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Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935012
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions ATTR-CM
TTR-CM
Intervention Drug: tafamidis
Enrollment 31
Recruitment Details Participants with transthyretin amyloid cardiomyopathy (TTR-CM/ATTR-CM), who had not undergone liver or heart transplantation and who had completed previous study Fx1B-201 (NCT00694161) were eligible to enter this current study Fx1B-303 (NCT00935012).
Pre-assignment Details In this study, participants continued on same dose they had received in initial study. Data for time points from Baseline to Month 12 are from study Fx1B-201, while data for time points after Month 12 are from study Fx1B-303.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Period Title: Overall Study
Started 31
Completed 2
Not Completed 29
Reason Not Completed
Death             19
Withdrawal by Subject             3
Other             5
Adverse Event             2
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
The intent to treat (ITT) population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
77.6  (4.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
3
   9.7%
Male
28
  90.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Caucasian
27
  87.1%
Afro-caribbean
1
   3.2%
African American
3
   9.7%
1.Primary Outcome
Title Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12
Hide Description Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, "How do you feel today as compared to when we talked with you at your last clinic visit for this study?" and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Markedly Improved
0
(0.0 to 11.2)
Moderately Improved
16.1
(5.5 to 33.7)
Mildly Improved
9.7
(2.0 to 25.8)
Unchanged
51.6
(33.1 to 69.8)
Mildly Worsened
12.9
(3.6 to 29.8)
Moderately Worsened
9.7
(2.0 to 25.8)
Markedly Worsened
0
(0.0 to 11.2)
2.Primary Outcome
Title Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60
Hide Description Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, "How do you feel today as compared to when we talked with you at your last clinic visit for this study?" and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Markedly Improved
0
(0.0 to 26.5)
Moderately Improved
8.3
(0.2 to 38.5)
Mildly Improved
8.3
(0.2 to 38.5)
Unchanged
50.0
(21.1 to 78.9)
Mildly Worsened
16.7
(2.1 to 48.4)
Moderately Worsened
16.7
(2.1 to 48.4)
Markedly Worsened
0
(0.0 to 26.5)
3.Primary Outcome
Title Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline
Hide Description NYHA classified participants in 4 classes. Class I included participants with cardiac disease without limitations of physical activity. Ordinary physical activity did not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II included participants with cardiac disease with slight limitation of physical activity. They were comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea, or anginal pain. Class III included participants with cardiac disease with marked limitation of physical activity. They were comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea, or anginal pain. Class IV included participants with cardiac disease with the inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
CLASS I
4
  12.9%
CLASS II
26
  83.9%
CLASS III
1
   3.2%
CLASS IV
0
   0.0%
4.Primary Outcome
Title Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12
Hide Description NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Worsened
7
  22.6%
Unchanged
20
  64.5%
Improved
4
  12.9%
5.Primary Outcome
Title Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60
Hide Description NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
Worsened
8
  66.7%
Unchanged
3
  25.0%
Improved
1
   8.3%
6.Primary Outcome
Title Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: meters
Baseline Number Analyzed 30 participants
363.7  (130.80)
Change at Month 12 Number Analyzed 28 participants
-11.2  (76.39)
7.Primary Outcome
Title Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated.
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: meters
-121.4  (145.82)
8.Primary Outcome
Title Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked less than (<) 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked greater than or equal to (>=) 450 meter.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
Level 1
8
  28.6%
Level 2
7
  25.0%
Level 3
7
  25.0%
Level 4
6
  21.4%
9.Primary Outcome
Title Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked < 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked >=450 meter.
Time Frame Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Level 1
4
  50.0%
Level 2
3
  37.5%
Level 3
0
   0.0%
Level 4
1
  12.5%
10.Primary Outcome
Title Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at Month 12.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure. "Number analyzed"=participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Dyspnea: Baseline, Pre walk Number Analyzed 28 participants
0.6  (0.72)
Dyspnea: Baseline, Post walk Number Analyzed 28 participants
2.5  (1.94)
Dyspnea: Baseline, Within Visit Difference Number Analyzed 28 participants
1.9  (1.94)
Dyspnea: Change at Month 12, Pre walk Number Analyzed 26 participants
0.6  (1.61)
Dyspnea: Change at Month 12, Post walk Number Analyzed 26 participants
1.2  (1.60)
Dyspnea:Change at Month 12,Within Visit Difference Number Analyzed 26 participants
0.6  (1.70)
Fatigue: Baseline, Pre-walk Number Analyzed 28 participants
0.9  (1.27)
Fatigue: Baseline, Post-walk Number Analyzed 28 participants
2.4  (2.06)
Fatigue: Baseline, Within Visit Difference Number Analyzed 28 participants
1.4  (2.51)
Fatigue: Change at Month 12, Pre Walk Number Analyzed 26 participants
0.5  (2.20)
Fatigue: Change at Month 12, Post-Walk Number Analyzed 26 participants
0.9  (1.98)
Fatigue:Change at Month 12,Within Visit Difference Number Analyzed 26 participants
0.4  (2.20)
11.Primary Outcome
Title Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at Month 60.
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Dyspnea: Change at Month 60, Pre walk 0.8  (1.41)
Dyspnea: Change at Month 60, Post walk 0.8  (1.60)
Dyspnea:Change at Month 60,Within Visit Difference 0.1  (1.94)
Fatigue: Change at Month 60, Pre walk 0.1  (0.35)
Fatigue: Change at Month 60, Post walk 0.4  (1.51)
Fatigue:Change at Month 60,Within Visit Difference 0.3  (1.49)
12.Primary Outcome
Title Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
Worsened
7
  25.0%
Unchanged
16
  57.1%
Improved
5
  17.9%
13.Primary Outcome
Title Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'.
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Worsened
5
  62.5%
Unchanged
3
  37.5%
Improved
0
   0.0%
14.Primary Outcome
Title Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12
Hide Description KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Summary Score: Baseline Number Analyzed 31 participants
72.21  (18.974)
Overall Summary Score: Change at Month 12 Number Analyzed 30 participants
-4.54  (12.724)
Clinical Summary Score: Baseline Number Analyzed 31 participants
74.79  (19.296)
Clinical Summary Score: Change at Month 12 Number Analyzed 30 participants
-5.60  (13.792)
15.Primary Outcome
Title Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60
Hide Description KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status.
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Summary Score: Change at Month 60 -12.93  (29.306)
Clinical Summary Score: Change at Month 60 -18.12  (29.432)
16.Primary Outcome
Title Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12
Hide Description Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage.
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Troponin I: Baseline 0.132  (0.0627)
Troponin I: Change at Month 12 0.016  (0.0652)
Troponin T: Baseline 0.0448  (0.03402)
Troponin T: Change at Month 12 0.0110  (0.02239)
17.Primary Outcome
Title Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60
Hide Description Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage.
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Troponin T: Change at Month 60 Number Analyzed 11 participants
0.026  (0.0937)
Troponin I: Change at Month 60 Number Analyzed 10 participants
0.0810  (0.17779)
18.Primary Outcome
Title Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12
Hide Description NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular [LV] wall stress).
Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Baseline Number Analyzed 31 participants
4526.1  (3814.21)
Change at Month 12 Number Analyzed 30 participants
818.3  (3133.86)
19.Primary Outcome
Title Change From Baseline in Serum Levels of Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) at Month 60
Hide Description NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).
