Trial Outcomes & Findings for Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy (NCT NCT00935012)

Last Updated: 2021-01-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

Month 12

Results posted on

2021-01-05

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	Tafamidis 20 mg 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 Study STARTED	31
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Tafamidis 20 mg 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 Study Death	19
Overall Study Withdrawal by Subject	3
Overall Study Other	5
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tafamidis 20 mg n=31 Participants 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.
Age, Continuous	77.6 years STANDARD_DEVIATION 4.89 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=5 Participants
Race/Ethnicity, Customized Afro-caribbean	1 Participants n=5 Participants
Race/Ethnicity, Customized African American	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Markedly Improved	0 percentage of participants Interval 0.0 to 11.2
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Moderately Improved	16.1 percentage of participants Interval 5.5 to 33.7
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Mildly Improved	9.7 percentage of participants Interval 2.0 to 25.8
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Unchanged	51.6 percentage of participants Interval 33.1 to 69.8
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Mildly Worsened	12.9 percentage of participants Interval 3.6 to 29.8
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Moderately Worsened	9.7 percentage of participants Interval 2.0 to 25.8
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 Markedly Worsened	0 percentage of participants Interval 0.0 to 11.2

PRIMARY outcome

Timeframe: Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Markedly Improved	0 percentage of participants Interval 0.0 to 26.5
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Moderately Improved	8.3 percentage of participants Interval 0.2 to 38.5
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Mildly Improved	8.3 percentage of participants Interval 0.2 to 38.5
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Unchanged	50.0 percentage of participants Interval 21.1 to 78.9
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Mildly Worsened	16.7 percentage of participants Interval 2.1 to 48.4
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Moderately Worsened	16.7 percentage of participants Interval 2.1 to 48.4
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 Markedly Worsened	0 percentage of participants Interval 0.0 to 26.5

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline CLASS I	4 Participants
Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline CLASS II	26 Participants
Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline CLASS III	1 Participants
Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline CLASS IV	0 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 Worsened	7 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 Unchanged	20 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 Improved	4 Participants

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=12 Participants 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.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 Worsened	8 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 Unchanged	3 Participants
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 Improved	1 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=30 Participants 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.
Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Baseline	363.7 meters Standard Deviation 130.80
Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Change at Month 12	-11.2 meters Standard Deviation 76.39

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=8 Participants 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.
Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60	-121.4 meters Standard Deviation 145.82

PRIMARY outcome

Timeframe: Month 12

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=28 Participants 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.
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Level 2	7 Participants
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Level 3	7 Participants
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Level 4	6 Participants
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Level 1	8 Participants

PRIMARY outcome

Timeframe: Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=8 Participants 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.
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Level 1	4 Participants
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Level 2	3 Participants
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Level 3	0 Participants
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Level 4	1 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=28 Participants 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.
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Dyspnea: Baseline, Pre walk	0.6 units on a scale Standard Deviation 0.72
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Dyspnea: Baseline, Post walk	2.5 units on a scale Standard Deviation 1.94
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Dyspnea: Baseline, Within Visit Difference	1.9 units on a scale Standard Deviation 1.94
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Dyspnea: Change at Month 12, Pre walk	0.6 units on a scale Standard Deviation 1.61
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Dyspnea: Change at Month 12, Post walk	1.2 units on a scale Standard Deviation 1.60
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Dyspnea:Change at Month 12,Within Visit Difference	0.6 units on a scale Standard Deviation 1.70
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Fatigue: Baseline, Pre-walk	0.9 units on a scale Standard Deviation 1.27
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Fatigue: Baseline, Post-walk	2.4 units on a scale Standard Deviation 2.06
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Fatigue: Baseline, Within Visit Difference	1.4 units on a scale Standard Deviation 2.51
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Fatigue: Change at Month 12, Pre Walk	0.5 units on a scale Standard Deviation 2.20
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Fatigue: Change at Month 12, Post-Walk	0.9 units on a scale Standard Deviation 1.98
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 Fatigue:Change at Month 12,Within Visit Difference	0.4 units on a scale Standard Deviation 2.20

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=8 Participants 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.
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 Dyspnea: Change at Month 60, Pre walk	0.8 units on a scale Standard Deviation 1.41
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 Dyspnea: Change at Month 60, Post walk	0.8 units on a scale Standard Deviation 1.60
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 Dyspnea:Change at Month 60,Within Visit Difference	0.1 units on a scale Standard Deviation 1.94
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 Fatigue: Change at Month 60, Pre walk	0.1 units on a scale Standard Deviation 0.35
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 Fatigue: Change at Month 60, Post walk	0.4 units on a scale Standard Deviation 1.51
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 Fatigue:Change at Month 60,Within Visit Difference	0.3 units on a scale Standard Deviation 1.49

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

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'.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=28 Participants 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.
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Worsened	7 Participants
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Unchanged	16 Participants
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 Improved	5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

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'.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=8 Participants 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.
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Worsened	5 Participants
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Unchanged	3 Participants
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 Improved	0 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 Overall Summary Score: Baseline	72.21 units on a scale Standard Deviation 18.974
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 Overall Summary Score: Change at Month 12	-4.54 units on a scale Standard Deviation 12.724
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 Clinical Summary Score: Baseline	74.79 units on a scale Standard Deviation 19.296
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 Clinical Summary Score: Change at Month 12	-5.60 units on a scale Standard Deviation 13.792

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=11 Participants 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.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60 Overall Summary Score: Change at Month 60	-12.93 units on a scale Standard Deviation 29.306
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60 Clinical Summary Score: Change at Month 60	-18.12 units on a scale Standard Deviation 29.432

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 Troponin I: Baseline	0.132 nanogram per milliliter Standard Deviation 0.0627
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 Troponin I: Change at Month 12	0.016 nanogram per milliliter Standard Deviation 0.0652
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 Troponin T: Baseline	0.0448 nanogram per milliliter Standard Deviation 0.03402
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 Troponin T: Change at Month 12	0.0110 nanogram per milliliter Standard Deviation 0.02239

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=11 Participants 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.
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60 Troponin T: Change at Month 60	0.026 nanogram per milliliter Standard Deviation 0.0937
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60 Troponin I: Change at Month 60	0.0810 nanogram per milliliter Standard Deviation 0.17779

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: 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.

NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular \[LV\] wall stress).

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12 Baseline	4526.1 nanogram per milliliter Standard Deviation 3814.21
Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12 Change at Month 12	818.3 nanogram per milliliter Standard Deviation 3133.86

PRIMARY outcome

Timeframe: Baseline, Month 60

Population: 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.

NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=11 Participants 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.
Change From Baseline in Serum Levels of Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) at Month 60	5127.6 nanogram per milliliter Standard Deviation 10598.94

SECONDARY outcome

Timeframe: Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
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 Month 6: Markedly Improved	9.7 percentage of participants Interval 2.0 to 25.8
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 Month 6: Moderately Improved	3.2 percentage of participants Interval 0.1 to 16.7
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 Month 6: Mildly Improved	9.7 percentage of participants Interval 2.0 to 25.8
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 Month 6: Unchanged	51.6 percentage of participants Interval 33.1 to 69.8
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 Month 6: Mildly Worsened	25.8 percentage of participants Interval 11.9 to 44.6
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 Month 6: Moderately Worsened	0 percentage of participants Interval 0.0 to 11.2
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 Month 6: Markedly Worsened	0 percentage of participants Interval 0.0 to 11.2
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 Month 18: Markedly Improved	7.1 percentage of participants Interval 0.9 to 23.5
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 Month 18: Moderately Improved	10.7 percentage of participants Interval 2.3 to 28.2
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 Month 18: Mildly Improved	17.9 percentage of participants Interval 6.1 to 36.9
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 Month 18: Unchanged	25.0 percentage of participants Interval 10.7 to 44.9
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 Month 18: Mildly Worsened	17.9 percentage of participants Interval 6.1 to 36.9
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 Month 18: Moderately Worsened	10.7 percentage of participants Interval 2.3 to 28.2
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 Month 18: Markedly Worsened	10.7 percentage of participants Interval 2.3 to 28.2
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 Month 24: Markedly Improved	9.1 percentage of participants Interval 1.1 to 29.2
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 Month 24: Moderately Improved	18.2 percentage of participants Interval 5.2 to 40.3
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 Month 24: Mildly Improved	13.6 percentage of participants Interval 2.9 to 34.9
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 Month 24: Unchanged	27.3 percentage of participants Interval 10.7 to 50.2
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 Month 24: Mildly Worsened	22.7 percentage of participants Interval 7.8 to 45.4
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 Month 24: Moderately Worsened	4.5 percentage of participants Interval 0.1 to 22.8
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 Month 24: Markedly Worsened	4.5 percentage of participants Interval 0.1 to 22.8
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 Month 30: Markedly Improved	0 percentage of participants Interval 0.0 to 16.8
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 Month 30: Moderately Improved	10.0 percentage of participants Interval 1.2 to 31.7
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 Month 30: Mildly Improved	5.0 percentage of participants Interval 0.1 to 24.9
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 Month 30: Unchanged	40.0 percentage of participants Interval 19.1 to 63.9
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 Month 30: Mildly Worsened	25.0 percentage of participants Interval 8.7 to 49.1
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 Month 30: Moderately Worsened	20.0 percentage of participants Interval 5.7 to 43.7
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 Month 30: Markedly Worsened	0 percentage of participants Interval 0.0 to 16.8
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 Month 36: Markedly Improved	0 percentage of participants Interval 0.0 to 17.6
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 Month 36: Moderately Improved	0 percentage of participants Interval 0.0 to 17.6
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 Month 36: Mildly Improved	5.3 percentage of participants Interval 0.1 to 26.0
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 Month 36: Unchanged	47.4 percentage of participants Interval 24.4 to 71.1
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 Month 36: Mildly Worsened	26.3 percentage of participants Interval 9.1 to 51.2
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 Month 36: Moderately Worsened	21.1 percentage of participants Interval 6.1 to 45.6
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 Month 36: Markedly Worsened	0 percentage of participants Interval 0.0 to 17.6
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 Month 42: Markedly Improved	0 percentage of participants Interval 0.0 to 19.5
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 Month 42: Moderately Improved	0 percentage of participants Interval 0.0 to 19.5
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 Month 42: Mildly Improved	0 percentage of participants Interval 0.0 to 19.5
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 Month 42: Unchanged	29.4 percentage of participants Interval 10.3 to 56.0
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 Month 42: Mildly Worsened	35.3 percentage of participants Interval 14.2 to 61.7
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 Month 42: Moderately Worsened	11.8 percentage of participants Interval 1.5 to 36.4
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 Month 42: Markedly Worsened	23.5 percentage of participants Interval 6.8 to 49.9
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 Month 48: Markedly Improved	0 percentage of participants Interval 0.0 to 24.7
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 Month 48: Moderately Improved	0 percentage of participants Interval 0.0 to 24.7
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 Month 48: Mildly Improved	23.1 percentage of participants Interval 5.0 to 53.8
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 Month 48: Unchanged	53.8 percentage of participants Interval 25.1 to 80.8
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 Month 48: Mildly Worsened	15.4 percentage of participants Interval 1.9 to 45.4
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 Month 48: Moderately Worsened	7.7 percentage of participants Interval 0.2 to 36.0
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 Month 48: Markedly Worsened	0 percentage of participants Interval 0.0 to 24.7
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 Month 54: Markedly Improved	0 percentage of participants Interval 0.0 to 24.7
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 Month 54: Moderately Improved	7.7 percentage of participants Interval 0.2 to 36.0
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 Month 54: Mildly Improved	0 percentage of participants Interval 0.0 to 24.7
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 Month 54: Unchanged	61.5 percentage of participants Interval 31.6 to 86.1
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 Month 54: Mildly Worsened	23.1 percentage of participants Interval 5.0 to 53.8
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 Month 54: Moderately Worsened	7.7 percentage of participants Interval 0.2 to 36.0
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 Month 54: Markedly Worsened	0 percentage of participants Interval 0.0 to 24.7
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 Month 66: Markedly Improved	16.7 percentage of participants Interval 0.4 to 64.1
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 Month 66: Moderately Improved	0 percentage of participants Interval 0.0 to 45.9
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 Month 66: Mildly Improved	0 percentage of participants Interval 0.0 to 45.9
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 Month 66: Unchanged	50.0 percentage of participants Interval 11.8 to 88.2
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 Month 66: Mildly Worsened	0 percentage of participants Interval 0.0 to 45.9
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 Month 66: Moderately Worsened	33.3 percentage of participants Interval 4.3 to 77.7
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 Month 66: Markedly Worsened	0 percentage of participants Interval 0.0 to 45.9
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 Month 72: Markedly Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 72: Moderately Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 72: Mildly Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 72: Unchanged	71.4 percentage of participants Interval 29.0 to 96.3
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 Month 72: Mildly Worsened	28.6 percentage of participants Interval 3.7 to 71.0
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 Month 72: Moderately Worsened	0 percentage of participants Interval 0.0 to 41.0
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 Month 72: Markedly Worsened	0 percentage of participants Interval 0.0 to 41.0
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 Month 78: Markedly Improved	14.3 percentage of participants Interval 0.4 to 57.9
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 Month 78: Moderately Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 78: Mildly Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 78: Unchanged	28.6 percentage of participants Interval 3.7 to 71.0
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 Month 78: Mildly Worsened	28.6 percentage of participants Interval 3.7 to 71.0
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 Month 78: Moderately Worsened	28.6 percentage of participants Interval 3.7 to 71.0
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 Month 78: Markedly Worsened	0 percentage of participants Interval 0.0 to 41.0
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 Month 84: Markedly Improved	16.7 percentage of participants Interval 0.4 to 64.1
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 Month 84: Moderately Improved	0 percentage of participants Interval 0.0 to 45.9
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 Month 84: Mildly Improved	0 percentage of participants Interval 0.0 to 45.9
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 Month 84: Unchanged	33.3 percentage of participants Interval 4.3 to 77.7
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 Month 84: Mildly Worsened	16.7 percentage of participants Interval 0.4 to 64.1
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 Month 84: Moderately Worsened	16.7 percentage of participants Interval 0.4 to 64.1
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 Month 84: Markedly Worsened	16.7 percentage of participants Interval 0.4 to 64.1
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 Month 90: Markedly Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 90: Moderately Improved	0 percentage of participants Interval 0.0 to 41.0
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 Month 90: Mildly Improved	42.9 percentage of participants Interval 9.9 to 81.6
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 Month 90: Unchanged	28.6 percentage of participants Interval 3.7 to 71.0
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 Month 90: Mildly Worsened	28.6 percentage of participants Interval 3.7 to 71.0
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 Month 90: Moderately Worsened	0 percentage of participants Interval 0.0 to 41.0
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 Month 90: Markedly Worsened	0 percentage of participants Interval 0.0 to 41.0
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 Month 96: Markedly Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 96: Moderately Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 96: Mildly Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 96: Unchanged	25.0 percentage of participants Interval 0.6 to 80.6
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 Month 96: Mildly Worsened	50.0 percentage of participants Interval 6.8 to 93.2
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 Month 96: Moderately Worsened	25.0 percentage of participants Interval 0.6 to 80.6
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 Month 96: Markedly Worsened	0 percentage of participants Interval 0.0 to 60.2
