Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients With TTR Amyloidosis
Brief Summary: This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).


Options:
A: 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)
B: Percentage of Participants With Stabilized Transthyretin (TTR) Tetramer at Week 6 (Week 6)
C: Modified Neuropathy Impairment Score +7 (mNIS+7) (18mo)
D: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation (Up to 56 days post first dose)

Answer: D