Time Frame Baseline, Month 60
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population consisted of all participants who were enrolled in this study and who had taken at least one dose of study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
5127.6  (10598.94)
20.Secondary Outcome
Title Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
Hide Description Participants overall quality of life was measured by PGA. At each follow-up visit, participants were asked, "How do you feel today as compared to when we talked with you at your last clinic visit for this study?" and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Time Frame Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 6: Markedly Improved Number Analyzed 31 participants
9.7
(2.0 to 25.8)
Month 6: Moderately Improved Number Analyzed 31 participants
3.2
(0.1 to 16.7)
Month 6: Mildly Improved Number Analyzed 31 participants
9.7
(2.0 to 25.8)
Month 6: Unchanged Number Analyzed 31 participants
51.6
(33.1 to 69.8)
Month 6: Mildly Worsened Number Analyzed 31 participants
25.8
(11.9 to 44.6)
Month 6: Moderately Worsened Number Analyzed 31 participants
0
(0.0 to 11.2)
Month 6: Markedly Worsened Number Analyzed 31 participants
0
(0.0 to 11.2)
Month 18: Markedly Improved Number Analyzed 28 participants
7.1
(0.9 to 23.5)
Month 18: Moderately Improved Number Analyzed 28 participants
10.7
(2.3 to 28.2)
Month 18: Mildly Improved Number Analyzed 28 participants
17.9
(6.1 to 36.9)
Month 18: Unchanged Number Analyzed 28 participants
25.0
(10.7 to 44.9)
Month 18: Mildly Worsened Number Analyzed 28 participants
17.9
(6.1 to 36.9)
Month 18: Moderately Worsened Number Analyzed 28 participants
10.7
(2.3 to 28.2)
Month 18: Markedly Worsened Number Analyzed 28 participants
10.7
(2.3 to 28.2)
Month 24: Markedly Improved Number Analyzed 22 participants
9.1
(1.1 to 29.2)
Month 24: Moderately Improved Number Analyzed 22 participants
18.2
(5.2 to 40.3)
Month 24: Mildly Improved Number Analyzed 22 participants
13.6
(2.9 to 34.9)
Month 24: Unchanged Number Analyzed 22 participants
27.3
(10.7 to 50.2)
Month 24: Mildly Worsened Number Analyzed 22 participants
22.7
(7.8 to 45.4)
Month 24: Moderately Worsened Number Analyzed 22 participants
4.5
(0.1 to 22.8)
Month 24: Markedly Worsened Number Analyzed 22 participants
4.5
(0.1 to 22.8)
Month 30: Markedly Improved Number Analyzed 20 participants
0
(0.0 to 16.8)
Month 30: Moderately Improved Number Analyzed 20 participants
10.0
(1.2 to 31.7)
Month 30: Mildly Improved Number Analyzed 20 participants
5.0
(0.1 to 24.9)
Month 30: Unchanged Number Analyzed 20 participants
40.0
(19.1 to 63.9)
Month 30: Mildly Worsened Number Analyzed 20 participants
25.0
(8.7 to 49.1)
Month 30: Moderately Worsened Number Analyzed 20 participants
20.0
(5.7 to 43.7)
Month 30: Markedly Worsened Number Analyzed 20 participants
0
(0.0 to 16.8)
Month 36: Markedly Improved Number Analyzed 19 participants
0
(0.0 to 17.6)
Month 36: Moderately Improved Number Analyzed 19 participants
0
(0.0 to 17.6)
Month 36: Mildly Improved Number Analyzed 19 participants
5.3
(0.1 to 26.0)
Month 36: Unchanged Number Analyzed 19 participants
47.4
(24.4 to 71.1)
Month 36: Mildly Worsened Number Analyzed 19 participants
26.3
(9.1 to 51.2)
Month 36: Moderately Worsened Number Analyzed 19 participants
21.1
(6.1 to 45.6)
Month 36: Markedly Worsened Number Analyzed 19 participants
0
(0.0 to 17.6)
Month 42: Markedly Improved Number Analyzed 17 participants
0
(0.0 to 19.5)
Month 42: Moderately Improved Number Analyzed 17 participants
0
(0.0 to 19.5)
Month 42: Mildly Improved Number Analyzed 17 participants
0
(0.0 to 19.5)
Month 42: Unchanged Number Analyzed 17 participants
29.4
(10.3 to 56.0)
Month 42: Mildly Worsened Number Analyzed 17 participants
35.3
(14.2 to 61.7)
Month 42: Moderately Worsened Number Analyzed 17 participants
11.8
(1.5 to 36.4)
Month 42: Markedly Worsened Number Analyzed 17 participants
23.5
(6.8 to 49.9)
Month 48: Markedly Improved Number Analyzed 13 participants
0
(0.0 to 24.7)
Month 48: Moderately Improved Number Analyzed 13 participants
0
(0.0 to 24.7)
Month 48: Mildly Improved Number Analyzed 13 participants
23.1
(5.0 to 53.8)
Month 48: Unchanged Number Analyzed 13 participants
53.8
(25.1 to 80.8)
Month 48: Mildly Worsened Number Analyzed 13 participants
15.4
(1.9 to 45.4)
Month 48: Moderately Worsened Number Analyzed 13 participants
7.7
(0.2 to 36.0)
Month 48: Markedly Worsened Number Analyzed 13 participants
0
(0.0 to 24.7)
Month 54: Markedly Improved Number Analyzed 13 participants
0
(0.0 to 24.7)
Month 54: Moderately Improved Number Analyzed 13 participants
7.7
(0.2 to 36.0)
Month 54: Mildly Improved Number Analyzed 13 participants
0
(0.0 to 24.7)
Month 54: Unchanged Number Analyzed 13 participants
61.5
(31.6 to 86.1)
Month 54: Mildly Worsened Number Analyzed 13 participants
23.1
(5.0 to 53.8)
Month 54: Moderately Worsened Number Analyzed 13 participants
7.7
(0.2 to 36.0)
Month 54: Markedly Worsened Number Analyzed 13 participants
0
(0.0 to 24.7)
Month 66: Markedly Improved Number Analyzed 6 participants
16.7
(0.4 to 64.1)
Month 66: Moderately Improved Number Analyzed 6 participants
0
(0.0 to 45.9)
Month 66: Mildly Improved Number Analyzed 6 participants
0
(0.0 to 45.9)
Month 66: Unchanged Number Analyzed 6 participants
50.0
(11.8 to 88.2)
Month 66: Mildly Worsened Number Analyzed 6 participants
0
(0.0 to 45.9)
Month 66: Moderately Worsened Number Analyzed 6 participants
33.3
(4.3 to 77.7)
Month 66: Markedly Worsened Number Analyzed 6 participants
0
(0.0 to 45.9)
Month 72: Markedly Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 72: Moderately Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 72: Mildly Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 72: Unchanged Number Analyzed 7 participants
71.4
(29.0 to 96.3)
Month 72: Mildly Worsened Number Analyzed 7 participants
28.6
(3.7 to 71.0)
Month 72: Moderately Worsened Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 72: Markedly Worsened Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 78: Markedly Improved Number Analyzed 7 participants
14.3
(0.4 to 57.9)
Month 78: Moderately Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 78: Mildly Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 78: Unchanged Number Analyzed 7 participants
28.6
(3.7 to 71.0)
Month 78: Mildly Worsened Number Analyzed 7 participants
28.6
(3.7 to 71.0)
Month 78: Moderately Worsened Number Analyzed 7 participants
28.6
(3.7 to 71.0)
Month 78: Markedly Worsened Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 84: Markedly Improved Number Analyzed 6 participants
16.7
(0.4 to 64.1)
Month 84: Moderately Improved Number Analyzed 6 participants
0
(0.0 to 45.9)
Month 84: Mildly Improved Number Analyzed 6 participants
0
(0.0 to 45.9)
Month 84: Unchanged Number Analyzed 6 participants
33.3
(4.3 to 77.7)
Month 84: Mildly Worsened Number Analyzed 6 participants
16.7
(0.4 to 64.1)
Month 84: Moderately Worsened Number Analyzed 6 participants
16.7
(0.4 to 64.1)
Month 84: Markedly Worsened Number Analyzed 6 participants
16.7
(0.4 to 64.1)
Month 90: Markedly Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 90: Moderately Improved Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 90: Mildly Improved Number Analyzed 7 participants
42.9
(9.9 to 81.6)
Month 90: Unchanged Number Analyzed 7 participants
28.6
(3.7 to 71.0)
Month 90: Mildly Worsened Number Analyzed 7 participants
28.6
(3.7 to 71.0)
Month 90: Moderately Worsened Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 90: Markedly Worsened Number Analyzed 7 participants
0
(0.0 to 41.0)
Month 96: Markedly Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 96: Moderately Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 96: Mildly Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 96: Unchanged Number Analyzed 4 participants
25.0
(0.6 to 80.6)
Month 96: Mildly Worsened Number Analyzed 4 participants
50.0
(6.8 to 93.2)
Month 96: Moderately Worsened Number Analyzed 4 participants
25.0
(0.6 to 80.6)
Month 96: Markedly Worsened Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 102: Markedly Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 102: Moderately Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 102: Mildly Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 102: Unchanged Number Analyzed 4 participants
