
| Tanezumab 1 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QT Interval | 386.0 millisecond (msec) | Standard Deviation 28.24 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QT Interval | 388.3 millisecond (msec) | Standard Deviation 27.18 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: PR Interval | 153.6 millisecond (msec) | Standard Deviation 22.14 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: PR Interval | 156.4 millisecond (msec) | Standard Deviation 20.83 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QRS Complex | 87.3 millisecond (msec) | Standard Deviation 8.34 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcB Interval | 427.7 millisecond (msec) | Standard Deviation 21.73 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QT Interval | 386.2 millisecond (msec) | Standard Deviation 27.28 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QRS Complex | 89.4 millisecond (msec) | Standard Deviation 8.1 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcF Interval | 410.6 millisecond (msec) | Standard Deviation 17.61 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcB Interval | 420.8 millisecond (msec) | Standard Deviation 20.52 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QT Interval | 389.1 millisecond (msec) | Standard Deviation 27.69 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcF Interval | 408.7 millisecond (msec) | Standard Deviation 18.27 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: RR Interval | 857.5 millisecond (msec) | Standard Deviation 123.18 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QRS Complex | 88.6 millisecond (msec) | Standard Deviation 8.33 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: PR Interval | 157.7 millisecond (msec) | Standard Deviation 21.18 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: RR Interval | 855.0 millisecond (msec) | Standard Deviation 126.13 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: PR Interval | 158.9 millisecond (msec) | Standard Deviation 21.31 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: RR Interval | 849.6 millisecond (msec) | Standard Deviation 136.23 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcB Interval | 427.6 millisecond (msec) | Standard Deviation 25.18 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QRS Complex | 89.6 millisecond (msec) | Standard Deviation 9.51 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcB Interval | 421.1 millisecond (msec) | Standard Deviation 24.04 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcB Interval | 424.2 millisecond (msec) | Standard Deviation 22.27 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcF Interval | 411.4 millisecond (msec) | Standard Deviation 22.01 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcF Interval | 409.2 millisecond (msec) | Standard Deviation 18.95 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcF Interval | 413.9 millisecond (msec) | Standard Deviation 20.07 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QRS Complex | 89.4 millisecond (msec) | Standard Deviation 9.69 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: RR Interval | 799.6 millisecond (msec) | Standard Deviation 87.02 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QT Interval | 381.3 millisecond (msec) | Standard Deviation 23.89 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: PR Interval | 155.2 millisecond (msec) | Standard Deviation 18.75 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QT Interval | 389.5 millisecond (msec) | Standard Deviation 29.46 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: PR Interval | 157.0 millisecond (msec) | Standard Deviation 22.2 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QRS Complex | 90.8 millisecond (msec) | Standard Deviation 8.85 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: RR Interval | 821.8 millisecond (msec) | Standard Deviation 122.24 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcF Interval | 411.9 millisecond (msec) | Standard Deviation 19.1 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QT Interval | 387.3 millisecond (msec) | Standard Deviation 21.8 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcB Interval | 422.1 millisecond (msec) | Standard Deviation 17.73 |
| Tanezumab 2.5 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: RR Interval | 849.4 millisecond (msec) | Standard Deviation 126.73 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcF Interval | 410.8 millisecond (msec) | Standard Deviation 20.48 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: RR Interval | 878.5 millisecond (msec) | Standard Deviation 189.33 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: PR Interval | 154.8 millisecond (msec) | Standard Deviation 24.53 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QRS Complex | 87.5 millisecond (msec) | Standard Deviation 9.17 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QT Interval | 390.5 millisecond (msec) | Standard Deviation 37.31 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcB Interval | 416.8 millisecond (msec) | Standard Deviation 22.81 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcF Interval | 407.3 millisecond (msec) | Standard Deviation 21.13 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: RR Interval | 883.4 millisecond (msec) | Standard Deviation 183.93 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: PR Interval | 153.2 millisecond (msec) | Standard Deviation 23.98 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QRS Complex | 87.4 millisecond (msec) | Standard Deviation 10.46 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QT Interval | 392.5 millisecond (msec) | Standard Deviation 33.74 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcB Interval | 418.9 millisecond (msec) | Standard Deviation 18.21 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcF Interval | 409.5 millisecond (msec) | Standard Deviation 15.95 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: RR Interval | 867.4 millisecond (msec) | Standard Deviation 191.34 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: PR Interval | 152.7 millisecond (msec) | Standard Deviation 24 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QRS Complex | 88.5 millisecond (msec) | Standard Deviation 8.5 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QT Interval | 386.4 millisecond (msec) | Standard Deviation 36.77 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcB Interval | 418.1 millisecond (msec) | Standard Deviation 20.29 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcF Interval | 406.7 millisecond (msec) | Standard Deviation 18.85 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: RR Interval | 919.6 millisecond (msec) | Standard Deviation 199.85 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: PR Interval | 154.3 millisecond (msec) | Standard Deviation 25.04 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QRS Complex | 88.7 millisecond (msec) | Standard Deviation 10.52 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QT Interval | 401.5 millisecond (msec) | Standard Deviation 40.44 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcB Interval | 419.3 millisecond (msec) | Standard Deviation 16.86 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcF Interval | 412.8 millisecond (msec) | Standard Deviation 18.3 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: RR Interval | 925.9 millisecond (msec) | Standard Deviation 224.34 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: PR Interval | 156.6 millisecond (msec) | Standard Deviation 26.49 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QRS Complex | 89.2 millisecond (msec) | Standard Deviation 8.79 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QT Interval | 403.9 millisecond (msec) | Standard Deviation 37.73 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcB Interval | 421.6 millisecond (msec) | Standard Deviation 21.94 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcF Interval | 414.9 millisecond (msec) | Standard Deviation 17.4 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: RR Interval | 894.9 millisecond (msec) | Standard Deviation 164.8 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: PR Interval | 158.9 millisecond (msec) | Standard Deviation 23.25 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QRS Complex | 88.9 millisecond (msec) | Standard Deviation 8.56 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QT Interval | 395.0 millisecond (msec) | Standard Deviation 33.83 |
| Tanezumab 10 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcB Interval | 419.5 millisecond (msec) | Standard Deviation 23.12 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QT Interval | 384.0 millisecond (msec) | Standard Deviation 29.36 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcB Interval | 418.7 millisecond (msec) | Standard Deviation 24.51 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QRS Complex | 90.5 millisecond (msec) | Standard Deviation 7.8 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: PR Interval | 156.8 millisecond (msec) | Standard Deviation 29.74 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: RR Interval | 882.8 millisecond (msec) | Standard Deviation 152.53 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcF Interval | 406.3 millisecond (msec) | Standard Deviation 18.21 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QTcF Interval | 406.9 millisecond (msec) | Standard Deviation 17.8 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcF Interval | 407.3 millisecond (msec) | Standard Deviation 15.44 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QTcB Interval | 420.9 millisecond (msec) | Standard Deviation 20.48 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QT Interval | 382.0 millisecond (msec) | Standard Deviation 23.45 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QTcB Interval | 418.4 millisecond (msec) | Standard Deviation 19.8 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: RR Interval | 851.2 millisecond (msec) | Standard Deviation 106.9 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: QRS Complex | 90.0 millisecond (msec) | Standard Deviation 7.07 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: PR Interval | 160.8 millisecond (msec) | Standard Deviation 28.15 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 2: RR Interval | 833.4 millisecond (msec) | Standard Deviation 134.21 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QRS Complex | 90.6 millisecond (msec) | Standard Deviation 6.82 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: PR Interval | 159.1 millisecond (msec) | Standard Deviation 27.92 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcF Interval | 406.0 millisecond (msec) | Standard Deviation 15.28 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QTcB Interval | 418.4 millisecond (msec) | Standard Deviation 17.21 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QT Interval | 382.8 millisecond (msec) | Standard Deviation 23.82 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: PR Interval | 158.6 millisecond (msec) | Standard Deviation 28.85 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QRS Complex | 89.4 millisecond (msec) | Standard Deviation 7.77 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: QRS Complex | 89.1 millisecond (msec) | Standard Deviation 8.13 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: PR Interval | 158.2 millisecond (msec) | Standard Deviation 34.39 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Day 1: RR Interval | 836.4 millisecond (msec) | Standard Deviation 117.33 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: RR Interval | 863.2 millisecond (msec) | Standard Deviation 143.31 