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 Month 102: Markedly Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 102: Moderately Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 102: Mildly Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 102: Unchanged	75.0 percentage of participants Interval 19.4 to 99.4
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 Month 102: Mildly Worsened	0 percentage of participants Interval 0.0 to 60.2
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 Month 102: Moderately Worsened	0 percentage of participants Interval 0.0 to 60.2
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 Month 102: Markedly Worsened	25.0 percentage of participants Interval 0.6 to 80.6
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 Month 108: Markedly Improved	40.0 percentage of participants Interval 5.3 to 85.3
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 Month 108: Moderately Improved	0 percentage of participants Interval 0.0 to 52.2
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 Month 108: Mildly Improved	20.0 percentage of participants Interval 0.5 to 71.6
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 Month 108: Unchanged	40.0 percentage of participants Interval 5.3 to 85.3
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 Month 108: Mildly Worsened	0 percentage of participants Interval 0.0 to 52.2
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 Month 108: Moderately Worsened	0 percentage of participants Interval 0.0 to 52.2
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 Month 108: Markedly Worsened	0 percentage of participants Interval 0.0 to 52.2
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 Month 114: Markedly Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 114: Moderately Improved	0 percentage of participants Interval 0.0 to 60.2
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 Month 114: Mildly Improved	25.0 percentage of participants Interval 0.6 to 80.6
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 Month 114: Unchanged	0 percentage of participants Interval 0.0 to 60.2
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 Month 114: Mildly Worsened	75.0 percentage of participants Interval 19.4 to 99.4
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 Month 114: Moderately Worsened	0 percentage of participants Interval 0.0 to 60.2
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 Month 114: Markedly Worsened	0 percentage of participants Interval 0.0 to 60.2
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 Month 120: Markedly Improved	0 percentage of participants Interval 0.0 to 84.2
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 Month 120: Moderately Improved	0 percentage of participants Interval 0.0 to 84.2
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 Month 120: Mildly Improved	50.0 percentage of participants Interval 1.3 to 98.7
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 Month 120: Unchanged	50.0 percentage of participants Interval 1.3 to 98.7
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 Month 120: Mildly Worsened	0 percentage of participants Interval 0.0 to 84.2
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 Month 120: Moderately Worsened	0 percentage of participants Interval 0.0 to 84.2
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 Month 120: Markedly Worsened	0 percentage of participants Interval 0.0 to 84.2
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 Month 126: Markedly Improved	0 percentage of participants Interval 0.0 to 84.2
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 Month 126: Moderately Improved	0 percentage of participants Interval 0.0 to 84.2
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 Month 126: Mildly Improved	0 percentage of participants Interval 0.0 to 84.2
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 Month 126: Unchanged	0 percentage of participants Interval 0.0 to 84.2
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 Month 126: Mildly Worsened	100.0 percentage of participants Interval 15.8 to 100.0
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 Month 126: Moderately Worsened	0 percentage of participants Interval 0.0 to 84.2
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 Month 126: Markedly Worsened	0 percentage of participants Interval 0.0 to 84.2
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 Month 132: Markedly Improved	0 percentage of participants Interval 0.0 to 97.5
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 Month 132: Moderately Improved	0 percentage of participants Interval 0.0 to 97.5
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 Month 132: Mildly Improved	0 percentage of participants Interval 0.0 to 97.5
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 Month 132: Unchanged	0 percentage of participants Interval 0.0 to 97.5
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 Month 132: Mildly Worsened	100.0 percentage of participants Interval 2.5 to 100.0
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 Month 132: Moderately Worsened	0 percentage of participants Interval 0.0 to 97.5
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 Month 132: Markedly Worsened	0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
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 Month 6: Worsened	5 Participants
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 Month 6: Unchanged	25 Participants
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 Month 6: Improved	1 Participants
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 Month 18: Worsened	7 Participants
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 Month 18: Unchanged	17 Participants
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 Month 18: Improved	3 Participants
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 Month 24: Worsened	7 Participants
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 Month 24: Unchanged	12 Participants
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 Month 24: Improved	3 Participants
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 Month 30: Worsened	4 Participants
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 Month 30: Unchanged	14 Participants
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 Month 30: Improved	2 Participants
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 Month 36: Worsened	6 Participants
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 Month 36: Unchanged	11 Participants
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 Month 36: Improved	2 Participants
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 Month 42: Worsened	10 Participants
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 Month 42: Unchanged	5 Participants
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 Month 42: Improved	2 Participants
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 Month 48: Worsened	6 Participants
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 Month 48: Unchanged	4 Participants
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 Month 48: Improved	2 Participants
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 Month 54: Worsened	6 Participants
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 Month 54: Unchanged	6 Participants
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 Month 54: Improved	0 Participants
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 Month 66: Worsened	5 Participants
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 Month 66: Unchanged	1 Participants
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 Month 66: Improved	0 Participants
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 Month 72: Worsened	2 Participants
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 Month 72: Unchanged	5 Participants
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 Month 72: Improved	0 Participants
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 Month 78: Worsened	3 Participants
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 Month 78: Unchanged	4 Participants
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 Month 78: Improved	0 Participants
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 Month 84: Worsened	3 Participants
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 Month 84: Unchanged	3 Participants
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 Month 84: Improved	0 Participants
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 Month 90: Worsened	3 Participants
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 Month 90: Unchanged	4 Participants
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 Month 90: Improved	0 Participants
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 Month 96: Worsened	3 Participants
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 Month 96: Unchanged	1 Participants
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 Month 96: Improved	1 Participants
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 Month 102: Worsened	2 Participants
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 Month 102: Unchanged	2 Participants
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 Month 102: Improved	1 Participants
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 Month 108: Worsened	2 Participants
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 Month 108: Unchanged	1 Participants
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 Month 108: Improved	2 Participants
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 Month 114: Worsened	2 Participants
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 Month 114: Unchanged	2 Participants
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 Month 114: Improved	0 Participants
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 Month 120: Worsened	3 Participants
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 Month 120: Unchanged	1 Participants
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 Month 120: Improved	0 Participants
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 Month 126: Worsened	1 Participants
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 Month 126: Unchanged	1 Participants
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 Month 126: Improved	0 Participants
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 Month 132: Worsened	1 Participants
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 Month 132: Unchanged	0 Participants
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 Month 132: Improved	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
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 Change at Month 6	2.9 meters Standard Deviation 60.64
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 Change at Month 18	-21.6 meters Standard Deviation 108.19
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 Change at Month 24	-15.7 meters Standard Deviation 78.39
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 Change at Month 30	-44.5 meters Standard Deviation 111.67
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 Change at Month 36	-63.5 meters Standard Deviation 101.37
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 Change at Month 42	-95.2 meters Standard Deviation 124.79
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 Change at Month 48	-110.9 meters Standard Deviation 128.57
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 Change at Month 54	-127.8 meters Standard Deviation 124.01
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 Change at Month 66	-63.2 meters Standard Deviation 114.20
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 Change at Month 72	-139.5 meters Standard Deviation 210.18
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 Change at Month 78	-94.3 meters Standard Deviation 177.01
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 Change at Month 84	-100.3 meters Standard Deviation 151.71
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 Change at Month 90	-97.6 meters Standard Deviation 125.50
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 Change at Month 96	-118.9 meters Standard Deviation 114.20
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 Change at Month 102	-82.3 meters Standard Deviation 19.30
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 Change at Month 108	-141.9 meters Standard Deviation 112.29
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 Change at Month 114	-166.9 meters Standard Deviation 137.23
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 Change at Month 120	-184.5 meters Standard Deviation 82.22
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 Change at Month 132	-289.6 meters