75.0
(19.4 to 99.4)
Month 102: Mildly Worsened Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 102: Moderately Worsened Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 102: Markedly Worsened Number Analyzed 4 participants
25.0
(0.6 to 80.6)
Month 108: Markedly Improved Number Analyzed 5 participants
40.0
(5.3 to 85.3)
Month 108: Moderately Improved Number Analyzed 5 participants
0
(0.0 to 52.2)
Month 108: Mildly Improved Number Analyzed 5 participants
20.0
(0.5 to 71.6)
Month 108: Unchanged Number Analyzed 5 participants
40.0
(5.3 to 85.3)
Month 108: Mildly Worsened Number Analyzed 5 participants
0
(0.0 to 52.2)
Month 108: Moderately Worsened Number Analyzed 5 participants
0
(0.0 to 52.2)
Month 108: Markedly Worsened Number Analyzed 5 participants
0
(0.0 to 52.2)
Month 114: Markedly Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 114: Moderately Improved Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 114: Mildly Improved Number Analyzed 4 participants
25.0
(0.6 to 80.6)
Month 114: Unchanged Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 114: Mildly Worsened Number Analyzed 4 participants
75.0
(19.4 to 99.4)
Month 114: Moderately Worsened Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 114: Markedly Worsened Number Analyzed 4 participants
0
(0.0 to 60.2)
Month 120: Markedly Improved Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 120: Moderately Improved Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 120: Mildly Improved Number Analyzed 2 participants
50.0
(1.3 to 98.7)
Month 120: Unchanged Number Analyzed 2 participants
50.0
(1.3 to 98.7)
Month 120: Mildly Worsened Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 120: Moderately Worsened Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 120: Markedly Worsened Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 126: Markedly Improved Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 126: Moderately Improved Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 126: Mildly Improved Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 126: Unchanged Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 126: Mildly Worsened Number Analyzed 2 participants
100.0
(15.8 to 100.0)
Month 126: Moderately Worsened Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 126: Markedly Worsened Number Analyzed 2 participants
0
(0.0 to 84.2)
Month 132: Markedly Improved Number Analyzed 1 participants
0
(0.0 to 97.5)
Month 132: Moderately Improved Number Analyzed 1 participants
0
(0.0 to 97.5)
Month 132: Mildly Improved Number Analyzed 1 participants
0
(0.0 to 97.5)
Month 132: Unchanged Number Analyzed 1 participants
0
(0.0 to 97.5)
Month 132: Mildly Worsened Number Analyzed 1 participants
100.0
(2.5 to 100.0)
Month 132: Moderately Worsened Number Analyzed 1 participants
0
(0.0 to 97.5)
Month 132: Markedly Worsened Number Analyzed 1 participants
0
(0.0 to 97.5)
21.Secondary Outcome
Title Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
Hide Description NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6: Worsened Number Analyzed 31 participants
5
  16.1%
Month 6: Unchanged Number Analyzed 31 participants
25
  80.6%
Month 6: Improved Number Analyzed 31 participants
1
   3.2%
Month 18: Worsened Number Analyzed 27 participants
7
  25.9%
Month 18: Unchanged Number Analyzed 27 participants
17
  63.0%
Month 18: Improved Number Analyzed 27 participants
3
  11.1%
Month 24: Worsened Number Analyzed 22 participants
7
  31.8%
Month 24: Unchanged Number Analyzed 22 participants
12
  54.5%
Month 24: Improved Number Analyzed 22 participants
3
  13.6%
Month 30: Worsened Number Analyzed 20 participants
4
  20.0%
Month 30: Unchanged Number Analyzed 20 participants
14
  70.0%
Month 30: Improved Number Analyzed 20 participants
2
  10.0%
Month 36: Worsened Number Analyzed 19 participants
6
  31.6%
Month 36: Unchanged Number Analyzed 19 participants
11
  57.9%
Month 36: Improved Number Analyzed 19 participants
2
  10.5%
Month 42: Worsened Number Analyzed 17 participants
10
  58.8%
Month 42: Unchanged Number Analyzed 17 participants
5
  29.4%
Month 42: Improved Number Analyzed 17 participants
2
  11.8%
Month 48: Worsened Number Analyzed 12 participants
6
  50.0%
Month 48: Unchanged Number Analyzed 12 participants
4
  33.3%
Month 48: Improved Number Analyzed 12 participants
2
  16.7%
Month 54: Worsened Number Analyzed 12 participants
6
  50.0%
Month 54: Unchanged Number Analyzed 12 participants
6
  50.0%
Month 54: Improved Number Analyzed 12 participants
0
   0.0%
Month 66: Worsened Number Analyzed 6 participants
5
  83.3%
Month 66: Unchanged Number Analyzed 6 participants
1
  16.7%
Month 66: Improved Number Analyzed 6 participants
0
   0.0%
Month 72: Worsened Number Analyzed 7 participants
2
  28.6%
Month 72: Unchanged Number Analyzed 7 participants
5
  71.4%
Month 72: Improved Number Analyzed 7 participants
0
   0.0%
Month 78: Worsened Number Analyzed 7 participants
3
  42.9%
Month 78: Unchanged Number Analyzed 7 participants
4
  57.1%
Month 78: Improved Number Analyzed 7 participants
0
   0.0%
Month 84: Worsened Number Analyzed 6 participants
3
  50.0%
Month 84: Unchanged Number Analyzed 6 participants
3
  50.0%
Month 84: Improved Number Analyzed 6 participants
0
   0.0%
Month 90: Worsened Number Analyzed 7 participants
3
  42.9%
Month 90: Unchanged Number Analyzed 7 participants
4
  57.1%
Month 90: Improved Number Analyzed 7 participants
0
   0.0%
Month 96: Worsened Number Analyzed 5 participants
3
  60.0%
Month 96: Unchanged Number Analyzed 5 participants
1
  20.0%
Month 96: Improved Number Analyzed 5 participants
1
  20.0%
Month 102: Worsened Number Analyzed 5 participants
2
  40.0%
Month 102: Unchanged Number Analyzed 5 participants
2
  40.0%
Month 102: Improved Number Analyzed 5 participants
1
  20.0%
Month 108: Worsened Number Analyzed 5 participants
2
  40.0%
Month 108: Unchanged Number Analyzed 5 participants
1
  20.0%
Month 108: Improved Number Analyzed 5 participants
2
  40.0%
Month 114: Worsened Number Analyzed 4 participants
2
  50.0%
Month 114: Unchanged Number Analyzed 4 participants
2
  50.0%
Month 114: Improved Number Analyzed 4 participants
0
   0.0%
Month 120: Worsened Number Analyzed 4 participants
3
  75.0%
Month 120: Unchanged Number Analyzed 4 participants
1
  25.0%
Month 120: Improved Number Analyzed 4 participants
0
   0.0%
Month 126: Worsened Number Analyzed 2 participants
1
  50.0%
Month 126: Unchanged Number Analyzed 2 participants
1
  50.0%
Month 126: Improved Number Analyzed 2 participants
0
   0.0%
Month 132: Worsened Number Analyzed 1 participants
1
 100.0%
Month 132: Unchanged Number Analyzed 1 participants
0
   0.0%
Month 132: Improved Number Analyzed 1 participants
0
   0.0%
22.Secondary Outcome
Title Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated.
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: meters
Change at Month 6 Number Analyzed 31 participants
2.9  (60.64)
Change at Month 18 Number Analyzed 21 participants
-21.6  (108.19)
Change at Month 24 Number Analyzed 20 participants
-15.7  (78.39)
Change at Month 30 Number Analyzed 18 participants
-44.5  (111.67)
Change at Month 36 Number Analyzed 17 participants
-63.5  (101.37)
Change at Month 42 Number Analyzed 16 participants
-95.2  (124.79)
Change at Month 48 Number Analyzed 11 participants
-110.9  (128.57)
Change at Month 54 Number Analyzed 11 participants
-127.8  (124.01)
Change at Month 66 Number Analyzed 4 participants
-63.2  (114.20)
Change at Month 72 Number Analyzed 3 participants
-139.5  (210.18)
Change at Month 78 Number Analyzed 3 participants
-94.3  (177.01)
Change at Month 84 Number Analyzed 4 participants
-100.3  (151.71)
Change at Month 90 Number Analyzed 6 participants
-97.6  (125.50)
Change at Month 96 Number Analyzed 4 participants
-118.9  (114.20)
Change at Month 102 Number Analyzed 3 participants
-82.3  (19.30)
Change at Month 108 Number Analyzed 5 participants
-141.9  (112.29)
Change at Month 114 Number Analyzed 4 participants
-166.9  (137.23)
Change at Month 120 Number Analyzed 3 participants
-184.5  (82.22)
Change at Month 132 Number Analyzed 1 participants
-289.6
23.Secondary Outcome
Title Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked < 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked >=450 meter.