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 24: QT Interval | 383.5 millisecond (msec) | Standard Deviation 24.31 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcF Interval | 404.3 millisecond (msec) | Standard Deviation 17.83 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QRS Complex | 90.4 millisecond (msec) | Standard Deviation 6.33 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: PR Interval | 150.5 millisecond (msec) | Standard Deviation 21.33 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: RR Interval | 865.4 millisecond (msec) | Standard Deviation 188.59 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Screening: QTcB Interval | 415.3 millisecond (msec) | Standard Deviation 19.71 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 16: QT Interval | 385.8 millisecond (msec) | Standard Deviation 30.81 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcF Interval | 410.0 millisecond (msec) | Standard Deviation 16.65 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QTcB Interval | 419.8 millisecond (msec) | Standard Deviation 20.18 |
| Tanezumab 20 mg | Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals | Week 8: QT Interval | 392.0 millisecond (msec) | Standard Deviation 28.49 |
Other Pre-specified
Heart Rate
Time frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate | Week 24 | 77.5 beats per minute | Standard Deviation 10.44 |
| Placebo | Heart Rate | Week 2 | 76.1 beats per minute | Standard Deviation 11.24 |
| Placebo | Heart Rate | Day 1 (1 hour pre-dose) | 75.4 beats per minute | Standard Deviation 10.45 |
| Placebo | Heart Rate | Week 8 (1 hour pre-dose) | 74.7 beats per minute | Standard Deviation 10.91 |
| Placebo | Heart Rate | Screening | 74.7 beats per minute | Standard Deviation 10.37 |
| Placebo | Heart Rate | Week 16 | 75.6 beats per minute | Standard Deviation 9.84 |
| Placebo | Heart Rate | Day 1 (1 hour post-dose) | 75.1 beats per minute | Standard Deviation 10.22 |
| Placebo | Heart Rate | Week 8 (1 hour post-dose) | 73.9 beats per minute | Standard Deviation 9.59 |
| Placebo | Heart Rate | Week 1 | 77.2 beats per minute | Standard Deviation 10.66 |
| Tanezumab 1 mg | Heart Rate | Week 1 | 79.4 beats per minute | Standard Deviation 11.07 |
| Tanezumab 1 mg | Heart Rate | Week 8 (1 hour pre-dose) | 77.4 beats per minute | Standard Deviation 14.51 |
| Tanezumab 1 mg | Heart Rate | Screening | 76.4 beats per minute | Standard Deviation 10.4 |
| Tanezumab 1 mg | Heart Rate | Week 2 | 77.1 beats per minute | Standard Deviation 10.36 |
| Tanezumab 1 mg | Heart Rate | Day 1 (1 hour post-dose) | 75.3 beats per minute | Standard Deviation 9.18 |
| Tanezumab 1 mg | Heart Rate | Week 24 | 79.9 beats per minute | Standard Deviation 11.68 |
| Tanezumab 1 mg | Heart Rate | Day 1 (1 hour pre-dose) | 77.5 beats per minute | Standard Deviation 10.86 |
| Tanezumab 1 mg | Heart Rate | Week 8 (1 hour post-dose) | 77.3 beats per minute | Standard Deviation 12.66 |
| Tanezumab 1 mg | Heart Rate | Week 16 | 75.0 beats per minute | Standard Deviation 11.54 |
| Tanezumab 2.5 mg | Heart Rate | Week 8 (1 hour pre-dose) | 71.1 beats per minute | Standard Deviation 10.43 |
| Tanezumab 2.5 mg | Heart Rate | Screening | 75.0 beats per minute | Standard Deviation 12.72 |
| Tanezumab 2.5 mg | Heart Rate | Day 1 (1 hour pre-dose) | 75.5 beats per minute | Standard Deviation 12.06 |
| Tanezumab 2.5 mg | Heart Rate | Day 1 (1 hour post-dose) | 74.8 beats per minute | Standard Deviation 12.3 |
| Tanezumab 2.5 mg | Heart Rate | Week 1 | 76.4 beats per minute | Standard Deviation 12.06 |
| Tanezumab 2.5 mg | Heart Rate | Week 2 | 75.8 beats per minute | Standard Deviation 10.92 |
| Tanezumab 2.5 mg | Heart Rate | Week 8 (1 hour post-dose) | 72.3 beats per minute | Standard Deviation 10.92 |
| Tanezumab 2.5 mg | Heart Rate | Week 16 | 75.9 beats per minute | Standard Deviation 11.95 |
| Tanezumab 2.5 mg | Heart Rate | Week 24 | 75.3 beats per minute | Standard Deviation 11.22 |
| Tanezumab 10 mg | Heart Rate | Week 1 | 72.4 beats per minute | Standard Deviation 14 |
| Tanezumab 10 mg | Heart Rate | Week 8 (1 hour pre-dose) | 71.4 beats per minute | Standard Deviation 15.02 |
| Tanezumab 10 mg | Heart Rate | Day 1 (1 hour post-dose) | 71.9 beats per minute | Standard Deviation 12.76 |
| Tanezumab 10 mg | Heart Rate | Week 8 (1 hour post-dose) | 69.2 beats per minute | Standard Deviation 15.58 |
| Tanezumab 10 mg | Heart Rate | Day 1 (1 hour pre-dose) | 73.6 beats per minute | Standard Deviation 14.03 |
| Tanezumab 10 mg | Heart Rate | Week 24 | 72.7 beats per minute | Standard Deviation 13.81 |
| Tanezumab 10 mg | Heart Rate | Week 16 | 70.9 beats per minute | Standard Deviation 15.77 |
| Tanezumab 10 mg | Heart Rate | Screening | 74.2 beats per minute | Standard Deviation 15.22 |
| Tanezumab 10 mg | Heart Rate | Week 2 | 74.0 beats per minute | Standard Deviation 14.22 |
| Tanezumab 20 mg | Heart Rate | Screening | 75.5 beats per minute | Standard Deviation 11.81 |
| Tanezumab 20 mg | Heart Rate | Week 1 | 80.1 beats per minute | Standard Deviation 12.74 |
| Tanezumab 20 mg | Heart Rate | Week 8 (1 hour pre-dose) | 75.1 beats per minute | Standard Deviation 11.34 |
| Tanezumab 20 mg | Heart Rate | Day 1 (1 hour post-dose) | 75.3 beats per minute | Standard Deviation 10.6 |
| Tanezumab 20 mg | Heart Rate | Week 2 | 77.8 beats per minute | Standard Deviation 11.37 |
| Tanezumab 20 mg | Heart Rate | Week 24 | 77.3 beats per minute | Standard Deviation 9.65 |
| Tanezumab 20 mg | Heart Rate | Week 16 | 75.6 beats per minute | Standard Deviation 13.6 |
| Tanezumab 20 mg | Heart Rate | Week 8 (1 hour post-dose) | 71.3 beats per minute | Standard Deviation 11.29 |
| Tanezumab 20 mg | Heart Rate | Day 1 (1 hour pre-dose) | 76.5 beats per minute | Standard Deviation 11.17 |
Other Pre-specified
Number of Participants With Anti-Drug Antibody (ADA)
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.
