Trial · NCT00924664
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 112 days after last dose of study treatment (up to 448 days) | Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | A4091012: Baseline, A4091039: Week 4 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | A4091012: Baseline, A4091039: Week 8 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 | A4091012: Baseline, A4091039: Week 16 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 | A4091012: Baseline, A4091039: Week 24 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 | A4091012: Baseline, A4091039: Week 32 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 | A4091012: Baseline, A4091039: Week 40 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 | A4091012: Baseline, A4091039: Week 48 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56 | A4091012: Baseline, A4091039: Week 56 | ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 56 since none of the participants received dosing beyond Week 32 and safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | A4091012: Baseline, A4091039: Week 4 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 8 | A4091012: Baseline, A4091039: Week 8 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 16 | A4091012: Baseline, A4091039: Week 16 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 24 | A4091012: Baseline, A4091039: Week 24 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 32 | A4091012: Baseline, A4091039: Week 32 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 40 | A4091012: Baseline, A4091039: Week 40 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 48 | A4091012: Baseline, A4091039: Week 48 | ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 48 since none of the participants received dosing beyond Week 32 and efficacy assessment was not required after clinical hold. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 56 | A4091012: Baseline, A4091039: Week 56 | Data was not collected at Week 56 since efficacy assessment was not required after clinical hold. | ||
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 4 | A4091012: Baseline, A4091039: Week 4 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 8 | A4091012: Baseline, A4091039: Week 8 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Scores (General Activity, Walking Ability, Normal Work, Sleep, Function Composite) at Week 16 | A4091012: Baseline, A4091039: Week 16 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively. | units on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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