| Primary | Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6 | Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score. | Intent-to-treat (ITT) population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed (n)" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| | | Title | Denominators | Categories |
|---|
| Baseline | - ParticipantsOG00031
- ParticipantsOG00133
- ParticipantsOG00232
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate. | Repeated Measures Model | P-value was based on repeated measures model from pairwise comparisons, and was 1-sided. | 0.687 | | LS Mean difference | 0.21 | Standard Error of the Mean | 0.43 | 2-Sided | 90 | -0.50 | 0.92 | | | | | Superiority | | |
|
| Secondary | Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16 | Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1, 2, 4, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | |
|
| Secondary | Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16 | Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Scores for each time interval over the weeks were calculated from the mean of daily pain score of participants over that specified duration. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 and 5 to 16) values minus the baseline value. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 |
|
| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16 | mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1 to 4 measure the magnitude of pain (Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicate less interference of pain. Pain severity score was derived from the sum of responses of questions 1-4 and ranged from 0 (no pain) to 40 (worst possible pain) with lower scores indicates less pain. Results are reported for worst pain score, average pain score and pain severity score. | ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). |
|
| Secondary | Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16 | Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of <=2 were reported. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Count of Participants | | Participants | | Week 1, 2, 4, 6, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6 | Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg |
|
| Secondary | Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6 | Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with >=30% or >=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). | Posted | | Count of Participants | | Participants | | Baseline, Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | |
|
| Secondary | Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16 | Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with >=30% or >=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at specified categories. | Posted | | Count of Participants | | Participants | | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg |
|
| Secondary | Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score | Time to achieve >=30% or >=50% sustained reduction from baseline (defined as reduction from baseline that was maintained for a total of 4 consecutive days) in average daily pain score was summarized using the Kaplan-Meier estimates. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies number of participants who had sustained response. | Posted | | Median | Full Range | days | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants | Total duration of response was defined as total number of days with a reduction of >=30% or >=50% in average daily pain score from baseline to Week 16. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Total duration with at least of >=30% or >=50% percent reduction in average daily pain NRS scores from Baseline to Week 16 were reported. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). | Posted | | Median | Full Range | days | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16 | mBPI-sf:questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1-4 assess magnitude of pain(Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists 7 item subsets which assess level of interference of pain on daily functions: 1: general activity (GA),2: mood, 3: walking ability, 4: normal work (NW),5: relations with other,6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. These 7 items were averaged to obtain pain interference composite score (CS), ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. Change from baseline in mBPI-sf score for pain interference with CS score, GA subtest and NW subtest were reported. | ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1, 2, 4, 6, 8, 12 and 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). |
|
| Secondary | Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16 | Patient's global assessment of pain from post-herpetic neuralgia assessed participant's overall impression of disease activity. Participants answered: "Considering all the ways your pain from post-herpetic neuralgia, how are you doing today?". Participants responded using a 5--point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor) with lower scores indicating better condition. Number of participants who reported a change from Baseline of -4, -3, -2, -1, 0, 1, 2, 3, 4 in Patient's Global Assessment of Pain scores at each specified time-point were presented. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Count of Participants | | Participants | | Baseline, Week 1, 2, 4, 6, 8 ,12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | |
|
| Secondary | Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication | Participants provided their response for patient's global evaluation of study medication by answering a question. Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-¬point likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicating better overall response to the treatment. Number of participants with each response level (poor, fair, good and excellent) were reported. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Count of Participants | | Participants | | Week 1, 2, 4, 6, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | |
|
| Secondary | Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16 | mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions (Q) 1-4 assess magnitude of pain severity (Q1 for worst, Q2 for least, Q3 for average, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which assess the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item was assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicated less interference of pain. Change from Baseline in mBPI-sf score for pain interference with sleep were reported. | ITT population included all randomized participants who received Day 1 IV infusion (either tanezumab or placebo). Here, ''overall number of participants analyzed'' signifies number of participants evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1, 2, 4, 6, 8, 12, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 |
|