Time frame: Baseline, Week 8, 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-Drug Antibody (ADA) | Week 24 | 0 Participants |
| Placebo | Number of Participants With Anti-Drug Antibody (ADA) | Baseline | 0 Participants |
| Placebo | Number of Participants With Anti-Drug Antibody (ADA) | Week 8 | 0 Participants |
| Placebo | Number of Participants With Anti-Drug Antibody (ADA) | Week 16 | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 8 | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 16 | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Anti-Drug Antibody (ADA) | Baseline | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 24 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) | Baseline | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 8 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 16 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 24 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 24 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) | Baseline | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 8 | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Anti-Drug Antibody (ADA) | Week 16 | 0 Participants |
Other Pre-specified
Number of Participants With Laboratory Test Abnormalities
Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.
Time frame: Screening up to Week 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Laboratory Test Abnormalities | 28 Participants |
| Tanezumab 1 mg | Number of Participants With Laboratory Test Abnormalities | 21 Participants |
| Tanezumab 2.5 mg | Number of Participants With Laboratory Test Abnormalities | 24 Participants |
| Tanezumab 10 mg | Number of Participants With Laboratory Test Abnormalities | 24 Participants |
| Tanezumab 20 mg | Number of Participants With Laboratory Test Abnormalities | 25 Participants |
Other Pre-specified
Number of Participants With Neurological Examination Findings
A neurological examination assessed the 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 fingers and great toes.
Time frame: Week 2, 8, 16, Week 24 or early termination
Population: ITT analysis set. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Neurological Examination Findings | Week 2 | 1 Participants |
| Placebo | Number of Participants With Neurological Examination Findings | Week 8 | 2 Participants |
| Placebo | Number of Participants With Neurological Examination Findings | Week 16 | 0 Participants |
| Placebo | Number of Participants With Neurological Examination Findings | Week 24 or early termination | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Neurological Examination Findings | Week 2 | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Neurological Examination Findings | Week 24 or early termination | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Neurological Examination Findings | Week 8 | 2 Participants |
| Tanezumab 1 mg | Number of Participants With Neurological Examination Findings | Week 16 | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Neurological Examination Findings | Week 24 or early termination | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Neurological Examination Findings | Week 8 | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Neurological Examination Findings | Week 16 | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Neurological Examination Findings | Week 2 | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Neurological Examination Findings | Week 2 | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Neurological Examination Findings | Week 8 | 3 Participants |
| Tanezumab 10 mg | Number of Participants With Neurological Examination Findings | Week 24 or early termination | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Neurological Examination Findings | Week 16 | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Neurological Examination Findings | Week 24 or early termination | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Neurological Examination Findings | Week 16 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Neurological Examination Findings | Week 8 | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Neurological Examination Findings | Week 2 | 0 Participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time frame: Baseline up to 112 days after the last dose (up to Week 24)
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 24 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 30 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 6 Participants |
| Tanezumab 2.5 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 24 Participants |
| Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 29 Participants |
| Tanezumab 10 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 23 Participants |
Other Pre-specified
Number of Participants With Urinalysis Abnormalities
Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (\<1.003 and \>1.030), urine pH (\<4.5 and \>8), protein (\>=1 value in qualitative test), glucose (\>=1 value in qualitative test), ketones (\>=1 value in qualitative test), blood (\>=1 value in qualitative test), bilirubin (\>=1 value in qualitative test), nitrites (\>=1), and leukocyte esterase (\>=1) are reported.
Time frame: Screening up to Week 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Bilirubin | 1 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine pH | 1 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Leukocyte Esterase | 3 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Ketones | 1 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Blood | 10 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Protein | 3 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Nitrite | 1 Participants |
| Placebo | Number of Participants With Urinalysis Abnormalities | Urine Glucose | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Blood | 11 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Bilirubin | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Leukocyte Esterase | 4 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Glucose | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Ketones | 3 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Nitrite | 0 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine Protein | 1 Participants |
| Tanezumab 1 mg | Number of Participants With Urinalysis Abnormalities | Urine pH | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Bilirubin | 7 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Leukocyte Esterase | 3 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine pH | 0 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Protein | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Nitrite | 1 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Blood | 8 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Ketones | 2 Participants |
| Tanezumab 2.5 mg | Number of Participants With Urinalysis Abnormalities | Urine Glucose | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Glucose | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine pH | 1 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Ketones | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Protein | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Blood | 11 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Bilirubin | 5 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Nitrite | 0 Participants |
| Tanezumab 10 mg | Number of Participants With Urinalysis Abnormalities | Urine Leukocyte Esterase | 6 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Ketones | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Glucose | 1 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Leukocyte Esterase | 3 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Nitrite | 2 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Bilirubin | 4 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine pH | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Blood | 10 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Specific Gravity | 0 Participants |
| Tanezumab 20 mg | Number of Participants With Urinalysis Abnormalities | Urine Protein | 5 Participants |
Other Pre-specified
Post-void Residual (PVR) Volume
PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.