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=30 Participants 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.
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 Baseline: Level 1	8 Participants
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 Baseline: Level 2	10 Participants
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 Baseline: Level 3	7 Participants
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 Baseline: Level 4	5 Participants
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 Month 6: Level 1	7 Participants
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 Month 6: Level 2	9 Participants
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 Month 6: Level 3	9 Participants
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 Month 6: Level 4	5 Participants
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 Month 18:Level 1	5 Participants
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 Month 18: Level 2	5 Participants
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 Month 18: Level 3	8 Participants
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 Month 18: Level 4	3 Participants
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 Month 24: Level 1	3 Participants
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 Month 24: Level 2	7 Participants
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 Month 24: Level 3	4 Participants
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 Month 24: Level 4	6 Participants
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 Month 30: Level 1	5 Participants
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 Month 30: Level 2	6 Participants
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 Month 30: Level 3	6 Participants
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 Month 30: Level 4	1 Participants
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 Month 36: Level 1	5 Participants
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 Month 36: Level 2	4 Participants
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 Month 36: Level 3	6 Participants
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 Month 36: Level 4	2 Participants
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 Month 42: Level 1	9 Participants
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 Month 42: Level 2	2 Participants
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 Month 42: Level 3	4 Participants
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 Month 42: Level 4	1 Participants
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 Month 48: Level 1	5 Participants
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 Month 48: Level 2	1 Participants
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 Month 48: Level 3	5 Participants
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 Month 48: Level 4	0 Participants
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 Month 54: Level 1	7 Participants
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 Month 54: Level 2	2 Participants
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 Month 54: Level 3	1 Participants
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 Month 54: Level 4	1 Participants
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 Month 66: Level 1	2 Participants
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 Month 66: Level 2	1 Participants
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 Month 66: Level 3	1 Participants
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 Month 66: Level 4	0 Participants
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 Month 72: Level 1	2 Participants
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 Month 72: Level 2	0 Participants
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 Month 72: Level 3	1 Participants
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 Month 72: Level 4	0 Participants
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 Month 78: Level 1	2 Participants
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 Month 78: Level 2	0 Participants
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 Month 78: Level 3	1 Participants
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 Month 78: Level 4	0 Participants
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 Month 84: Level 1	2 Participants
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 Month 84: Level 2	2 Participants
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 Month 84: Level 3	0 Participants
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 Month 84: Level 4	0 Participants
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 Month 90: Level 1	3 Participants
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 Month 90: Level 2	1 Participants
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 Month 90: Level 3	2 Participants
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 Month 90: Level 4	0 Participants
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 Month 96: Level 1	3 Participants
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 Month 96: Level 2	1 Participants
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 Month 96: Level 3	0 Participants
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 Month 96: Level 4	0 Participants
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 Month 102: Level 1	0 Participants
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 Month 102: Level 2	2 Participants
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 Month 102: Level 3	1 Participants
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 Month 102: Level 4	0 Participants
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 Month 108: Level 1	3 Participants
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 Month 108: Level 2	2 Participants
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 Month 108: Level 3	0 Participants
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 Month 108: Level 4	0 Participants
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 Month 114: Level 1	3 Participants
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 Month 114: Level 2	1 Participants
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 Month 114: Level 3	0 Participants
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 Month 114: Level 4	0 Participants
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 Month 120: Level 1	1 Participants
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 Month 120: Level 2	2 Participants
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 Month 120: Level 3	0 Participants
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 Month 120: Level 4	0 Participants
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 Month 132: Level 1	1 Participants
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 Month 132: Level 2	0 Participants
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 Month 132: Level 3	0 Participants
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 Month 132: Level 4	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=28 Participants 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.
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 Dyspnea: Change at Month 6, Pre walk	0.3 units on a scale Standard Deviation 1.32
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 Dyspnea: Change at Month 6, Post walk	0.9 units on a scale Standard Deviation 1.54
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 Dyspnea: Change at Month 6,Within Visit Difference	0.6 units on a scale Standard Deviation 1.56
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 Dyspnea: Change at Month 18, Pre walk	0.3 units on a scale Standard Deviation 1.11
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 Dyspnea: Change at Month 18, Post walk	0.8 units on a scale Standard Deviation 1.40
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 Dyspnea:Change at Month 18,Within Visit Difference	0.6 units on a scale Standard Deviation 1.93
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 Dyspnea: Change at Month 24, Pre walk	0.3 units on a scale Standard Deviation 0.75
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 Dyspnea: Change at Month 24, Post walk	1.5 units on a scale Standard Deviation 1.91
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 Dyspnea:Change at Month 24,Within Visit Difference	1.1 units on a scale Standard Deviation 2.02
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 Dyspnea: Change at Month 30, Pre walk	0.2 units on a scale Standard Deviation 0.47
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 Dyspnea: Change at Month 30, Post walk	1.2 units on a scale Standard Deviation 1.27
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 Dyspnea:Change at Month 30,Within Visit Difference	1.0 units on a scale Standard Deviation 1.36
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 Dyspnea: Change at Month 36, Pre walk	0.1 units on a scale Standard Deviation 1.36
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 Dyspnea: Change at Month 36, Post walk	-0.2 units on a scale Standard Deviation 2.68
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 Dyspnea:Change at Month 36,Within Visit Difference	-0.3 units on a scale Standard Deviation 1.97
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 Dyspnea: Change at Month 42, Pre walk	0.5 units on a scale Standard Deviation 0.90
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 Dyspnea: Change at Month 42, Post walk	1.0 units on a scale Standard Deviation 1.45
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 Dyspnea:Change at Month 42,Within Visit Difference	0.5 units on a scale Standard Deviation 1.53
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 Dyspnea: Change at Month 48, Pre walk	0.6 units on a scale Standard Deviation 1.17
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 Dyspnea: Change at Month 48, Post walk	1.3 units on a scale Standard Deviation 0.98
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 Dyspnea:Change at Month 48,Within Visit Difference	0.8 units on a scale Standard Deviation 1.64
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 Dyspnea: Change at Month 54, Pre walk	0.4 units on a scale Standard Deviation 1.56
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 Dyspnea: Change at Month 54, Post walk	1.0 units on a scale Standard Deviation 1.93
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 Dyspnea:Change at Month 54,Within Visit Difference	0.6 units on a scale Standard Deviation 1.91
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 Dyspnea: Change at Month 66, Pre walk	1.4 units on a scale Standard Deviation 1.11
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 Dyspnea: Change at Month 66, Post walk	1.5 units on a scale Standard Deviation 1.29
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 Dyspnea:Change at Month 66,Within Visit Difference	0.1 units on a scale Standard Deviation 1.18
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 Dyspnea: Change at Month 72, Pre walk	0.8 units on a scale Standard Deviation 1.44
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 Dyspnea: Change at Month 72, Post walk	0.7 units on a scale Standard Deviation 1.15
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 Dyspnea:Change at Month 72,Within Visit Difference	-0.2 units on a scale Standard Deviation 0.29
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 Dyspnea: Change at Month 78, Pre walk	2.2 units on a scale Standard Deviation 2.02