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline: Level 1 Number Analyzed 30 participants
8
  26.7%
Baseline: Level 2 Number Analyzed 30 participants
10
  33.3%
Baseline: Level 3 Number Analyzed 30 participants
7
  23.3%
Baseline: Level 4 Number Analyzed 30 participants
5
  16.7%
Month 6: Level 1 Number Analyzed 30 participants
7
  23.3%
Month 6: Level 2 Number Analyzed 30 participants
9
  30.0%
Month 6: Level 3 Number Analyzed 30 participants
9
  30.0%
Month 6: Level 4 Number Analyzed 30 participants
5
  16.7%
Month 18:Level 1 Number Analyzed 21 participants
5
  23.8%
Month 18: Level 2 Number Analyzed 21 participants
5
  23.8%
Month 18: Level 3 Number Analyzed 21 participants
8
  38.1%
Month 18: Level 4 Number Analyzed 21 participants
3
  14.3%
Month 24: Level 1 Number Analyzed 20 participants
3
  15.0%
Month 24: Level 2 Number Analyzed 20 participants
7
  35.0%
Month 24: Level 3 Number Analyzed 20 participants
4
  20.0%
Month 24: Level 4 Number Analyzed 20 participants
6
  30.0%
Month 30: Level 1 Number Analyzed 18 participants
5
  27.8%
Month 30: Level 2 Number Analyzed 18 participants
6
  33.3%
Month 30: Level 3 Number Analyzed 18 participants
6
  33.3%
Month 30: Level 4 Number Analyzed 18 participants
1
   5.6%
Month 36: Level 1 Number Analyzed 17 participants
5
  29.4%
Month 36: Level 2 Number Analyzed 17 participants
4
  23.5%
Month 36: Level 3 Number Analyzed 17 participants
6
  35.3%
Month 36: Level 4 Number Analyzed 17 participants
2
  11.8%
Month 42: Level 1 Number Analyzed 16 participants
9
  56.3%
Month 42: Level 2 Number Analyzed 16 participants
2
  12.5%
Month 42: Level 3 Number Analyzed 16 participants
4
  25.0%
Month 42: Level 4 Number Analyzed 16 participants
1
   6.3%
Month 48: Level 1 Number Analyzed 11 participants
5
  45.5%
Month 48: Level 2 Number Analyzed 11 participants
1
   9.1%
Month 48: Level 3 Number Analyzed 11 participants
5
  45.5%
Month 48: Level 4 Number Analyzed 11 participants
0
   0.0%
Month 54: Level 1 Number Analyzed 11 participants
7
  63.6%
Month 54: Level 2 Number Analyzed 11 participants
2
  18.2%
Month 54: Level 3 Number Analyzed 11 participants
1
   9.1%
Month 54: Level 4 Number Analyzed 11 participants
1
   9.1%
Month 66: Level 1 Number Analyzed 4 participants
2
  50.0%
Month 66: Level 2 Number Analyzed 4 participants
1
  25.0%
Month 66: Level 3 Number Analyzed 4 participants
1
  25.0%
Month 66: Level 4 Number Analyzed 4 participants
0
   0.0%
Month 72: Level 1 Number Analyzed 3 participants
2
  66.7%
Month 72: Level 2 Number Analyzed 3 participants
0
   0.0%
Month 72: Level 3 Number Analyzed 3 participants
1
  33.3%
Month 72: Level 4 Number Analyzed 3 participants
0
   0.0%
Month 78: Level 1 Number Analyzed 3 participants
2
  66.7%
Month 78: Level 2 Number Analyzed 3 participants
0
   0.0%
Month 78: Level 3 Number Analyzed 3 participants
1
  33.3%
Month 78: Level 4 Number Analyzed 3 participants
0
   0.0%
Month 84: Level 1 Number Analyzed 4 participants
2
  50.0%
Month 84: Level 2 Number Analyzed 4 participants
2
  50.0%
Month 84: Level 3 Number Analyzed 4 participants
0
   0.0%
Month 84: Level 4 Number Analyzed 4 participants
0
   0.0%
Month 90: Level 1 Number Analyzed 6 participants
3
  50.0%
Month 90: Level 2 Number Analyzed 6 participants
1
  16.7%
Month 90: Level 3 Number Analyzed 6 participants
2
  33.3%
Month 90: Level 4 Number Analyzed 6 participants
0
   0.0%
Month 96: Level 1 Number Analyzed 4 participants
3
  75.0%
Month 96: Level 2 Number Analyzed 4 participants
1
  25.0%
Month 96: Level 3 Number Analyzed 4 participants
0
   0.0%
Month 96: Level 4 Number Analyzed 4 participants
0
   0.0%
Month 102: Level 1 Number Analyzed 3 participants
0
   0.0%
Month 102: Level 2 Number Analyzed 3 participants
2
  66.7%
Month 102: Level 3 Number Analyzed 3 participants
1
  33.3%
Month 102: Level 4 Number Analyzed 3 participants
0
   0.0%
Month 108: Level 1 Number Analyzed 5 participants
3
  60.0%
Month 108: Level 2 Number Analyzed 5 participants
2
  40.0%
Month 108: Level 3 Number Analyzed 5 participants
0
   0.0%
Month 108: Level 4 Number Analyzed 5 participants
0
   0.0%
Month 114: Level 1 Number Analyzed 4 participants
3
  75.0%
Month 114: Level 2 Number Analyzed 4 participants
1
  25.0%
Month 114: Level 3 Number Analyzed 4 participants
0
   0.0%
Month 114: Level 4 Number Analyzed 4 participants
0
   0.0%
Month 120: Level 1 Number Analyzed 3 participants
1
  33.3%
Month 120: Level 2 Number Analyzed 3 participants
2
  66.7%
Month 120: Level 3 Number Analyzed 3 participants
0
   0.0%
Month 120: Level 4 Number Analyzed 3 participants
0
   0.0%
Month 132: Level 1 Number Analyzed 1 participants
1
 100.0%
Month 132: Level 2 Number Analyzed 1 participants
0
   0.0%
Month 132: Level 3 Number Analyzed 1 participants
0
   0.0%
Month 132: Level 4 Number Analyzed 1 participants
0
   0.0%
24.Secondary Outcome
Title Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at specified visits.
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Dyspnea: Change at Month 6, Pre walk Number Analyzed 28 participants
0.3  (1.32)
Dyspnea: Change at Month 6, Post walk Number Analyzed 28 participants
0.9  (1.54)
Dyspnea: Change at Month 6,Within Visit Difference Number Analyzed 28 participants
0.6  (1.56)
Dyspnea: Change at Month 18, Pre walk Number Analyzed 19 participants
0.3  (1.11)
Dyspnea: Change at Month 18, Post walk Number Analyzed 19 participants
0.8  (1.40)
Dyspnea:Change at Month 18,Within Visit Difference Number Analyzed 19 participants
0.6  (1.93)
Dyspnea: Change at Month 24, Pre walk Number Analyzed 18 participants
0.3  (0.75)
Dyspnea: Change at Month 24, Post walk Number Analyzed 18 participants
1.5  (1.91)
Dyspnea:Change at Month 24,Within Visit Difference Number Analyzed 18 participants
1.1  (2.02)
Dyspnea: Change at Month 30, Pre walk Number Analyzed 17 participants
0.2  (0.47)
Dyspnea: Change at Month 30, Post walk Number Analyzed 17 participants
1.2  (1.27)
Dyspnea:Change at Month 30,Within Visit Difference Number Analyzed 17 participants
1.0  (1.36)
Dyspnea: Change at Month 36, Pre walk Number Analyzed 16 participants
0.1  (1.36)
Dyspnea: Change at Month 36, Post walk Number Analyzed 16 participants
-0.2  (2.68)
Dyspnea:Change at Month 36,Within Visit Difference Number Analyzed 16 participants
-0.3  (1.97)
Dyspnea: Change at Month 42, Pre walk Number Analyzed 15 participants
0.5  (0.90)
Dyspnea: Change at Month 42, Post walk Number Analyzed 15 participants
1.0  (1.45)
Dyspnea:Change at Month 42,Within Visit Difference Number Analyzed 15 participants
0.5  (1.53)
Dyspnea: Change at Month 48, Pre walk Number Analyzed 10 participants
0.6  (1.17)
Dyspnea: Change at Month 48, Post walk Number Analyzed 10 participants
1.3  (0.98)
Dyspnea:Change at Month 48,Within Visit Difference Number Analyzed 10 participants
0.8  (1.64)
Dyspnea: Change at Month 54, Pre walk Number Analyzed 11 participants
0.4  (1.56)
Dyspnea: Change at Month 54, Post walk Number Analyzed 10 participants
1.0  (1.93)
Dyspnea:Change at Month 54,Within Visit Difference Number Analyzed 10 participants
0.6  (1.91)
Dyspnea: Change at Month 66, Pre walk Number Analyzed 4 participants
1.4  (1.11)
Dyspnea: Change at Month 66, Post walk Number Analyzed 4 participants
1.5  (1.29)
Dyspnea:Change at Month 66,Within Visit Difference Number Analyzed 4 participants
0.1  (1.18)
Dyspnea: Change at Month 72, Pre walk Number Analyzed 3 participants
0.8  (1.44)
Dyspnea: Change at Month 72, Post walk Number Analyzed 3 participants
0.7  (1.15)
Dyspnea:Change at Month 72,Within Visit Difference Number Analyzed 3 participants
-0.2  (0.29)
Dyspnea: Change at Month 78, Pre walk Number Analyzed 3 participants
2.2  (2.02)
Dyspnea: Change at Month 78, Post walk Number Analyzed 3 participants
0.7  (0.58)
Dyspnea:Change at Month 78,Within Visit Difference Number Analyzed 3 participants
-1.5  (1.50)
Dyspnea: Change at Month 84, Pre walk Number Analyzed 4 participants
-0.1  (0.85)
Dyspnea: Change at Month 84, Post walk Number Analyzed 4 participants
0.5  (1.00)
Dyspnea:Change at Month 84,Within Visit Difference Number Analyzed 4 participants
0.6  (1.70)
Dyspnea: Change at Month 90, Pre walk Number Analyzed 6 participants
0.6  (0.66)
Dyspnea: Change at Month 90, Post walk Number Analyzed 6 participants
-0.8  (2.32)
Dyspnea:Change at Month 90,Within Visit Difference Number Analyzed 6 participants
-1.4  (2.20)
Dyspnea: Change at Month 96, Pre walk Number Analyzed 4 participants
1.0  (1.41)
Dyspnea: Change at Month 96, Post walk Number Analyzed 4 participants
1.3  (1.50)
Dyspnea:Change at Month 96,Within Visit Difference Number Analyzed 4 participants
0.3  (2.36)
Dyspnea: Change at Month 102, Pre walk Number Analyzed 3 participants
-0.3  (0.58)
Dyspnea: Change at Month 102, Post walk Number Analyzed 3 participants
-1.3  (4.04)
Dyspnea:Change at Month102,Within Visit Difference Number Analyzed 3 participants
-1.0  (3.46)
Dyspnea: Change at Month 108, Pre walk Number Analyzed 5 participants
1.7  (2.82)
Dyspnea: Change at Month 108, Post walk Number Analyzed 5 participants
0.7  (4.97)
Dyspnea:Change at Month108,Within Visit Difference Number Analyzed 5 participants
-1.0  (2.81)
Dyspnea: Change at Month 114, Pre walk Number Analyzed 4 participants
0.4  (1.80)
Dyspnea: Change at Month 114, Post walk Number Analyzed 4 participants
0.1  (0.63)