Time frame: Screening, Week 2, 8, 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Post-void Residual (PVR) Volume | Week 16 | 20.5 milliliter | Standard Deviation 37.61 |
| Placebo | Post-void Residual (PVR) Volume | Screening | 27.1 milliliter | Standard Deviation 31.44 |
| Placebo | Post-void Residual (PVR) Volume | Week 24 | 17.2 milliliter | Standard Deviation 25.05 |
| Placebo | Post-void Residual (PVR) Volume | Week 2 | 20.9 milliliter | Standard Deviation 30.43 |
| Placebo | Post-void Residual (PVR) Volume | Week 8 | 19.2 milliliter | Standard Deviation 24.37 |
| Tanezumab 1 mg | Post-void Residual (PVR) Volume | Week 16 | 10.9 milliliter | Standard Deviation 15.33 |
| Tanezumab 1 mg | Post-void Residual (PVR) Volume | Week 8 | 11.9 milliliter | Standard Deviation 21.47 |
| Tanezumab 1 mg | Post-void Residual (PVR) Volume | Week 2 | 11.6 milliliter | Standard Deviation 17.16 |
| Tanezumab 1 mg | Post-void Residual (PVR) Volume | Week 24 | 14.3 milliliter | Standard Deviation 24.27 |
| Tanezumab 1 mg | Post-void Residual (PVR) Volume | Screening | 22.3 milliliter | Standard Deviation 33.29 |
| Tanezumab 2.5 mg | Post-void Residual (PVR) Volume | Week 8 | 17.7 milliliter | Standard Deviation 21.36 |
| Tanezumab 2.5 mg | Post-void Residual (PVR) Volume | Screening | 24.8 milliliter | Standard Deviation 36.99 |
| Tanezumab 2.5 mg | Post-void Residual (PVR) Volume | Week 2 | 20.1 milliliter | Standard Deviation 34.58 |
| Tanezumab 2.5 mg | Post-void Residual (PVR) Volume | Week 16 | 27.3 milliliter | Standard Deviation 47.43 |
| Tanezumab 2.5 mg | Post-void Residual (PVR) Volume | Week 24 | 18.6 milliliter | Standard Deviation 33.84 |
| Tanezumab 10 mg | Post-void Residual (PVR) Volume | Week 24 | 16.8 milliliter | Standard Deviation 25.5 |
| Tanezumab 10 mg | Post-void Residual (PVR) Volume | Screening | 25.2 milliliter | Standard Deviation 27.1 |
| Tanezumab 10 mg | Post-void Residual (PVR) Volume | Week 16 | 25.7 milliliter | Standard Deviation 26.4 |
| Tanezumab 10 mg | Post-void Residual (PVR) Volume | Week 8 | 21.4 milliliter | Standard Deviation 32.82 |
| Tanezumab 10 mg | Post-void Residual (PVR) Volume | Week 2 | 20.7 milliliter | Standard Deviation 28.03 |
| Tanezumab 20 mg | Post-void Residual (PVR) Volume | Week 8 | 21.2 milliliter | Standard Deviation 29.39 |
| Tanezumab 20 mg | Post-void Residual (PVR) Volume | Week 16 | 23.9 milliliter | Standard Deviation 31.41 |
| Tanezumab 20 mg | Post-void Residual (PVR) Volume | Screening | 24.5 milliliter | Standard Deviation 35.56 |
| Tanezumab 20 mg | Post-void Residual (PVR) Volume | Week 24 | 17.6 milliliter | Standard Deviation 22.14 |
| Tanezumab 20 mg | Post-void Residual (PVR) Volume | Week 2 | 25.8 milliliter | Standard Deviation 39.61 |
Other Pre-specified
Respiratory Rate
Time frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Respiratory Rate | Week 1 | 16.3 respirations per minute | Standard Deviation 2.64 |
| Placebo | Respiratory Rate | Week 24 | 16.1 respirations per minute | Standard Deviation 2.67 |
| Placebo | Respiratory Rate | Week 8 (1 hour post-dose) | 16.2 respirations per minute | Standard Deviation 2.89 |
| Placebo | Respiratory Rate | Day 1 (1 hour post-dose) | 16.2 respirations per minute | Standard Deviation 2.64 |
| Placebo | Respiratory Rate | Screening | 16.2 respirations per minute | Standard Deviation 2.46 |
| Placebo | Respiratory Rate | Week 8 (1 hour pre-dose) | 15.8 respirations per minute | Standard Deviation 2.75 |
| Placebo | Respiratory Rate | Week 2 | 16.0 respirations per minute | Standard Deviation 2.49 |
| Placebo | Respiratory Rate | Day 1 (1 hour pre-dose) | 16.3 respirations per minute | Standard Deviation 2.62 |
| Placebo | Respiratory Rate | Week 16 | 16.0 respirations per minute | Standard Deviation 2 |
| Tanezumab 1 mg | Respiratory Rate | Week 8 (1 hour pre-dose) | 15.8 respirations per minute | Standard Deviation 2.19 |
| Tanezumab 1 mg | Respiratory Rate | Week 8 (1 hour post-dose) | 16.3 respirations per minute | Standard Deviation 2.18 |
