Please select the outcome measures that correspond to the clinical trial below.
Title: OPEN-LABEL SAFETY AND EFFICACY EVALUATION OF FX-1006A IN SUBJECTS WITH TRANSTHYRETIN (TTR) AMYLOIDOSIS
Brief Summary: This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD). In addition, this study continued to provide tafamidis to Val30Met subjects who had completed Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon regulatory approval for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were considered study completers.


Options:
A: Modified Neuropathy Impairment Score +7 (mNIS+7) (18mo)
B: Change From Baseline In The Modified Neuropathy Impairment Score (mNIS) +7 Composite Score at Week 66 (Baseline and Week 66); Change From Baseline In The Norfolk Quality Of Life Diabetic Neuropathy (QoL-DN) Questionnaire at Week 66 (Baseline and Week 66)
C: Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline (Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005)); Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30 (Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 30); Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66 (Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 66); NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline (Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201)); NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12 (Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 12); NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60 (Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 60); Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline (Baseline of B3461020 (Fx-005)); Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 30 (Baseline of B3461020 (Fx-005), Month 30); Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 66 (Baseline of B3461020 (Fx-005), Month 66); NonVal30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline (Baseline of B3461022 (Fx1A-201)); NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 12 (Baseline of B3461022 (Fx1A-201), Month 12); NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 60 (Baseline of B3461022 (Fx1A-201), Month 60); Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 30 (Month 30 (Baseline of B3461023)); Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 66 (Month 66 (Month 36 of B3461023)); NonVal30Met Group: Karnofsky Performance Scale (KPS) Score at Baseline (Baseline of B3461022 (Fx1A-201)); NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 12 (Baseline of B3461022 (Fx1A-201), Month 12); NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 60 (Baseline of B3461022 (Fx1A-201), Month 60); Val30Met Group: Number of Participants by Ambulation Stage at Baseline (Baseline of B3461020 (Fx-005)); Val30Met Group: Number of Participants by Ambulation Stage at Month 30 (Month 30); Val30Met Group: Number of Participants by Ambulation Stage at Month 66 (Month 66); NonVal30Met Group: Number of Participants by Ambulation Stage at Baseline (Baseline of B3461022 (Fx1A-201)); NonVal30Met Group: Number of Participants by Ambulation Stage at Month 12 (Month 12); NonVal30Met Group: Number of Participants by Ambulation Stage at Month 60 (Month 60)
D: Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 6 (Month 6); Percentage of Participants With Response to Treatment as Measured by Neuropathy Impairment Score - Lower Limb (NIS-LL) at Month 12 (Month 12); Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 6 (Baseline, Month 6); Change From Baseline in Norfolk Quality of Life- Diabetic Neuropathy (QOL-DN) Total Quality of Life (TQOL) Score at Month 12 (Baseline, Month 12)

Answer: C