Dyspnea:Change at Month114,Within Visit Difference Number Analyzed 4 participants
-0.3  (1.19)
Dyspnea: Change at Month 120, Pre walk Number Analyzed 3 participants
0.3  (1.53)
Dyspnea: Change at Month 120, Post walk Number Analyzed 3 participants
-0.8  (1.04)
Dyspnea:Change at Month120,Within Visit Difference Number Analyzed 3 participants
-1.2  (2.47)
Dyspnea: Change at Month 132, Pre walk Number Analyzed 1 participants
-1.0
Dyspnea: Change at Month 132, Post walk Number Analyzed 1 participants
-1.0
Dyspnea:Change at Month132,Within Visit Difference Number Analyzed 1 participants
0.0
Fatigue: Change at Month 6, Pre walk Number Analyzed 28 participants
0.2  (1.69)
Fatigue: Change at Month 6, Post walk Number Analyzed 28 participants
0.7  (2.82)
Fatigue:Change at Month 6,Within Visit Difference Number Analyzed 28 participants
0.4  (2.92)
Fatigue: Change at Month 18, Pre walk Number Analyzed 19 participants
0.0  (2.13)
Fatigue: Change at Month 18, Post walk Number Analyzed 19 participants
0.2  (1.40)
Fatigue:Change at Month 18,Within Visit Difference Number Analyzed 19 participants
0.2  (2.51)
Fatigue: Change at Month 24, Pre walk Number Analyzed 18 participants
0.1  (1.66)
Fatigue: Change at Month 24, Post walk Number Analyzed 18 participants
1.0  (2.33)
Fatigue:Change at Month 24,Within Visit Difference Number Analyzed 18 participants
0.9  (2.97)
Fatigue: Change at Month 30, Pre walk Number Analyzed 17 participants
-0.4  (1.58)
Fatigue: Change at Month 30, Post walk Number Analyzed 17 participants
0.9  (1.65)
Fatigue:Change at Month 30,Within Visit Difference Number Analyzed 17 participants
1.3  (2.23)
Fatigue: Change at Month 36, Pre walk Number Analyzed 16 participants
-0.2  (2.29)
Fatigue: Change at Month 36, Post walk Number Analyzed 16 participants
0.8  (2.05)
Fatigue:Change at Month 36,Within Visit Difference Number Analyzed 16 participants
1.0  (2.76)
Fatigue: Change at Month 42, Pre walk Number Analyzed 15 participants
0.4  (1.76)
Fatigue: Change at Month 42, Post walk Number Analyzed 15 participants
1.6  (1.86)
Fatigue:Change at Month 42,Within Visit Difference Number Analyzed 15 participants
1.2  (2.86)
Fatigue: Change at Month 48, Pre walk Number Analyzed 10 participants
0.6  (1.26)
Fatigue: Change at Month 48, Post walk Number Analyzed 10 participants
1.5  (1.84)
Fatigue:Change at Month 48,Within Visit Difference Number Analyzed 10 participants
0.9  (2.38)
Fatigue: Change at Month 54, Pre walk Number Analyzed 11 participants
0.5  (1.57)
Fatigue: Change at Month 54, Post walk Number Analyzed 10 participants
0.5  (1.90)
Fatigue:Change at Month 54,Within Visit Difference Number Analyzed 10 participants
-0.1  (1.97)
Fatigue: Change at Month 66, Pre walk Number Analyzed 4 participants
0.3  (0.50)
Fatigue: Change at Month 66, Post walk Number Analyzed 4 participants
0.5  (2.38)
Fatigue:Change at Month 66,Within Visit Difference Number Analyzed 4 participants
0.3  (2.22)
Fatigue: Change at Month 72, Pre walk Number Analyzed 3 participants
2.0  (1.73)
Fatigue: Change at Month 72, Post walk Number Analyzed 3 participants
1.0  (1.73)
Fatigue:Change at Month 72,Within Visit Difference Number Analyzed 3 participants
-1.0  (0.00)
Fatigue: Change at Month 78, Pre walk Number Analyzed 3 participants
2.0  (2.00)
Fatigue: Change at Month 78, Post walk Number Analyzed 3 participants
1.0  (2.65)
Fatigue:Change at Month 78,Within Visit Difference Number Analyzed 3 participants
-1.0  (1.00)
Fatigue: Change at Month 84, Pre walk Number Analyzed 4 participants
0.0  (0.82)
Fatigue: Change at Month 84, Post walk Number Analyzed 4 participants
0.4  (1.11)
Fatigue:Change at Month 84,Within Visit Difference Number Analyzed 4 participants
0.4  (1.49)
Fatigue: Change at Month 90, Pre walk Number Analyzed 6 participants
1.3  (1.75)
Fatigue: Change at Month 90, Post walk Number Analyzed 6 participants
-0.3  (2.07)
Fatigue:Change at Month 90,Within Visit Difference Number Analyzed 6 participants
-1.7  (3.27)
Fatigue: Change at Month 96, Pre walk Number Analyzed 4 participants
0.8  (1.50)
Fatigue: Change at Month 96, Post walk Number Analyzed 4 participants
0.0  (0.82)
Fatigue:Change at Month 96,Within Visit Difference Number Analyzed 4 participants
-0.8  (1.71)
Fatigue: Change at Month 102, Pre walk Number Analyzed 3 participants
1.0  (2.65)
Fatigue: Change at Month 102, Post walk Number Analyzed 3 participants
-0.7  (1.53)
Fatigue:Change at Month102,Within Visit Difference Number Analyzed 3 participants
-1.7  (1.15)
Fatigue: Change at Month 108, Pre walk Number Analyzed 5 participants
1.8  (2.77)
Fatigue: Change at Month 108, Post walk Number Analyzed 5 participants
0.9  (3.54)
Fatigue:Change at Month108,Within Visit Difference Number Analyzed 5 participants
-0.9  (1.14)
Fatigue: Change at Month 114, Pre walk Number Analyzed 4 participants
1.0  (2.16)
Fatigue: Change at Month 114, Post walk Number Analyzed 4 participants
-0.1  (0.85)
Fatigue:Change at Month114,Within Visit Difference Number Analyzed 4 participants
-1.1  (1.44)
Fatigue: Change at Month 120, Pre walk Number Analyzed 3 participants
0.0  (1.00)
Fatigue: Change at Month 120, Post walk Number Analyzed 3 participants
-1.2  (0.76)
Fatigue:Change at Month120,Within Visit Difference Number Analyzed 3 participants
-1.2  (1.76)
Fatigue: Change at Month 132, Pre walk Number Analyzed 1 participants
-1.0
Fatigue: Change at Month 132, Post walk Number Analyzed 1 participants
-0.5
Fatigue:Change at Month132,Within Visit Difference Number Analyzed 1 participants
0.5
25.Secondary Outcome
Title Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132
Hide Description 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'.
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6: Worsened Number Analyzed 30 participants
5
  16.7%
Month 6: Unchanged Number Analyzed 30 participants
20
  66.7%
Month 6: Improved Number Analyzed 30 participants
5
  16.7%
Month 18: Worsened Number Analyzed 21 participants
9
  42.9%
Month 18: Unchanged Number Analyzed 21 participants
7
  33.3%
Month 18: Improved Number Analyzed 21 participants
5
  23.8%
Month 24: Worsened Number Analyzed 20 participants
6
  30.0%
Month 24: Unchanged Number Analyzed 20 participants
10
  50.0%
Month 24: Improved Number Analyzed 20 participants
4
  20.0%
Month 30: Worsened Number Analyzed 18 participants
9
  50.0%
Month 30: Unchanged Number Analyzed 18 participants
4
  22.2%
Month 30: Improved Number Analyzed 18 participants
5
  27.8%
Month 36: Worsened Number Analyzed 17 participants
8
  47.1%
Month 36: Unchanged Number Analyzed 17 participants
7
  41.2%
Month 36: Improved Number Analyzed 17 participants
2
  11.8%
Month 42: Worsened Number Analyzed 16 participants
9
  56.3%
Month 42: Unchanged Number Analyzed 16 participants
6
  37.5%
Month 42: Improved Number Analyzed 16 participants
1
   6.3%
Month 48: Worsened Number Analyzed 11 participants
7
  63.6%
Month 48: Unchanged Number Analyzed 11 participants
3
  27.3%
Month 48: Improved Number Analyzed 11 participants
1
   9.1%
Month 54: Worsened Number Analyzed 11 participants
7
  63.6%
Month 54: Unchanged Number Analyzed 11 participants
4
  36.4%
Month 54: Improved Number Analyzed 11 participants
0
   0.0%
Month 66: Worsened Number Analyzed 4 participants
3
  75.0%
Month 66: Unchanged Number Analyzed 4 participants
1
  25.0%
Month 66: Improved Number Analyzed 4 participants
0
   0.0%
Month 72: Worsened Number Analyzed 3 participants
2
  66.7%
Month 72: Unchanged Number Analyzed 3 participants
1
  33.3%
Month 72: Improved Number Analyzed 3 participants
0
   0.0%
Month 78: Worsened Number Analyzed 3 participants
2
  66.7%
Month 78: Unchanged Number Analyzed 3 participants
1
  33.3%
Month 78: Improved Number Analyzed 3 participants
0
   0.0%
Month 84: Worsened Number Analyzed 4 participants
3
  75.0%
Month 84: Unchanged Number Analyzed 4 participants
1
  25.0%
Month 84: Improved Number Analyzed 4 participants
0
   0.0%
Month 90: Worsened Number Analyzed 6 participants
4
  66.7%
Month 90: Unchanged Number Analyzed 6 participants
1
  16.7%
Month 90: Improved Number Analyzed 6 participants
1
  16.7%
Month 96: Worsened Number Analyzed 4 participants
3
  75.0%
Month 96: Unchanged Number Analyzed 4 participants
1
  25.0%
Month 96: Improved Number Analyzed 4 participants
0
   0.0%
Month 102: Worsened Number Analyzed 3 participants
2
  66.7%
Month 102: Unchanged Number Analyzed 3 participants
1
  33.3%
Month 102: Improved Number Analyzed 3 participants
0
   0.0%
Month 108: Worsened Number Analyzed 5 participants
4
  80.0%
Month 108: Unchanged Number Analyzed 5 participants
1
  20.0%
Month 108: Improved Number Analyzed 5 participants
0
   0.0%
Month 114: Worsened Number Analyzed 4 participants
3
  75.0%
Month 114: Unchanged Number Analyzed 4 participants
1
  25.0%
Month 114: Improved Number Analyzed 4 participants
0
   0.0%
Month 120: Worsened Number Analyzed 3 participants
3
 100.0%
Month 120: Unchanged Number Analyzed 3 participants
0
   0.0%
Month 120: Improved Number Analyzed 3 participants
0
   0.0%
Month 132: Worsened Number Analyzed 1 participants
1
 100.0%
Month 132: Unchanged Number Analyzed 1 participants
0
   0.0%
Month 132: Improved Number Analyzed 1 participants
0
   0.0%
26.Secondary Outcome
Title Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
Hide Description KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status.