| Tanezumab 1 mg | Respiratory Rate | Day 1 (1 hour pre-dose) | 16.2 respirations per minute | Standard Deviation 2.35 |
| Tanezumab 1 mg | Respiratory Rate | Week 24 | 15.6 respirations per minute | Standard Deviation 2.38 |
| Tanezumab 1 mg | Respiratory Rate | Day 1 (1 hour post-dose) | 16.3 respirations per minute | Standard Deviation 2.46 |
| Tanezumab 1 mg | Respiratory Rate | Screening | 15.8 respirations per minute | Standard Deviation 2.89 |
| Tanezumab 1 mg | Respiratory Rate | Week 1 | 16.3 respirations per minute | Standard Deviation 2.33 |
| Tanezumab 1 mg | Respiratory Rate | Week 2 | 16.4 respirations per minute | Standard Deviation 2.31 |
| Tanezumab 1 mg | Respiratory Rate | Week 16 | 16.9 respirations per minute | Standard Deviation 2.38 |
| Tanezumab 2.5 mg | Respiratory Rate | Week 8 (1 hour pre-dose) | 16.3 respirations per minute | Standard Deviation 2.25 |
| Tanezumab 2.5 mg | Respiratory Rate | Week 16 | 17.0 respirations per minute | Standard Deviation 2.24 |
| Tanezumab 2.5 mg | Respiratory Rate | Week 24 | 15.1 respirations per minute | Standard Deviation 2.4 |
| Tanezumab 2.5 mg | Respiratory Rate | Week 8 (1 hour post-dose) | 16.6 respirations per minute | Standard Deviation 1.87 |
| Tanezumab 2.5 mg | Respiratory Rate | Week 2 | 16.2 respirations per minute | Standard Deviation 2.29 |
| Tanezumab 2.5 mg | Respiratory Rate | Day 1 (1 hour post-dose) | 15.8 respirations per minute | Standard Deviation 2.42 |
| Tanezumab 2.5 mg | Respiratory Rate | Screening | 16.3 respirations per minute | Standard Deviation 1.74 |
| Tanezumab 2.5 mg | Respiratory Rate | Week 1 | 16.1 respirations per minute | Standard Deviation 2.08 |
| Tanezumab 2.5 mg | Respiratory Rate | Day 1 (1 hour pre-dose) | 15.9 respirations per minute | Standard Deviation 2.14 |
| Tanezumab 10 mg | Respiratory Rate | Day 1 (1 hour pre-dose) | 16.2 respirations per minute | Standard Deviation 2.97 |
| Tanezumab 10 mg | Respiratory Rate | Week 1 | 16.2 respirations per minute | Standard Deviation 2.99 |
| Tanezumab 10 mg | Respiratory Rate | Screening | 16.5 respirations per minute | Standard Deviation 2.83 |
| Tanezumab 10 mg | Respiratory Rate | Day 1 (1 hour post-dose) | 16.2 respirations per minute | Standard Deviation 3.04 |
| Tanezumab 10 mg | Respiratory Rate | Week 2 | 16.8 respirations per minute | Standard Deviation 2.77 |
| Tanezumab 10 mg | Respiratory Rate | Week 8 (1 hour pre-dose) | 15.9 respirations per minute | Standard Deviation 3.02 |
| Tanezumab 10 mg | Respiratory Rate | Week 8 (1 hour post-dose) | 16.4 respirations per minute | Standard Deviation 3 |
| Tanezumab 10 mg | Respiratory Rate | Week 16 | 16.2 respirations per minute | Standard Deviation 2.56 |
| Tanezumab 10 mg | Respiratory Rate | Week 24 | 16.0 respirations per minute | Standard Deviation 2.64 |
| Tanezumab 20 mg | Respiratory Rate | Week 2 | 16.2 respirations per minute | Standard Deviation 1.94 |
| Tanezumab 20 mg | Respiratory Rate | Week 1 | 15.7 respirations per minute | Standard Deviation 2.09 |
| Tanezumab 20 mg | Respiratory Rate | Week 24 | 15.8 respirations per minute | Standard Deviation 2.08 |
| Tanezumab 20 mg | Respiratory Rate | Week 16 | 16.0 respirations per minute | Standard Deviation 1.67 |
| Tanezumab 20 mg | Respiratory Rate | Day 1 (1 hour post-dose) | 15.8 respirations per minute | Standard Deviation 1.98 |
| Tanezumab 20 mg | Respiratory Rate | Day 1 (1 hour pre-dose) | 15.9 respirations per minute | Standard Deviation 1.83 |
| Tanezumab 20 mg | Respiratory Rate | Screening | 16.1 respirations per minute | Standard Deviation 1.75 |
| Tanezumab 20 mg | Respiratory Rate | Week 8 (1 hour post-dose) | 16.0 respirations per minute | Standard Deviation 1.54 |
| Tanezumab 20 mg | Respiratory Rate | Week 8 (1 hour pre-dose) | 16.1 respirations per minute | Standard Deviation 1.88 |
Other Pre-specified
Systolic and Diastolic Blood Pressure
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.