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 Dyspnea: Change at Month 78, Post walk	0.7 units on a scale Standard Deviation 0.58
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 Dyspnea:Change at Month 78,Within Visit Difference	-1.5 units on a scale Standard Deviation 1.50
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 Dyspnea: Change at Month 84, Pre walk	-0.1 units on a scale Standard Deviation 0.85
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 Dyspnea: Change at Month 84, Post walk	0.5 units on a scale Standard Deviation 1.00
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 Dyspnea:Change at Month 84,Within Visit Difference	0.6 units on a scale Standard Deviation 1.70
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 Dyspnea: Change at Month 90, Pre walk	0.6 units on a scale Standard Deviation 0.66
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 Dyspnea: Change at Month 90, Post walk	-0.8 units on a scale Standard Deviation 2.32
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 Dyspnea:Change at Month 90,Within Visit Difference	-1.4 units on a scale Standard Deviation 2.20
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 Dyspnea: Change at Month 96, Pre walk	1.0 units on a scale Standard Deviation 1.41
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 Dyspnea: Change at Month 96, Post walk	1.3 units on a scale Standard Deviation 1.50
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 Dyspnea:Change at Month 96,Within Visit Difference	0.3 units on a scale Standard Deviation 2.36
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 Dyspnea: Change at Month 102, Pre walk	-0.3 units on a scale Standard Deviation 0.58
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 Dyspnea: Change at Month 102, Post walk	-1.3 units on a scale Standard Deviation 4.04
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 Dyspnea:Change at Month102,Within Visit Difference	-1.0 units on a scale Standard Deviation 3.46
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 Dyspnea: Change at Month 108, Pre walk	1.7 units on a scale Standard Deviation 2.82
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 Dyspnea: Change at Month 108, Post walk	0.7 units on a scale Standard Deviation 4.97
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 Dyspnea:Change at Month108,Within Visit Difference	-1.0 units on a scale Standard Deviation 2.81
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 Dyspnea: Change at Month 114, Pre walk	0.4 units on a scale Standard Deviation 1.80
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 Dyspnea: Change at Month 114, Post walk	0.1 units on a scale Standard Deviation 0.63
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 Dyspnea:Change at Month114,Within Visit Difference	-0.3 units on a scale Standard Deviation 1.19
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 Dyspnea: Change at Month 120, Pre walk	0.3 units on a scale Standard Deviation 1.53
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 Dyspnea: Change at Month 120, Post walk	-0.8 units on a scale Standard Deviation 1.04
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 Dyspnea:Change at Month120,Within Visit Difference	-1.2 units on a scale Standard Deviation 2.47
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 Dyspnea: Change at Month 132, Pre walk	-1.0 units on a scale
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 Dyspnea: Change at Month 132, Post walk	-1.0 units on a scale
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 Dyspnea:Change at Month132,Within Visit Difference	0.0 units on a scale
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 Fatigue: Change at Month 6, Pre walk	0.2 units on a scale Standard Deviation 1.69
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 Fatigue: Change at Month 6, Post walk	0.7 units on a scale Standard Deviation 2.82
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 Fatigue:Change at Month 6,Within Visit Difference	0.4 units on a scale Standard Deviation 2.92
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 Fatigue: Change at Month 18, Pre walk	0.0 units on a scale Standard Deviation 2.13
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 Fatigue: Change at Month 18, Post walk	0.2 units on a scale Standard Deviation 1.40
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 Fatigue:Change at Month 18,Within Visit Difference	0.2 units on a scale Standard Deviation 2.51
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 Fatigue: Change at Month 24, Pre walk	0.1 units on a scale Standard Deviation 1.66
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 Fatigue: Change at Month 24, Post walk	1.0 units on a scale Standard Deviation 2.33
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 Fatigue:Change at Month 24,Within Visit Difference	0.9 units on a scale Standard Deviation 2.97
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 Fatigue: Change at Month 30, Pre walk	-0.4 units on a scale Standard Deviation 1.58
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 Fatigue: Change at Month 30, Post walk	0.9 units on a scale Standard Deviation 1.65
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 Fatigue:Change at Month 30,Within Visit Difference	1.3 units on a scale Standard Deviation 2.23
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 Fatigue: Change at Month 36, Pre walk	-0.2 units on a scale Standard Deviation 2.29
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 Fatigue: Change at Month 36, Post walk	0.8 units on a scale Standard Deviation 2.05
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 Fatigue:Change at Month 36,Within Visit Difference	1.0 units on a scale Standard Deviation 2.76
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 Fatigue: Change at Month 42, Pre walk	0.4 units on a scale Standard Deviation 1.76
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 Fatigue: Change at Month 42, Post walk	1.6 units on a scale Standard Deviation 1.86
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 Fatigue:Change at Month 42,Within Visit Difference	1.2 units on a scale Standard Deviation 2.86
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 Fatigue: Change at Month 48, Pre walk	0.6 units on a scale Standard Deviation 1.26
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 Fatigue: Change at Month 48, Post walk	1.5 units on a scale Standard Deviation 1.84
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 Fatigue:Change at Month 48,Within Visit Difference	0.9 units on a scale Standard Deviation 2.38
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 Fatigue: Change at Month 54, Pre walk	0.5 units on a scale Standard Deviation 1.57
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 Fatigue: Change at Month 54, Post walk	0.5 units on a scale Standard Deviation 1.90
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 Fatigue:Change at Month 54,Within Visit Difference	-0.1 units on a scale Standard Deviation 1.97
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 Fatigue: Change at Month 66, Pre walk	0.3 units on a scale Standard Deviation 0.50
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 Fatigue: Change at Month 66, Post walk	0.5 units on a scale Standard Deviation 2.38
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 Fatigue:Change at Month 66,Within Visit Difference	0.3 units on a scale Standard Deviation 2.22
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 Fatigue: Change at Month 72, Pre walk	2.0 units on a scale Standard Deviation 1.73
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 Fatigue: Change at Month 72, Post walk	1.0 units on a scale Standard Deviation 1.73
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 Fatigue:Change at Month 72,Within Visit Difference	-1.0 units on a scale Standard Deviation 0.00
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 Fatigue: Change at Month 78, Pre walk	2.0 units on a scale Standard Deviation 2.00
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 Fatigue: Change at Month 78, Post walk	1.0 units on a scale Standard Deviation 2.65
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 Fatigue:Change at Month 78,Within Visit Difference	-1.0 units on a scale Standard Deviation 1.00
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 Fatigue: Change at Month 84, Pre walk	0.0 units on a scale Standard Deviation 0.82
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 Fatigue: Change at Month 84, Post walk	0.4 units on a scale Standard Deviation 1.11
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 Fatigue:Change at Month 84,Within Visit Difference	0.4 units on a scale Standard Deviation 1.49
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 Fatigue: Change at Month 90, Pre walk	1.3 units on a scale Standard Deviation 1.75
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 Fatigue: Change at Month 90, Post walk	-0.3 units on a scale Standard Deviation 2.07
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 Fatigue:Change at Month 90,Within Visit Difference	-1.7 units on a scale Standard Deviation 3.27
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 Fatigue: Change at Month 96, Pre walk	0.8 units on a scale Standard Deviation 1.50
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 Fatigue: Change at Month 96, Post walk	0.0 units on a scale Standard Deviation 0.82
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 Fatigue:Change at Month 96,Within Visit Difference	-0.8 units on a scale Standard Deviation 1.71
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 Fatigue: Change at Month 102, Pre walk	1.0 units on a scale Standard Deviation 2.65
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 Fatigue: Change at Month 102, Post walk	-0.7 units on a scale Standard Deviation 1.53
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 Fatigue:Change at Month102,Within Visit Difference	-1.7 units on a scale Standard Deviation 1.15
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 Fatigue: Change at Month 108, Pre walk	1.8 units on a scale Standard Deviation 2.77
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 Fatigue: Change at Month 108, Post walk	0.9 units on a scale Standard Deviation 3.54
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 Fatigue:Change at Month108,Within Visit Difference	-0.9 units on a scale Standard Deviation 1.14
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 Fatigue: Change at Month 114, Pre walk	1.0 units on a scale Standard Deviation 2.16
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 Fatigue: Change at Month 114, Post walk	-0.1 units on a scale Standard Deviation 0.85
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 Fatigue:Change at Month114,Within Visit Difference	-1.1 units on a scale Standard Deviation 1.44
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 Fatigue: Change at Month 120, Pre walk	0.0 units on a scale Standard Deviation 1.00
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 Fatigue: Change at Month 120, Post walk	-1.2 units on a scale Standard Deviation 0.76
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 Fatigue:Change at Month120,Within Visit Difference	-1.2 units on a scale Standard Deviation 1.76
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 Fatigue: Change at Month 132, Pre walk	-1.0 units on a scale
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 Fatigue: Change at Month 132, Post walk	-0.5 units on a scale
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 Fatigue:Change at Month132,Within Visit Difference	0.5 units on a scale