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Summary Score: Change at Month 6 Number Analyzed 31 participants
-2.12  (12.423)
Overall Summary Score: Change at Month 18 Number Analyzed 28 participants
-4.58  (18.926)
Overall Summary Score: Change at Month 24 Number Analyzed 22 participants
-2.94  (16.247)
Overall Summary Score: Change at Month 30 Number Analyzed 20 participants
-5.41  (17.695)
Overall Summary Score: Change at Month 36 Number Analyzed 19 participants
-6.86  (18.525)
Overall Summary Score: Change at Month 42 Number Analyzed 17 participants
-12.76  (23.646)
Overall Summary Score: Change at Month 48 Number Analyzed 12 participants
-13.22  (24.893)
Overall Summary Score: Change at Month 54 Number Analyzed 13 participants
-14.99  (23.688)
Overall Summary Score: Change at Month 66 Number Analyzed 6 participants
-1.77  (30.476)
Overall Summary Score: Change at Month 72 Number Analyzed 7 participants
0.41  (23.317)
Overall Summary Score: Change at Month 78 Number Analyzed 7 participants
-3.60  (24.231)
Overall Summary Score: Change at Month 84 Number Analyzed 6 participants
-3.72  (32.770)
Overall Summary Score: Change at Month 90 Number Analyzed 7 participants
-0.28  (30.296)
Overall Summary Score: Change at Month 96 Number Analyzed 4 participants
-17.84  (47.842)
Overall Summary Score: Change at Month 102 Number Analyzed 4 participants
-12.63  (40.904)
Overall Summary Score: Change at Month 108 Number Analyzed 4 participants
-1.19  (35.375)
Overall Summary Score: Change at Month 114 Number Analyzed 4 participants
-2.99  (37.897)
Overall Summary Score: Change at Month 120 Number Analyzed 2 participants
-35.55  (9.023)
Overall Summary Score: Change at Month 126 Number Analyzed 2 participants
-39.32  (8.102)
Overall Summary Score: Change at Month 132 Number Analyzed 1 participants
-40.10
Clinical Summary Score: Change at Month 6 Number Analyzed 31 participants
-3.00  (11.650)
Clinical Summary Score: Change at Month 18 Number Analyzed 28 participants
-6.66  (17.340)
Clinical Summary Score: Change at Month 24 Number Analyzed 22 participants
-2.87  (15.875)
Clinical Summary Score: Change at Month 30 Number Analyzed 20 participants
-7.80  (17.497)
Clinical Summary Score: Change at Month 36 Number Analyzed 19 participants
-9.53  (17.700)
Clinical Summary Score: Change at Month 42 Number Analyzed 17 participants
-17.05  (22.804)
Clinical Summary Score: Change at Month 48 Number Analyzed 12 participants
-15.67  (24.854)
Clinical Summary Score: Change at Month 54 Number Analyzed 13 participants
-16.90  (21.295)
Clinical Summary Score: Change at Month 66 Number Analyzed 6 participants
-3.45  (27.219)
Clinical Summary Score: Change at Month 72 Number Analyzed 7 participants
-1.82  (21.558)
Clinical Summary Score: Change at Month 78 Number Analyzed 7 participants
-7.13  (22.422)
Clinical Summary Score: Change at Month 84 Number Analyzed 6 participants
-6.53  (29.881)
Clinical Summary Score: Change at Month 90 Number Analyzed 7 participants
-2.47  (24.198)
Clinical Summary Score: Change at Month 96 Number Analyzed 4 participants
-19.27  (42.768)
Clinical Summary Score: Change at Month 102 Number Analyzed 4 participants
-15.10  (31.690)
Clinical Summary Score: Change at Month 108 Number Analyzed 4 participants
-3.26  (27.764)
Clinical Summary Score: Change at Month 114 Number Analyzed 4 participants
-4.69  (32.213)
Clinical Summary Score: Change at Month 120 Number Analyzed 2 participants
-42.45  (11.417)
Clinical Summary Score: Change at Month 126 Number Analyzed 2 participants
-38.02  (14.731)
Clinical Summary Score: Change at Month 132 Number Analyzed 1 participants
-40.63
27.Secondary Outcome
Title Number of Participants With Abnormalities in Echocardiography
Hide Description Echocardiography abnormalities included: absent respiratory variation of inferior vena cava, any valve thickening, aortic valve thickening, decreased respiratory variation of inferior vena cava, dilated inferior vena cava, E deceleration time less than or equal to (<=) 150 millisecond, E wave/A Wave (E/A) ratio >=2, ejection fraction < 50%, isovolumic relaxation time (IVRT) <=70 millisecond, left ventricular posterior wall thickness >=13 millimeter (mm), left ventricular septal thickness >= 13 mm, mitral valve thickening, pericardial effusion, pulmonary valve thickening, right ventricular thickness >=7 mm, tricuspid valve thickening, ratio between early mitral inflow velocity and mitral annular early diastolic velocity (e/e') Lateral greater than (>) 15, e/e' Septal >15.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
31
 100.0%
28.Secondary Outcome
Title Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126
Hide Description Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage.
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Troponin I: Change at Month 6 Number Analyzed 31 participants
-0.016  (0.0533)
Troponin I: Change at Month 18 Number Analyzed 27 participants
0.032  (0.1307)
Troponin I: Change at Month 24 Number Analyzed 22 participants
0.023  (0.0986)
Troponin I: Change at Month 30 Number Analyzed 20 participants
0.022  (0.1038)
Troponin I: Change at Month 36 Number Analyzed 19 participants
0.029  (0.1099)
Troponin I: Change at Month 42 Number Analyzed 17 participants
0.042  (0.1409)
Troponin I: Change at Month 48 Number Analyzed 12 participants
0.058  (0.1409)
Troponin I: Change at Month 54 Number Analyzed 13 participants
0.042  (0.1226)
Troponin I: Change at Month 66 Number Analyzed 6 participants
-0.012  (0.0133)
Troponin I: Change at Month 72 Number Analyzed 4 participants
-0.010  (0.0183)
Troponin I: Change at Month 78 Number Analyzed 3 participants
-0.013  (0.0208)
Troponin I: Change at Month 84 Number Analyzed 4 participants
-0.008  (0.0096)
Troponin I: Change at Month 90 Number Analyzed 7 participants
-0.003  (0.0293)
Troponin I: Change at Month 96 Number Analyzed 4 participants
-0.008  (0.0150)
Troponin I: Change at Month 102 Number Analyzed 4 participants
-0.010  (0.0356)
Troponin I: Change at Month 108 Number Analyzed 5 participants
0.000  (0.0071)
Troponin I: Change at Month 114 Number Analyzed 4 participants
0.000  (0.0271)
Troponin I: Change at Month 120 Number Analyzed 2 participants
0.000  (0.0141)
Troponin I: Change at Month 126 Number Analyzed 2 participants
0.005  (0.0354)
Troponin T: Change at Month 6 Number Analyzed 29 participants
-0.0007  (0.01710)
Troponin T: Change at Month 18 Number Analyzed 27 participants
0.0271  (0.07429)
Troponin T: Change at Month 24 Number Analyzed 22 participants
0.0132  (0.03286)
Troponin T: Change at Month 30 Number Analyzed 20 participants
0.0166  (0.02227)
Troponin T: Change at Month 36 Number Analyzed 19 participants
0.0205  (0.03049)
Troponin T: Change at Month 42 Number Analyzed 17 participants
0.0329  (0.05665)
Troponin T: Change at Month 48 Number Analyzed 10 participants
0.0510  (0.09562)
Troponin T: Change at Month 54 Number Analyzed 13 participants
0.0562  (0.13264)
Troponin T: Change at Month 66 Number Analyzed 6 participants
0.0050  (0.02588)
Troponin T: Change at Month 72 Number Analyzed 4 participants
-0.0055  (0.01714)
Troponin T: Change at Month 78 Number Analyzed 3 participants
0.0000  (0.01732)
Troponin T: Change at Month 84 Number Analyzed 4 participants
-0.0003  (0.01415)
Troponin T: Change at Month 90 Number Analyzed 7 participants
0.0026  (0.00962)
Troponin T: Change at Month 96 Number Analyzed 3 participants
-0.0037  (0.00551)
Troponin T: Change at Month 102 Number Analyzed 4 participants
0.0098  (0.01461)
Troponin T: Change at Month 108 Number Analyzed 5 participants
0.0100  (0.00707)
Troponin T: Change at Month114 Number Analyzed 4 participants
0.0100  (0.00816)
Troponin T: Change at Month 120 Number Analyzed 2 participants
0.0150  (0.02121)
Troponin T: Change at Month 126 Number Analyzed 1 participants
0.0000
29.Secondary Outcome
Title Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126
Hide Description NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).