Time frame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
Population: Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Systolic and Diastolic Blood Pressure | Week 1: SBP | 124.6 millimeter of mercury (mmHg) | Standard Deviation 17.29 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 24: SBP | 124.3 millimeter of mercury (mmHg) | Standard Deviation 16.37 |
| Placebo | Systolic and Diastolic Blood Pressure | Screening: SBP | 126.3 millimeter of mercury (mmHg) | Standard Deviation 15.95 |
| Placebo | Systolic and Diastolic Blood Pressure | Screening: DBP | 75.4 millimeter of mercury (mmHg) | Standard Deviation 11.46 |
| Placebo | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): SBP | 125.0 millimeter of mercury (mmHg) | Standard Deviation 13.06 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): SBP | 123.0 millimeter of mercury (mmHg) | Standard Deviation 12.39 |
| Placebo | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): DBP | 74.2 millimeter of mercury (mmHg) | Standard Deviation 9.41 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): DBP | 73.8 millimeter of mercury (mmHg) | Standard Deviation 9.07 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 2: DBP | 74.8 millimeter of mercury (mmHg) | Standard Deviation 8.85 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): SBP | 120.1 millimeter of mercury (mmHg) | Standard Deviation 12.64 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 16: DBP | 75.3 millimeter of mercury (mmHg) | Standard Deviation 10.51 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): DBP | 73.9 millimeter of mercury (mmHg) | Standard Deviation 7.71 |
| Placebo | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): SBP | 125.8 millimeter of mercury (mmHg) | Standard Deviation 16.81 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 2: SBP | 124.4 millimeter of mercury (mmHg) | Standard Deviation 14.26 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 1: DBP | 74.9 millimeter of mercury (mmHg) | Standard Deviation 11.27 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 24: DBP | 77.6 millimeter of mercury (mmHg) | Standard Deviation 9.66 |
| Placebo | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): DBP | 75.9 millimeter of mercury (mmHg) | Standard Deviation 10.13 |
| Placebo | Systolic and Diastolic Blood Pressure | Week 16: SBP | 125.4 millimeter of mercury (mmHg) | Standard Deviation 17.72 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): DBP | 69.9 millimeter of mercury (mmHg) | Standard Deviation 8.63 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): DBP | 73.5 millimeter of mercury (mmHg) | Standard Deviation 9.93 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): SBP | 111.8 millimeter of mercury (mmHg) | Standard Deviation 11.12 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): SBP | 118.0 millimeter of mercury (mmHg) | Standard Deviation 13.88 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 16: SBP | 117.4 millimeter of mercury (mmHg) | Standard Deviation 13.72 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): DBP | 73.1 millimeter of mercury (mmHg) | Standard Deviation 8.6 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): SBP | 118.5 millimeter of mercury (mmHg) | Standard Deviation 12.41 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 24: SBP | 118.3 millimeter of mercury (mmHg) | Standard Deviation 12.06 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): DBP | 74.5 millimeter of mercury (mmHg) | Standard Deviation 8.77 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 1: SBP | 117.4 millimeter of mercury (mmHg) | Standard Deviation 14.44 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Screening: DBP | 73.4 millimeter of mercury (mmHg) | Standard Deviation 9.05 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 1: DBP | 72.6 millimeter of mercury (mmHg) | Standard Deviation 9.42 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 16: DBP | 71.2 millimeter of mercury (mmHg) | Standard Deviation 8.24 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 2: SBP | 113.3 millimeter of mercury (mmHg) | Standard Deviation 11.82 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Screening: SBP | 118.5 millimeter of mercury (mmHg) | Standard Deviation 14.15 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 2: DBP | 71.3 millimeter of mercury (mmHg) | Standard Deviation 8.46 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): SBP | 115.1 millimeter of mercury (mmHg) | Standard Deviation 13.42 |
| Tanezumab 1 mg | Systolic and Diastolic Blood Pressure | Week 24: DBP | 71.9 millimeter of mercury (mmHg) | Standard Deviation 10.13 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Screening: SBP | 121.3 millimeter of mercury (mmHg) | Standard Deviation 12.25 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): SBP | 117.0 millimeter of mercury (mmHg) | Standard Deviation 14.06 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 1: DBP | 74.7 millimeter of mercury (mmHg) | Standard Deviation 9.69 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Screening: DBP | 76.4 millimeter of mercury (mmHg) | Standard Deviation 9.46 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 2: DBP | 76.8 millimeter of mercury (mmHg) | Standard Deviation 8.99 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): SBP | 119.4 millimeter of mercury (mmHg) | Standard Deviation 12.02 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 16: SBP | 119.7 millimeter of mercury (mmHg) | Standard Deviation 13.63 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 2: SBP | 118.8 millimeter of mercury (mmHg) | Standard Deviation 13.47 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 24: DBP | 78.1 millimeter