| Secondary | Number of Participants Who Discontinued the Study Due to Lack of Efficacy | | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Time to Discontinuation Due to Lack of Efficacy | Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). | Posted | | Mean | Standard Error | days | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Number of Participants Who Used Rescue Medications | In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of participants with any use of rescue medication during the specified study week were summarized. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Count of Participants | | Participants | | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Duration of Rescue Medication Use | In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participant used rescue medication, during the specified weeks were summarized. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Median | Full Range | days | | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Amount of Rescue Medication Taken | In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen (in mg) used during the specified week were summarized. | ITT population included all randomized participants who received the Day 1 IV infusion (either tanezumab or placebo). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | milligram | | Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of 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 (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). | Posted | | Count of Participants | | Participants | | Baseline up to 112 days after the last dose of study drug (up to Week 16) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | |
|
| Secondary | Number of Participants With Abnormal Physical Examinations Findings at Screening | Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. Abnormalities in physical examination was based on investigator's discretion. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, "number analyzed" signifies those participants who were evaluable for specified categories. | Posted | | Count of Participants | | Participants | | Screening visit (1 day prior to Day 1 baseline visit) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16 | Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16 | Neurological examination included the assessment of cranial nerve function, coordination, reflexes, proprioception, mental status, motor function, gait and station and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation). | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16 | Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Criteria for clinically significant vital signs included: heart rate value of less than (<) 40 beats per minute and greater than (>) 150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). | Posted | | Count of Participants | | Participants | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Number of Participants With Laboratory Abnormalities | Abnormality criteria: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma GT, LDH, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium <0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).](streamdown:incomplete-link) | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | |
|
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for abnormality in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG002 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
|
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) Response | Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for PF-04383119 were considered as ADA positive. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Data for this outcome measure was not planned to be assessed collected and reported only for Tanezumab 50, 200 mcg/kg reporting group, not for placebo group. | Posted | | Count of Participants | | Participants | | Baseline up to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Secondary | Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study | HVLT-R was a word-list learning and memory test used to assess the changes in memory. The task was repeated, for a total of 3 learning trials. After a delay interval of 20 to 25 minutes, delayed recall trial was administered. 1)Learning efficiency: Assessed by examining the learning curve over 3 learning trials and by evaluating the sum of the scores for all 3 learning trials. Raw scores for each of the 3 learning trials were summed for the total recall (TR) score. The TR score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall, 2) Ability to access newly learned information: Assessed by the number of words retained on the delayed recall (DR) trial and the percentage of words recalled from the word list. DR trial score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall. | Safety analysis population included all participants who received the day 1 IV infusion (either tanezumab or placebo infusion). Here, "number analyzed" signifies those participants who were evaluable at given time points. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received single intravenous (IV) infusion of placebo matched to tanezumab (RN624 or PF-04383119) at Baseline (Day 1). | | OG001 | Tanezumab 50 mcg/kg | |
|
| Secondary | Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | Pharmacokinetic (PK) analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group. | Posted | | Mean | Standard Deviation | nanogram*hour per milliliter (ng*hr/mL) | | Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Other Pre-specified | Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab | Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). | PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Other Pre-specified | Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose | Plasma concentration of tanezumab at nominal collection time of 1 hour post-dose (C1) and plasma concentration at nominal collection time of 2688 hours post-dose (C2688) were reported. | PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group. | Posted | | Mean | Standard Deviation | nanogram per milliliter | | 1, 2688 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Other Pre-specified | Total Clearance of Tanezumab From Plasma | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). | PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group. | Posted | | Mean | Standard Deviation | milliliter per hour per kilogram | | Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Other Pre-specified | Terminal Elimination Half-Life (t1/2) of Tanezumab | Terminal elimination half-life is the time measured for the plasma concentration of tanezumab to decrease by one half of its original concentration. | PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for placebo group. | Posted | | Mean | Standard Deviation | days | | Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |
| Other Pre-specified | Volume of Distribution at Steady State (Vss) for Tanezumab | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. | PK analysis population included all participants who had at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed placebo group. | Posted | | Mean | Standard Deviation | milliliter per kilogram | | Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 50 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 50 microgram per kilogram (mcg/kg) at Baseline (Day 1). | | OG001 | Tanezumab 200 mcg/kg | Participants received single IV infusion of Tanezumab (RN624 or PF 04383119) 200 mcg/kg at Baseline (Day 1). |
| |