Time Frame Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. "Number analyzed" =participants evaluable for this outcome measure at specified time point.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Change at Month 6 Number Analyzed 31 participants
66.0  (2164.66)
Change at Month 18 Number Analyzed 27 participants
492.0  (2455.65)
Change at Month 24 Number Analyzed 22 participants
211.5  (2119.01)
Change at Month 30 Number Analyzed 20 participants
701.8  (2423.16)
Change at Month 36 Number Analyzed 19 participants
1063.5  (2813.85)
Change at Month 42 Number Analyzed 17 participants
2510.2  (5143.47)
Change at Month 48 Number Analyzed 10 participants
3761.2  (7892.80)
Change at Month 54 Number Analyzed 12 participants
1668.1  (2677.27)
Change at Month 66 Number Analyzed 6 participants
433.3  (493.76)
Change at Month 72 Number Analyzed 4 participants
625.5  (471.41)
Change at Month 78 Number Analyzed 3 participants
707.7  (236.53)
Change at Month 84 Number Analyzed 4 participants
348.5  (700.98)
Change at Month 90 Number Analyzed 7 participants
283.7  (971.53)
Change at Month 96 Number Analyzed 3 participants
1453.0  (2193.75)
Change at Month 102 Number Analyzed 4 participants
1439.0  (2032.43)
Change at Month 108 Number Analyzed 5 participants
346.4  (1279.58)
Change at Month 114 Number Analyzed 3 participants
465.7  (790.48)
Change at Month 120 Number Analyzed 2 participants
1232.0  (667.51)
Change at Month 126 Number Analyzed 1 participants
1249.0
30.Secondary Outcome
Title Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events
Hide Description All cause hospitalization was defined as any serious adverse event, which resulted in hospitalization. Cardiac-related hospitalization was any hospitalization meeting the following criteria: cardiac disorders or AE preferred term as chest discomfort, chest pain, death, cerebrovascular accident, embolic stroke, disease progression.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
All-cause Hospitalization
27
  87.1%
Cardiac Related Hospitalization
18
  58.1%
31.Secondary Outcome
Title Time to All-cause Mortality and Cardiac-Related Mortality
Hide Description Time to death for all participants with a death date in Clinical Database, or censored at the last dose date + 28 days for those participants who were alive at the end of the study is reported.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: years
All-Cause Mortality
4.1
(1.9 to 5.4)
Cardiac-related mortality
5.9 [1] 
(3.0 to NA)
[1]
Due to very less number of events upper limit of 95% CI could not be estimated, hence not provided.
32.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with AEs
31
 100.0%
Participants with SAEs
29
  93.5%
33.Secondary Outcome
Title Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events. Relatedness to study drug was assessed by the investigator as (Yes/No).
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
Participant with AEs
7
  22.6%
Participant with SAEs
4
  12.9%
34.Secondary Outcome
Title Number of Participants With Clinically Significant Physical Examination Findings
Hide Description Physical examination included examination of general appearance, endocrine, head and neck, cardiovascular, eyes, abdomen, ears, skin, nose, musculoskeletal, throat, neurological, respiratory, immunologic/allergies, genitourinary, hematologic/lymphatic. Clinical significance of any physical examination finding was judged by investigator.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
19
  67.9%
35.Secondary Outcome
Title Number of Participants With Any Concomitant Medications
Hide Description Number of participants who used medication other than study drug were reported.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
31
 100.0%
36.Secondary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Hide Description ECG parameters included PR interval (millisecond), RR interval (millisecond), QRS interval (millisecond), QT and QTc interval (millisecond) and heart rate (beats per minute). Clinical significance of any ECG finding was judged by investigator.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.2%
37.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities
Hide Description Laboratory parameters included hematology and biochemistry: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, gamma glutamyl transferase (GGT), creatinine, total bilirubin, international normalized ratio (INR), troponin I, troponin T, prothrombin time, sodium, globulin potassium, chloride, bicarbonate, cholesterol, calcium, uric acid, inorganic phosphorous, thyroid-stimulating hormone, glucose, total thyroxine (T4), free T4, total proteins, prealbumin (transthyretin), albumin, hemoglobin, platelets, hematocrit, white blood cell count, red blood cell count, neutrophils, packed cell volume, lymphocytes, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, eosinophils, mean corpuscular hemoglobin concentration, basophils, retinol-binding protein, Urinalysis: bilirubin, pH, blood (free Hb), protein, nitrite, glucose, urobilinogen, ketones, specific gravity.
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description:
Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
27
  87.1%
Time Frame Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population evaluated.
 
Arm/Group Title Tafamidis 20 mg
Hide Arm/Group Description Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries.
All-Cause Mortality
Tafamidis 20 mg
Affected / at Risk (%)
Total   23/31 (74.19%) 
Hide Serious Adverse Events
Tafamidis 20 mg
Affected / at Risk (%)
Total   29/31 (93.55%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/31 (3.23%) 
HEPARIN-INDUCED THROMBOCYTOPENIA * 1  1/31 (3.23%) 
Cardiac disorders   
ARRHYTHMIA * 1  1/31 (3.23%) 
ATRIAL FIBRILLATION * 1  1/31 (3.23%) 
ATRIAL FLUTTER * 1  1/31 (3.23%) 
ATRIAL TACHYCARDIA * 1  2/31 (6.45%) 
ATRIOVENTRICULAR BLOCK * 1  1/31 (3.23%) 
ATRIOVENTRICULAR BLOCK COMPLETE * 1  1/31 (3.23%) 
CARDIAC AMYLOIDOSIS * 1  1/31 (3.23%) 
CARDIAC ARREST * 1  1/31 (3.23%) 
CARDIAC FAILURE * 1  6/31 (19.35%) 
CARDIAC FAILURE ACUTE * 1  1/31 (3.23%) 
CARDIAC FAILURE CHRONIC * 1  1/31 (3.23%) 
CARDIAC FAILURE CONGESTIVE * 1  9/31 (29.03%) 
CARDIO-RESPIRATORY ARREST * 1  1/31 (3.23%) 
CARDIOGENIC SHOCK * 1  1/31 (3.23%) 
LEFT VENTRICULAR FAILURE * 1  1/31 (3.23%) 
SUPRAVENTRICULAR TACHYCARDIA * 1  1/31 (3.23%) 
Congenital, familial and genetic disorders   
FAMILIAL AMYLOIDOSIS * 1  4/31 (12.90%) 
Gastrointestinal disorders   
ABDOMINAL PAIN UPPER * 1  1/31 (3.23%) 
FAECALOMA * 1  2/31 (6.45%) 
GASTROINTESTINAL HAEMORRHAGE * 1  1/31 (3.23%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  1/31 (3.23%) 
