Trial · NCT02510261
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events (AEs) Leading to Study Discontinuation | First dose up to 28 days after last dose of study drug (approximately 5.6 years) | Safety analysis set included all the enrolled participants who received at least 1 dose of patisiran in this study. Percentages are rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Total Neuropathy Impairment Score (NIS) at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Total Modified NIS (mNIS +7) Composite Score At Year 3 | Baseline, Year 3 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the NIS+7 Total Score at Week 52 | Baseline, Week 52 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Total Score at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the EuroQOL-5 Dimensions-5 Levels (EQ-5D-5L) Index Score at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Composite Autonomic Symptom Score (COMPASS 31) Total Score at Week 52 | Baseline, Week 52 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Modified Body Mass Index (mBMI) at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | kg.g/m^2.L | MEAN |
| SECONDARY | Change From Baseline in the Rasch-built Overall Disability Scale (R-ODS) at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the NIS+7 Component: NIS-Weakness (NIS-W) Score at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the 10-meter Walk Test (10-MWT) Speed at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | m/s | MEAN |
| SECONDARY | Change From Baseline in the Hand Grip Strength at Week 52 | Baseline, Week 52 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | kg | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in the Polyneuropathy Disability (PND) Stage | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in the Familial Amyloidotic Polyneuropathy (FAP) Stage | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Change From Baseline in the New York Heart Association (NYHA) Classification | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Intraepidermal Nerve Fiber Density (IENFD) at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of the specified parameter at specified timepoint. | fibers/mm | MEAN |
| SECONDARY | Change From Baseline in the Sweat Gland Nerve Fiber Density (SGNFD) at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number of participants analyzed' indicates the number of participants with data available for analysis of the specified parameter at specified timepoint. | m/mm^3 | MEAN |
| SECONDARY | Change From Baseline in the Dermal Amyloid Burden at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of the specified parameter at specified timepoint. | percent congo red stain | MEAN |
| SECONDARY | Change From Baseline in the Cardiac Biomarker: Serum Troponin I at Year 5 | Baseline, Year 5 | Full analysis set included all participants who were enrolled in this study. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint. | µg/L | 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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