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132

Population: 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.

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'.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=30 Participants 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.
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 Month 6: Worsened	5 Participants
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 Month 6: Unchanged	20 Participants
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 Month 6: Improved	5 Participants
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 Month 18: Worsened	9 Participants
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 Month 18: Unchanged	7 Participants
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 Month 18: Improved	5 Participants
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 Month 24: Worsened	6 Participants
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 Month 24: Unchanged	10 Participants
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 Month 24: Improved	4 Participants
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 Month 30: Worsened	9 Participants
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 Month 30: Unchanged	4 Participants
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 Month 30: Improved	5 Participants
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 Month 36: Worsened	8 Participants
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 Month 36: Unchanged	7 Participants
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 Month 36: Improved	2 Participants
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 Month 42: Worsened	9 Participants
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 Month 42: Unchanged	6 Participants
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 Month 42: Improved	1 Participants
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 Month 48: Worsened	7 Participants
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 Month 48: Unchanged	3 Participants
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 Month 48: Improved	1 Participants
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 Month 54: Worsened	7 Participants
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 Month 54: Unchanged	4 Participants
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 Month 54: Improved	0 Participants
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 Month 66: Worsened	3 Participants
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 Month 66: Unchanged	1 Participants
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 Month 66: Improved	0 Participants
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 Month 72: Worsened	2 Participants
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 Month 72: Unchanged	1 Participants
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 Month 72: Improved	0 Participants
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 Month 78: Worsened	2 Participants
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 Month 78: Unchanged	1 Participants
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 Month 78: Improved	0 Participants
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 Month 84: Worsened	3 Participants
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 Month 84: Unchanged	1 Participants
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 Month 84: Improved	0 Participants
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 Month 90: Worsened	4 Participants
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 Month 90: Unchanged	1 Participants
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 Month 90: Improved	1 Participants
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 Month 96: Worsened	3 Participants
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 Month 96: Unchanged	1 Participants
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 Month 96: Improved	0 Participants
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 Month 102: Worsened	2 Participants
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 Month 102: Unchanged	1 Participants
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 Month 102: Improved	0 Participants
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 Month 108: Worsened	4 Participants
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 Month 108: Unchanged	1 Participants
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 Month 108: Improved	0 Participants
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 Month 114: Worsened	3 Participants
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 Month 114: Unchanged	1 Participants
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 Month 114: Improved	0 Participants
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 Month 120: Worsened	3 Participants
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 Month 120: Unchanged	0 Participants
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 Month 120: Improved	0 Participants
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 Month 132: Worsened	1 Participants
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 Month 132: Unchanged	0 Participants
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 Month 132: Improved	0 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132

Population: 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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
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 Overall Summary Score: Change at Month 6	-2.12 units on a scale Standard Deviation 12.423
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 Overall Summary Score: Change at Month 18	-4.58 units on a scale Standard Deviation 18.926
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 Overall Summary Score: Change at Month 24	-2.94 units on a scale Standard Deviation 16.247
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 Overall Summary Score: Change at Month 30	-5.41 units on a scale Standard Deviation 17.695
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 Overall Summary Score: Change at Month 36	-6.86 units on a scale Standard Deviation 18.525
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 Overall Summary Score: Change at Month 42	-12.76 units on a scale Standard Deviation 23.646
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 Overall Summary Score: Change at Month 48	-13.22 units on a scale Standard Deviation 24.893
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 Overall Summary Score: Change at Month 54	-14.99 units on a scale Standard Deviation 23.688
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 Overall Summary Score: Change at Month 66	-1.77 units on a scale Standard Deviation 30.476
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 Overall Summary Score: Change at Month 72	0.41 units on a scale Standard Deviation 23.317
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 Overall Summary Score: Change at Month 78	-3.60 units on a scale Standard Deviation 24.231
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 Overall Summary Score: Change at Month 84	-3.72 units on a scale Standard Deviation 32.770
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 Overall Summary Score: Change at Month 90	-0.28 units on a scale Standard Deviation 30.296
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 Overall Summary Score: Change at Month 96	-17.84 units on a scale Standard Deviation 47.842
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 Overall Summary Score: Change at Month 102	-12.63 units on a scale Standard Deviation 40.904
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 Overall Summary Score: Change at Month 108	-1.19 units on a scale Standard Deviation 35.375
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 Overall Summary Score: Change at Month 114	-2.99 units on a scale Standard Deviation 37.897
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 Overall Summary Score: Change at Month 120	-35.55 units on a scale Standard Deviation 9.023
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 Overall Summary Score: Change at Month 126	-39.32 units on a scale Standard Deviation 8.102
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 Overall Summary Score: Change at Month 132	-40.10 units on a scale
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 Clinical Summary Score: Change at Month 6	-3.00 units on a scale Standard Deviation 11.650
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 Clinical Summary Score: Change at Month 18	-6.66 units on a scale Standard Deviation 17.340
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 Clinical Summary Score: Change at Month 24	-2.87 units on a scale Standard Deviation 15.875
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 Clinical Summary Score: Change at Month 30	-7.80 units on a scale Standard Deviation 17.497
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 Clinical Summary Score: Change at Month 36	-9.53 units on a scale Standard Deviation 17.700
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 Clinical Summary Score: Change at Month 42	-17.05 units on a scale Standard Deviation 22.804
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 Clinical Summary Score: Change at Month 48	-15.67 units on a scale Standard Deviation 24.854
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 Clinical Summary Score: Change at Month 54	-16.90 units on a scale Standard Deviation 21.295
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 Clinical Summary Score: Change at Month 66	-3.45 units on a scale Standard Deviation 27.219
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 Clinical Summary Score: Change at Month 72	-1.82 units on a scale Standard Deviation 21.558
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 Clinical Summary Score: Change at Month 78	-7.13 units on a scale Standard Deviation 22.422
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 Clinical Summary Score: Change at Month 84	-6.53 units on a scale Standard Deviation 29.881
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 Clinical Summary Score: Change at Month 90	-2.47 units on a scale Standard Deviation 24.198
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 Clinical Summary Score: Change at Month 96	-19.27 units on a scale Standard Deviation 42.768
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 Clinical Summary Score: Change at Month 102	-15.10 units on a scale Standard Deviation 31.690
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 Clinical Summary Score: Change at Month 108	-3.26 units on a scale Standard Deviation 27.764
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 Clinical Summary Score: Change at Month 114	-4.69 units on a scale Standard Deviation 32.213
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 Clinical Summary Score: Change at Month 120	-42.45 units on a scale Standard Deviation 11.417
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 Clinical Summary Score: Change at Month 126	-38.02 units on a scale Standard Deviation 14.731
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 Clinical Summary Score: Change at Month 132	-40.63 units on a scale

