| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent: events between first dose of study drug and up to Day 1 through Day 120 (Part 1 and 2) were absent before treatment or that worsened relative to pretreatment state | Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2. | Posted | | Count of Participants | | Participants | | Day 1 up to Day 92 for tanezumab 10, 25, 50 mcg/kg group and matching placebo group (Part 1, 2); Day 1 up to Day 120 for tanezumab 100 mcg/kg group and matching placebo group (Part 1, 2), 200 mcg/kg group and matching placebo group (Part 1) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG003 | Tanezumab 100 mcg/kg | Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG004 | Tanezumab 200 mcg/kg | Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG005 | Placebo | Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2. |
| | Units | Counts |
|---|
| Participants | - OG00015
- OG00115
- OG00215
- OG003
|
| | Title | Denominators | Categories |
|---|
| AEs | | |
| |
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Baseline | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (Part 1 and Part 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 1 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Day 1 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Day 4/5 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Day 4/5 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and 2. |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 1 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Week 1 (Part 1 and Part 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 2 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Week 2 (Part 1 and Part 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 3 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Week 3 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 4 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Week 4 (Part 1 and Part 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 13 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Week 13 (Part 1 and Part 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | |
|
| Primary | Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score at Week 17 | The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the participant's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). Higher score indicated best memory. | Safety analysis set included all participants who received single intravenous dose of study medication. Week 17 analyses was performed only for treatment arms Tanezumab 100 mcg/kg, 200 mcg/kg and Placebo as per analysis plan. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Week 17 (Part 1 and Part 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 100 mcg/kg | Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 200 mcg/kg | Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Placebo | Placebo matched to either of the single intravenous infusion over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 1 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | Full Analysis Set (FAS) included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 2 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 3 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 3 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 4 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 5 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 5 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 6 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 6 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 7 | VAS assesses participant responses from 0 to 100 (0 = none to 10 0= extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 7 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline In Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 8 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 8 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 9 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 9 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 10 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 10 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 11 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 11 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 12 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Current Index Knee Pain at Week 13 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for current index knee pain was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signify those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 13 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 1 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 2 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 3 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 3 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 4 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in The Past 24 Hours at Week 5 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 5 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 6 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 6 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 7 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 7 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 8 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 8 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 9 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 9 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 10 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 10 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 11 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 11 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 12 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain in the Past 24 Hours at Week 13 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 13 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 1 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 2 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 3 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 3 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 4 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 5 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 5 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 6 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 6 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 7 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 7 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 8 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 8 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 9 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 9 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 10 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 10 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 11 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 11 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 12 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 12 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Score For Index Knee Pain During Walking in the Past 24 Hours at Week 13 | VAS assesses participant responses from 0 to 100 (0 = none to 100 = extreme) with 101 point resolution for measuring pain intensity. Higher score indicated greater pain intensity. VAS for index knee pain during walking in the past 24 hours was recorded on the electronic diary. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 13 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
|
| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Version 3.1 (WOMAC 3.1) Subscales Scores at Week 1 | WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 1 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. |
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| Primary | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 2 | WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 |
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| Primary | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 4 | WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 4 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 |
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| Primary | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 8 | WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0=none to 100= extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 8 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 |
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| Primary | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 13 | WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living. | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 13 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 |
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| Primary | Change From Baseline in WOMAC 3.1 Subscales Scores at Week 17 | WOMAC 3.1: participant assessed questionnaire consists of 24 questions divided into 3 domains; pain (5 questions), stiffness (2 questions), function (17 questions). Functional domain provided information of ability to perform activities of daily living. The participant performed test directly on electronic diary, using validated electronic VAS ranging from 0 to 100 (0 = none to 100 = extreme). Each domain scored by averaging VAS scores of component questions. Total subscale score for each of the 3 domains range from: 0 to 100, lower score indicated better daily living. | FAS. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. Week 17: analysis was performed only for treatment arms Tanezumab 100 mcg/kg, 200 mcg/kg and Placebo as per analysis plan. It was planned to report combined data for Part 1 and 2. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 17 (Part 1 and 2) | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 100 mcg/kg | Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 200 mcg/kg | Single intravenous infusion of tanezumab 200 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Placebo |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) - Part 1 | | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. | Posted | | Geometric Mean | Standard Deviation | microgram/milliliter (mcg/mL) | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 | Tanezumab 100 mcg/kg | Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1 | | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. | Posted | | Median | Full Range | Hour | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 | Tanezumab 100 mcg/kg | Single intravenous infusion of tanezumab 100 mcg/kg over 10 minutes on Day 1 during Part 1. | |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-infinity)] - Part 1 | AUC (0-infinity) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity). | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | microgram*hour/milliliter (mcg*hr/mL) | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. |
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| Secondary | Area Under The Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Part 1 | AUClast is defined as the area under the plasma concentration time-curve from zero to the last measured concentration. | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. | Posted | | Geometric Mean | Standard Deviation | mcg*hr/mL | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 | Tanezumab 100 mcg/kg | |
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| Secondary | Volume of Distribution (Vz) - Part 1 | Vz is defined as the 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. | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | milliliter per kilogram (mL/kg) | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 |
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| Secondary | Volume of Distribution At Steady State (Vss) - Part 1 | Vss is defined as the 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. It is the apparent volume of distribution at steady-state. | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | mL/kg | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. |
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| Secondary | Systemic Clearance (CL) - Part 1 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. | Posted | | Geometric Mean | Standard Deviation | milliliter/day/kilogram (mL/day/kg) | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 | Tanezumab 100 mcg/kg |
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| Secondary | Mean Residence Time (MRT) - Part 1 | MRT was calculated as area under the moment curve/area under the concentration effect curve. | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. | Posted | | Mean | Standard Deviation | days | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 | Tanezumab 100 mcg/kg |
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| Secondary | Plasma Decay Half-Life (t1/2) - Part 1 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pharmacokinetic analysis population included all participants who received study medication, had no protocol violations and at least one plasma tanezumab concentration. Here, 'overall number of participants analyzed' signifies those who were evaluable for this measure. | Posted | | Mean | Standard Deviation | days | | Part 1: Pre-dose, Day 1 (10 minutes, 0.5, 1, 4, 12 hours post intravenous infusion), Day 2, 3, 4/5, 8, 15, 22, 29, 43, 57, 71, 92, 120 post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1. | | OG003 | Tanezumab 100 mcg/kg |
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| Secondary | Percentage of Participants With Positive Anti-tanezumab Antibody Test Results | Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). | FAS included all participants who had received full single intravenous dose of study medication and had at least one entry of electronic diary in both pre and post treatments. It was planned to report combined data for Part 1 and 2. | Posted | | Number | | percentage of participants | | Baseline up to Day 120 | | | | ID | Title | Description |
|---|
| OG000 | Tanezumab 10 mcg/kg | Single intravenous infusion of tanezumab 10 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG001 | Tanezumab 25 mcg/kg | Single intravenous infusion of tanezumab 25 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG002 | Tanezumab 50 mcg/kg | Single intravenous infusion of tanezumab 50 mcg/kg over 10 minutes on Day 1 during Part 1 and Part 2. | | OG003 | Tanezumab 100 mcg/kg |
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