Trial · NCT04828993
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Neuropathy Impairment Score-lower Limb (NIS-LL) Total Score at Week 72 | Baseline, Week 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Neuropathy Impairment Score-lower Limb (NIS-LL) Total Score at Weeks 24, and 48 | Baseline, Week 24, Week 48 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Total Quality of Life (TQOL) of Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN) at Weeks 24, 48, and 72 | Baseline, Week 24, Week 48, Week 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in 5 Domains of Norfolk QOL-DN at Weeks 24, 48, and 72 | Baseline, Week 24, Week 48, Week 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Modified Body Mass Index (mBMI) at Weeks 4, 8, 12, 24, 36, 48, and 72 | Baseline, Weeks 4, 8, 12, 24, 36, 48, and 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | kg/m^2*g/L | MEDIAN |
| SECONDARY | Change From Baseline in Physical Component Summary and Mental Component Summary of 36-Item Short Form Survey (SF-36) at Weeks 24, 48, and 72 | Baseline, Weeks 24, 48, and 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Index Score at Weeks 24, 48, and 72 | Baseline, Weeks 24, 48, and 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Units on a scale | MEDIAN |
| SECONDARY | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Week 77 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Categorical Vital Signs Data | Baseline up to Week 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Categorical Electrocardiogram (ECG) Data | Baseline up to Week 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Echocardiography (ECHO) Value Related to Primary Diagnosis (Transthyretin Amyloidosis [ATTR]) at Baseline, Weeks 24, 48, and 72 | Baseline, Weeks 24, 48, and 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Laboratory Abnormalities | Baseline up to Week 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transthyretin (TTR) Concentrations on Day 1 (Baseline), and at Weeks 8, 12, 24, 48, and 72 | Baseline, Weeks 8, 12, 24, 48, and 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg and who had at least 1 TTR concentration value. | Milligrams per deciliter (mg/dL) | MEDIAN |
| SECONDARY | TTR Stabilization and Percentage and 95% CI of Responders in TTR Stabilization at Post Baseline Visit | Weeks 8, 12, 24, 48, and 72 | All participants who took at least 1 dose of tafamidis meglumine soft gelatin capsule 20 mg and who had at least 1 TTR stabilization value. | Percentage of participants | NUMBER |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04828993/outcomes