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Abnormalities in Echocardiography	31 Participants

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
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 Troponin I: Change at Month 6	-0.016 nanogram per milliliter Standard Deviation 0.0533
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 Troponin I: Change at Month 18	0.032 nanogram per milliliter Standard Deviation 0.1307
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 Troponin I: Change at Month 24	0.023 nanogram per milliliter Standard Deviation 0.0986
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 Troponin I: Change at Month 30	0.022 nanogram per milliliter Standard Deviation 0.1038
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 Troponin I: Change at Month 36	0.029 nanogram per milliliter Standard Deviation 0.1099
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 Troponin I: Change at Month 42	0.042 nanogram per milliliter Standard Deviation 0.1409
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 Troponin I: Change at Month 48	0.058 nanogram per milliliter Standard Deviation 0.1409
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 Troponin I: Change at Month 54	0.042 nanogram per milliliter Standard Deviation 0.1226
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 Troponin I: Change at Month 66	-0.012 nanogram per milliliter Standard Deviation 0.0133
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 Troponin I: Change at Month 72	-0.010 nanogram per milliliter Standard Deviation 0.0183
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 Troponin I: Change at Month 78	-0.013 nanogram per milliliter Standard Deviation 0.0208
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 Troponin I: Change at Month 84	-0.008 nanogram per milliliter Standard Deviation 0.0096
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 Troponin I: Change at Month 90	-0.003 nanogram per milliliter Standard Deviation 0.0293
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 Troponin I: Change at Month 96	-0.008 nanogram per milliliter Standard Deviation 0.0150
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 Troponin I: Change at Month 102	-0.010 nanogram per milliliter Standard Deviation 0.0356
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 Troponin I: Change at Month 108	0.000 nanogram per milliliter Standard Deviation 0.0071
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 Troponin I: Change at Month 114	0.000 nanogram per milliliter Standard Deviation 0.0271
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 Troponin I: Change at Month 120	0.000 nanogram per milliliter Standard Deviation 0.0141
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 Troponin I: Change at Month 126	0.005 nanogram per milliliter Standard Deviation 0.0354
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 Troponin T: Change at Month 6	-0.0007 nanogram per milliliter Standard Deviation 0.01710
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 Troponin T: Change at Month 18	0.0271 nanogram per milliliter Standard Deviation 0.07429
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 Troponin T: Change at Month 24	0.0132 nanogram per milliliter Standard Deviation 0.03286
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 Troponin T: Change at Month 30	0.0166 nanogram per milliliter Standard Deviation 0.02227
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 Troponin T: Change at Month 36	0.0205 nanogram per milliliter Standard Deviation 0.03049
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 Troponin T: Change at Month 42	0.0329 nanogram per milliliter Standard Deviation 0.05665
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 Troponin T: Change at Month 48	0.0510 nanogram per milliliter Standard Deviation 0.09562
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 Troponin T: Change at Month 54	0.0562 nanogram per milliliter Standard Deviation 0.13264
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 Troponin T: Change at Month 66	0.0050 nanogram per milliliter Standard Deviation 0.02588
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 Troponin T: Change at Month 72	-0.0055 nanogram per milliliter Standard Deviation 0.01714
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 Troponin T: Change at Month 78	0.0000 nanogram per milliliter Standard Deviation 0.01732
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 Troponin T: Change at Month 84	-0.0003 nanogram per milliliter Standard Deviation 0.01415
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 Troponin T: Change at Month 90	0.0026 nanogram per milliliter Standard Deviation 0.00962
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 Troponin T: Change at Month 96	-0.0037 nanogram per milliliter Standard Deviation 0.00551
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 Troponin T: Change at Month 102	0.0098 nanogram per milliliter Standard Deviation 0.01461
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 Troponin T: Change at Month 108	0.0100 nanogram per milliliter Standard Deviation 0.00707
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 Troponin T: Change at Month114	0.0100 nanogram per milliliter Standard Deviation 0.00816
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 Troponin T: Change at Month 120	0.0150 nanogram per milliliter Standard Deviation 0.02121
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 Troponin T: Change at Month 126	0.0000 nanogram per milliliter

SECONDARY outcome

Timeframe: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126

NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
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 Change at Month 6	66.0 nanogram per milliliter Standard Deviation 2164.66
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 Change at Month 18	492.0 nanogram per milliliter Standard Deviation 2455.65
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 Change at Month 24	211.5 nanogram per milliliter Standard Deviation 2119.01
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 Change at Month 30	701.8 nanogram per milliliter Standard Deviation 2423.16
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 Change at Month 36	1063.5 nanogram per milliliter Standard Deviation 2813.85
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 Change at Month 42	2510.2 nanogram per milliliter Standard Deviation 5143.47
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 Change at Month 48	3761.2 nanogram per milliliter Standard Deviation 7892.80
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 Change at Month 54	1668.1 nanogram per milliliter Standard Deviation 2677.27
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 Change at Month 66	433.3 nanogram per milliliter Standard Deviation 493.76
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 Change at Month 72	625.5 nanogram per milliliter Standard Deviation 471.41
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 Change at Month 78	707.7 nanogram per milliliter Standard Deviation 236.53
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 Change at Month 84	348.5 nanogram per milliliter Standard Deviation 700.98
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 Change at Month 90	283.7 nanogram per milliliter Standard Deviation 971.53
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 Change at Month 96	1453.0 nanogram per milliliter Standard Deviation 2193.75
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 Change at Month 108	346.4 nanogram per milliliter Standard Deviation 1279.58
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 Change at Month 114	465.7 nanogram per milliliter Standard Deviation 790.48
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 Change at Month 120	1232.0 nanogram per milliliter Standard Deviation 667.51
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 Change at Month 126	1249.0 nanogram per milliliter
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 Change at Month 102	1439.0 nanogram per milliliter Standard Deviation 2032.43

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events All-cause Hospitalization	27 Participants
Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events Cardiac Related Hospitalization	18 Participants

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Time to All-cause Mortality and Cardiac-Related Mortality All-Cause Mortality	4.1 years Interval 1.9 to 5.4
Time to All-cause Mortality and Cardiac-Related Mortality Cardiac-related mortality	5.9 years Interval 3.0 to Due to very less number of events upper limit of 95% CI could not be estimated, hence not provided.