OESOPHAGEAL MOTILITY DISORDER * 1  1/31 (3.23%) 
PANCREATITIS * 1  1/31 (3.23%) 
General disorders   
ASTHENIA * 1  2/31 (6.45%) 
CHEST DISCOMFORT * 1  2/31 (6.45%) 
CHEST PAIN * 1  3/31 (9.68%) 
DEATH * 1  1/31 (3.23%) 
OEDEMA PERIPHERAL * 1  1/31 (3.23%) 
Infections and infestations   
BACTERIAL SEPSIS * 1  1/31 (3.23%) 
CELLULITIS * 1  3/31 (9.68%) 
DEVICE RELATED INFECTION * 1  1/31 (3.23%) 
INFLUENZA * 1  2/31 (6.45%) 
KLEBSIELLA BACTERAEMIA * 1  1/31 (3.23%) 
PNEUMONIA * 1  2/31 (6.45%) 
SEPSIS * 1  1/31 (3.23%) 
STAPHYLOCOCCAL INFECTION * 1  1/31 (3.23%) 
UROSEPSIS * 1  1/31 (3.23%) 
Injury, poisoning and procedural complications   
ACCIDENTAL OVERDOSE * 1  1/31 (3.23%) 
CARDIAC CONTUSION * 1  1/31 (3.23%) 
CERVICAL VERTEBRAL FRACTURE * 1  1/31 (3.23%) 
FALL * 1  6/31 (19.35%) 
FEMUR FRACTURE * 1  1/31 (3.23%) 
PELVIC FRACTURE * 1  1/31 (3.23%) 
RIB FRACTURE * 1  1/31 (3.23%) 
SKIN LACERATION * 1  1/31 (3.23%) 
SPINAL COMPRESSION FRACTURE * 1  1/31 (3.23%) 
SUBDURAL HAEMATOMA * 1  1/31 (3.23%) 
UPPER LIMB FRACTURE * 1  1/31 (3.23%) 
Investigations   
WEIGHT INCREASED * 1  1/31 (3.23%) 
Metabolism and nutrition disorders   
DEHYDRATION * 1  3/31 (9.68%) 
FAILURE TO THRIVE * 1  1/31 (3.23%) 
GOUT * 1  2/31 (6.45%) 
HYPERKALAEMIA * 1  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders   
OSTEOPOROSIS * 1  1/31 (3.23%) 
PAIN IN EXTREMITY * 1  1/31 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
METASTASES TO BONE * 1  1/31 (3.23%) 
METASTATIC MALIGNANT MELANOMA * 1  1/31 (3.23%) 
PROSTATE CANCER * 1  1/31 (3.23%) 
Nervous system disorders   
CEREBROVASCULAR ACCIDENT * 1  1/31 (3.23%) 
DEMENTIA * 1  1/31 (3.23%) 
EMBOLIC STROKE * 1  1/31 (3.23%) 
METABOLIC ENCEPHALOPATHY * 1  1/31 (3.23%) 
PARKINSONISM * 1  1/31 (3.23%) 
PRESYNCOPE * 1  2/31 (6.45%) 
SUBARACHNOID HAEMORRHAGE * 1  1/31 (3.23%) 
SYNCOPE * 1  1/31 (3.23%) 
Psychiatric disorders   
HALLUCINATION * 1  1/31 (3.23%) 
MENTAL STATUS CHANGES * 1  1/31 (3.23%) 
CONFUSIONAL STATE * 1  1/31 (3.23%) 
Renal and urinary disorders   
ACUTE KIDNEY INJURY * 1  2/31 (6.45%) 
END STAGE RENAL DISEASE * 1  1/31 (3.23%) 
POLYURIA * 1  1/31 (3.23%) 
RENAL FAILURE * 1  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
LARYNGEAL OEDEMA * 1  1/31 (3.23%) 
LUNG DISORDER * 1  1/31 (3.23%) 
PLEURAL EFFUSION * 1  1/31 (3.23%) 
PULMONARY EMBOLISM * 1  1/31 (3.23%) 
Skin and subcutaneous tissue disorders   
SKIN ULCER * 1  1/31 (3.23%) 
Vascular disorders   
VARICOSE VEIN RUPTURED * 1  1/31 (3.23%) 
1
Term from vocabulary, MedDRA 22.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Tafamidis 20 mg
Affected / at Risk (%)
Total   30/31 (96.77%) 
Blood and lymphatic system disorders   
ANAEMIA * 1  4/31 (12.90%) 
Cardiac disorders   
ATRIAL FIBRILLATION * 1  5/31 (16.13%) 
CARDIAC FAILURE * 1  3/31 (9.68%) 
CARDIAC FAILURE CONGESTIVE * 1  3/31 (9.68%) 
PALPITATIONS * 1  3/31 (9.68%) 
ATRIAL FLUTTER * 1  2/31 (6.45%) 
Congenital, familial and genetic disorders   
FAMILIAL AMYLOIDOSIS * 1  2/31 (6.45%) 
Endocrine disorders   
HYPOTHYROIDISM * 1  3/31 (9.68%) 
Eye disorders   
CATARACT * 1  3/31 (9.68%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION * 1  2/31 (6.45%) 
ABDOMINAL PAIN * 1  2/31 (6.45%) 
CONSTIPATION * 1  11/31 (35.48%) 
DIARRHOEA * 1  5/31 (16.13%) 
GASTROOESOPHAGEAL REFLUX DISEASE * 1  2/31 (6.45%) 
LARGE INTESTINE POLYP * 1  2/31 (6.45%) 
NAUSEA * 1  3/31 (9.68%) 
General disorders   
ASTHENIA * 1  4/31 (12.90%) 
CHEST PAIN * 1  2/31 (6.45%) 
GAIT DISTURBANCE * 1  2/31 (6.45%) 
OEDEMA PERIPHERAL * 1  5/31 (16.13%) 
PERIPHERAL SWELLING * 1  2/31 (6.45%) 
PYREXIA * 1  3/31 (9.68%) 
FATIGUE * 1  10/31 (32.26%) 
Infections and infestations   
BRONCHITIS * 1  3/31 (9.68%) 
CELLULITIS * 1  3/31 (9.68%) 
EAR INFECTION * 1  2/31 (6.45%) 
NASOPHARYNGITIS * 1  2/31 (6.45%) 
PNEUMONIA * 1  4/31 (12.90%) 
STAPHYLOCOCCAL INFECTION * 1  2/31 (6.45%) 
UPPER RESPIRATORY TRACT INFECTION * 1  5/31 (16.13%) 
URINARY TRACT INFECTION * 1  6/31 (19.35%) 
Injury, poisoning and procedural complications   
CONTUSION * 1  4/31 (12.90%) 
FALL * 1  13/31 (41.94%) 
HUMERUS FRACTURE * 1  2/31 (6.45%) 
RIB FRACTURE * 1  2/31 (6.45%) 
SKIN ABRASION * 1  3/31 (9.68%) 
SKIN LACERATION * 1  7/31 (22.58%) 
Investigations   
BLOOD THYROID STIMULATING HORMONE INCREASED * 1  2/31 (6.45%) 
BRAIN NATRIURETIC PEPTIDE INCREASED * 1  2/31 (6.45%) 
INTERNATIONAL NORMALISED RATIO INCREASED * 1  3/31 (9.68%) 
PROTHROMBIN TIME PROLONGED * 1  2/31 (6.45%) 
VENOUS PRESSURE JUGULAR INCREASED * 1  2/31 (6.45%) 
WEIGHT DECREASED * 1  6/31 (19.35%) 
WEIGHT INCREASED * 1  3/31 (9.68%) 
Metabolism and nutrition disorders   
DECREASED APPETITE * 1  2/31 (6.45%) 
DEHYDRATION * 1  7/31 (22.58%) 
FAILURE TO THRIVE * 1  3/31 (9.68%) 
FLUID OVERLOAD * 1  3/31 (9.68%) 
HYPOKALAEMIA * 1  4/31 (12.90%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA * 1  9/31 (29.03%) 
BACK PAIN * 1  11/31 (35.48%) 
MUSCLE SPASMS * 1  3/31 (9.68%) 
MUSCULOSKELETAL CHEST PAIN * 1  2/31 (6.45%) 
MUSCULOSKELETAL PAIN * 1  3/31 (9.68%) 
NECK PAIN * 1  2/31 (6.45%) 
PAIN IN EXTREMITY * 1  7/31 (22.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
MALIGNANT MELANOMA * 1  2/31 (6.45%) 
Nervous system disorders   
BALANCE DISORDER * 1  5/31 (16.13%) 
DIZZINESS * 1  5/31 (16.13%) 
DIZZINESS POSTURAL * 1  2/31 (6.45%) 
HEADACHE * 1  3/31 (9.68%) 
MEMORY IMPAIRMENT * 1  2/31 (6.45%) 
SYNCOPE * 1  3/31 (9.68%) 
TREMOR * 1  3/31 (9.68%) 
Psychiatric disorders   
DEPRESSION * 1  3/31 (9.68%) 
MENTAL STATUS CHANGES * 1  2/31 (6.45%) 
INSOMNIA * 1  3/31 (9.68%) 
Renal and urinary disorders   
HAEMATURIA * 1  4/31 (12.90%) 
Respiratory, thoracic and mediastinal disorders   
COUGH * 1  4/31 (12.90%) 
DYSPNOEA * 1  9/31 (29.03%) 
EPISTAXIS * 1  3/31 (9.68%) 
PLEURAL EFFUSION * 1  2/31 (6.45%) 
PRODUCTIVE COUGH * 1  3/31 (9.68%) 
SINUS CONGESTION * 1  2/31 (6.45%) 
UPPER-AIRWAY COUGH SYNDROME * 1  2/31 (6.45%) 
WHEEZING * 1  2/31 (6.45%) 
Skin and subcutaneous tissue disorders   
ECCHYMOSIS * 1  2/31 (6.45%) 
HYPERHIDROSIS * 1  2/31 (6.45%) 
PRURITUS * 1  3/31 (9.68%) 
RASH * 1  4/31 (12.90%) 
SKIN ULCER * 1  3/31 (9.68%) 
URTICARIA * 1  2/31 (6.45%) 
Vascular disorders   
HYPOTENSION * 1  4/31 (12.90%) 
ORTHOSTATIC HYPOTENSION * 1  2/31 (6.45%) 
1
Term from vocabulary, MedDRA 22.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00935012    
Other Study ID Numbers: FX1B-303
B3461026 ( Other Identifier: Alias Study Number )
First Submitted: July 6, 2009
First Posted: July 8, 2009
Results First Submitted: October 26, 2020
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021