of mercury (mmHg) | Standard Deviation 8.58 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): DBP | 72.0 millimeter of mercury (mmHg) | Standard Deviation 7.08 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): DBP | 73.8 millimeter of mercury (mmHg) | Standard Deviation 11.72 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 24: SBP | 122.1 millimeter of mercury (mmHg) | Standard Deviation 12.78 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): SBP | 121.5 millimeter of mercury (mmHg) | Standard Deviation 12.78 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): DBP | 75.9 millimeter of mercury (mmHg) | Standard Deviation 10.61 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): DBP | 75.2 millimeter of mercury (mmHg) | Standard Deviation 6.07 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 1: SBP | 116.8 millimeter of mercury (mmHg) | Standard Deviation 12.07 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): SBP | 119.1 millimeter of mercury (mmHg) | Standard Deviation 9.18 |
| Tanezumab 2.5 mg | Systolic and Diastolic Blood Pressure | Week 16: DBP | 72.8 millimeter of mercury (mmHg) | Standard Deviation 12.69 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 16: DBP | 75.7 millimeter of mercury (mmHg) | Standard Deviation 12.15 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Screening: SBP | 123.5 millimeter of mercury (mmHg) | Standard Deviation 12.4 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Screening: DBP | 76.8 millimeter of mercury (mmHg) | Standard Deviation 10.35 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): SBP | 121.1 millimeter of mercury (mmHg) | Standard Deviation 14.86 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): DBP | 74.5 millimeter of mercury (mmHg) | Standard Deviation 10.02 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): SBP | 123.4 millimeter of mercury (mmHg) | Standard Deviation 15.02 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): DBP | 74.8 millimeter of mercury (mmHg) | Standard Deviation 9.05 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 1: SBP | 117.9 millimeter of mercury (mmHg) | Standard Deviation 13.35 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 1: DBP | 71.6 millimeter of mercury (mmHg) | Standard Deviation 9.88 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 2: SBP | 122.0 millimeter of mercury (mmHg) | Standard Deviation 16.45 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): SBP | 122.4 millimeter of mercury (mmHg) | Standard Deviation 17.13 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): DBP | 73.4 millimeter of mercury (mmHg) | Standard Deviation 9.73 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): SBP | 120.7 millimeter of mercury (mmHg) | Standard Deviation 17.35 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): DBP | 74.8 millimeter of mercury (mmHg) | Standard Deviation 9.34 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 16: SBP | 121.8 millimeter of mercury (mmHg) | Standard Deviation 14.89 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 2: DBP | 74.5 millimeter of mercury (mmHg) | Standard Deviation 9.44 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 24: SBP | 122.4 millimeter of mercury (mmHg) | Standard Deviation 17.38 |
| Tanezumab 10 mg | Systolic and Diastolic Blood Pressure | Week 24: DBP | 73.8 millimeter of mercury (mmHg) | Standard Deviation 10.05 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 2: DBP | 72.4 millimeter of mercury (mmHg) | Standard Deviation 9.15 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Screening: DBP | 75.0 millimeter of mercury (mmHg) | Standard Deviation 9.34 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 16: SBP | 115.8 millimeter of mercury (mmHg) | Standard Deviation 10.33 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 2: SBP | 118.2 millimeter of mercury (mmHg) | Standard Deviation 12.53 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 1: DBP | 73.9 millimeter of mercury (mmHg) | Standard Deviation 10.32 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 1: SBP | 119.4 millimeter of mercury (mmHg) | Standard Deviation 12.44 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Screening: SBP | 123.2 millimeter of mercury (mmHg) | Standard Deviation 13.39 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 16: DBP | 71.2 millimeter of mercury (mmHg) | Standard Deviation 9.94 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): DBP | 76.8 millimeter of mercury (mmHg) | Standard Deviation 8.65 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Day 1(1 hour post-dose): SBP | 122.7 millimeter of mercury (mmHg) | Standard Deviation 14.17 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): DBP | 75.5 millimeter of mercury (mmHg) | Standard Deviation 9.47 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 24: DBP | 74.1 millimeter of mercury (mmHg) | Standard Deviation 7.7 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 24: SBP | 120.0 millimeter of mercury (mmHg) | Standard Deviation 12.43 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): SBP | 118.8 millimeter of mercury (mmHg) | Standard Deviation 9.98 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Day 1 (1 hour pre-dose): SBP | 121.3 millimeter of mercury (mmHg) | Standard Deviation 12.75 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour post-dose): DBP | 73.8 millimeter of mercury (mmHg) | Standard Deviation 6.15 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): DBP | 71.5 millimeter of mercury (mmHg) | Standard Deviation 7.98 |
| Tanezumab 20 mg | Systolic and Diastolic Blood Pressure | Week 8(1 hour pre-dose): SBP | 113.4 millimeter of mercury (mmHg) | Standard Deviation 11.83 |