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with AEs	31 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participants with SAEs	29 Participants

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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).

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participant with AEs	7 Participants
Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Participant with SAEs	4 Participants

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=28 Participants 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.
Number of Participants With Clinically Significant Physical Examination Findings	19 Participants

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

Number of participants who used medication other than study drug were reported.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Any Concomitant Medications	31 Participants

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings	1 Participants

SECONDARY outcome

Timeframe: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303

Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Tafamidis 20 mg n=31 Participants 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.
Number of Participants With Laboratory Abnormalities	27 Participants

Adverse Events

Tafamidis 20 mg

Serious events: 29 serious events

Other events: 30 other events

Deaths: 23 deaths

Serious adverse events

Serious adverse events
Measure	Tafamidis 20 mg n=31 participants at risk 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.
Blood and lymphatic system disorders Anaemia	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Blood and lymphatic system disorders HEPARIN-INDUCED THROMBOCYTOPENIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ARRHYTHMIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIAL FIBRILLATION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIAL FLUTTER	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIAL TACHYCARDIA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIOVENTRICULAR BLOCK	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC AMYLOIDOSIS	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC ARREST	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC FAILURE	19.4% 6/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC FAILURE ACUTE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC FAILURE CHRONIC	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	29.0% 9/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIO-RESPIRATORY ARREST	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIOGENIC SHOCK	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders LEFT VENTRICULAR FAILURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Congenital, familial and genetic disorders FAMILIAL AMYLOIDOSIS	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders FAECALOMA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders OESOPHAGEAL MOTILITY DISORDER	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders PANCREATITIS	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders ASTHENIA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders CHEST DISCOMFORT	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders CHEST PAIN	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders DEATH	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders OEDEMA PERIPHERAL	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations BACTERIAL SEPSIS	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations CELLULITIS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations DEVICE RELATED INFECTION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations INFLUENZA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations KLEBSIELLA BACTERAEMIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations PNEUMONIA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations SEPSIS	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations STAPHYLOCOCCAL INFECTION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations UROSEPSIS	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications CARDIAC CONTUSION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications FALL	19.4% 6/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications FEMUR FRACTURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications PELVIC FRACTURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications RIB FRACTURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications SKIN LACERATION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations WEIGHT INCREASED	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders DEHYDRATION	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders FAILURE TO THRIVE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders GOUT	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders HYPERKALAEMIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC MALIGNANT MELANOMA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders CEREBROVASCULAR ACCIDENT	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders DEMENTIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders EMBOLIC STROKE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders METABOLIC ENCEPHALOPATHY	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders PARKINSONISM	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders PRESYNCOPE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders SYNCOPE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Psychiatric disorders HALLUCINATION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Psychiatric disorders MENTAL STATUS CHANGES	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Renal and urinary disorders ACUTE KIDNEY INJURY	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Renal and urinary disorders END STAGE RENAL DISEASE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Renal and urinary disorders POLYURIA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Renal and urinary disorders RENAL FAILURE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders LARYNGEAL OEDEMA	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders SKIN ULCER	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Vascular disorders VARICOSE VEIN RUPTURED	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Psychiatric disorders CONFUSIONAL STATE	3.2% 1/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.

Other adverse events

Other adverse events
Measure	Tafamidis 20 mg n=31 participants at risk 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.
Blood and lymphatic system disorders ANAEMIA	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIAL FIBRILLATION	16.1% 5/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC FAILURE	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders PALPITATIONS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Congenital, familial and genetic disorders FAMILIAL AMYLOIDOSIS	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Endocrine disorders HYPOTHYROIDISM	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Eye disorders CATARACT	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Cardiac disorders ATRIAL FLUTTER	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders ABDOMINAL DISTENSION	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders ABDOMINAL PAIN	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders CONSTIPATION	35.5% 11/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders DIARRHOEA	16.1% 5/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders LARGE INTESTINE POLYP	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Gastrointestinal disorders NAUSEA	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders ASTHENIA	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders CHEST PAIN	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders GAIT DISTURBANCE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders OEDEMA PERIPHERAL	16.1% 5/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders PERIPHERAL SWELLING	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders PYREXIA	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations BRONCHITIS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations CELLULITIS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations EAR INFECTION	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations NASOPHARYNGITIS	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations PNEUMONIA	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations STAPHYLOCOCCAL INFECTION	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	16.1% 5/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Infections and infestations URINARY TRACT INFECTION	19.4% 6/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications CONTUSION	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications FALL	41.9% 13/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications HUMERUS FRACTURE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications RIB FRACTURE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications SKIN ABRASION	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations BLOOD THYROID STIMULATING HORMONE INCREASED	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations BRAIN NATRIURETIC PEPTIDE INCREASED	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations PROTHROMBIN TIME PROLONGED	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations VENOUS PRESSURE JUGULAR INCREASED	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations WEIGHT DECREASED	19.4% 6/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Investigations WEIGHT INCREASED	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders DECREASED APPETITE	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders DEHYDRATION	22.6% 7/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders FAILURE TO THRIVE	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders FLUID OVERLOAD	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Metabolism and nutrition disorders HYPOKALAEMIA	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders ARTHRALGIA	29.0% 9/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders BACK PAIN	35.5% 11/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders NECK PAIN	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	22.6% 7/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders BALANCE DISORDER	16.1% 5/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders DIZZINESS	16.1% 5/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders DIZZINESS POSTURAL	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders HEADACHE	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders MEMORY IMPAIRMENT	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders SYNCOPE	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Nervous system disorders TREMOR	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Psychiatric disorders DEPRESSION	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Psychiatric disorders MENTAL STATUS CHANGES	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders COUGH	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	29.0% 9/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Respiratory, thoracic and mediastinal disorders WHEEZING	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders ECCHYMOSIS	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders PRURITUS	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders RASH	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders SKIN ULCER	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Skin and subcutaneous tissue disorders URTICARIA	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Vascular disorders HYPOTENSION	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Vascular disorders ORTHOSTATIC HYPOTENSION	6.5% 2/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
General disorders FATIGUE	32.3% 10/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Injury, poisoning and procedural complications SKIN LACERATION	22.6% 7/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Psychiatric disorders INSOMNIA	9.7% 3/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.
Renal and urinary disorders HAEMATURIA	12.9% 4/31 • Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 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.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER