Transthyretin (TTR) Amyloid Cardiomyopathy
Conditions
Keywords
amyloidosis, amyloid, transthyretin, TTR, ATTR-CM
Brief summary
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy
Detailed description
Global Phase 3, open label long term extension safety study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR CM via prescription, whichever occurs first.
Interventions
DRUGTafamidis
Soft gel capsules administered once a day for 60 months
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Cohort A: Completion of 30 months of study treatment on Pfizer Protocol B3461028 Cohort B: Patients in specific countries diagnosed with ATTR-CM who did not previously participate in Pfizer Study B3461028
Exclusion criteria
-Liver and/or heart transplant, or implanted cardiac mechanical assist device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to All-Cause Mortality: Cohort A | From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months] | Time to all-cause mortality was calculated from first dose of randomized treatment in parent study (B3461028) to all-cause mortality events. All-cause mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to Adverse event (AE), or alive at the time of analysis. Kaplan Meier method was used for analysis. Therefore, this analysis was based on the pooled dose groups, as per the statistical analysis plan (SAP). |
| Number of Participants With All-Cause Mortality Events: Cohort B | B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) | All-cause mortality included all participants who had discontinue for transplantation (i.e. heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to AE), or alive at the time of analysis. Kaplan Meier method was used for analysis. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) | An AE was any untoward medical occurrence in a participant who received investigational product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. 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 SAEs and all Non-SAEs. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; considered an important medical event. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Annualized Rate of Cardiovascular (CV)-Related Hospitalizations | B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) | Mean annual rate of CV related hospitalization was calculated for each participant as the participant's number of CV related hospitalizations divided by this participant's duration on study in years. CV-related hospitalizations included hospitalizations due to heart failure, arrhythmia, myocardial infarction, stroke, and other cardiovascular-related events. Hospitalization was defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility or any prolongation of an existing admission. Admission also included transfer within the hospital to an acute/intensive care unit (example: from the psychiatric wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a tuberculosis unit). |
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045) | KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-clinical summary score was calculated as mean of the following domains- physical limitation and total symptoms and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as least square (LS) mean. |
| Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045) | KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-overall score was calculated as mean of the following domains- physical limitation, total symptoms (average of symptom frequency & symptom burden), quality of life, social limitation and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as LS mean. |
| Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Troponin I is the cardiac markers. Higher level of the marker was indicative of heart damage. It was measure in nanogram per milliliter (ng/mL). Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. |
| Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045) | KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ Total Symptoms score was calculated as mean of the following domains- symptom frequency and symptom burden and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as LS mean. |
| Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B | B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54 | KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-clinical summary score was calculated as mean of the following domains- physical limitation and total symptoms and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean. |
| Time to Cardiovascular-Related Mortality Events: Cohort A | From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months] | Time to cardiovascular-related mortality was calculated from first dose of randomized treatment in B3461028 . Participants who discontinued for transplantation (that is heart transplantation and combined heart and liver transplantation) or for implantation of cardiac mechanical assist device were treated as a death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Kaplan-Meier method was used. Therefore, this analysis was based on the pooled dose groups, as per the SAP. |
| Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B | B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54 | KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ Total Symptoms score was calculated as mean of the following domains- symptom frequency and symptom burden and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean. |
| Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | NYHA classification: Class I: Participants with cardiovascular disease (CVD) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; Class II: Participants with CVD resulting in slight limitation of physical activity and were comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina pain; Class III: participants with CVD resulting in marked limitation of physical activity and were comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain; Class IV: participants with CVD resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity was undertaken, discomfort was increased. |
| Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | BMI was calculated as: body weight in kilogram (kg) divided by (/) square of body height measurement in meters square (m\^2). |
| Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Modified (m)BMI of participants was calculated to determine if there was any gastrointestinal involvement in participants. The mBMI was calculated by multiplying BMI by serum albumin concentration gram/liter (g/L). |
| Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. It was measure in picomole per liter (pmole/L). Higher level of the marker was indicative of heart damage. Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. |
| Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B | B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54 | KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-overall score was calculated as mean of the following domains- physical limitation, total symptoms (average of symptom frequency & symptom burden), quality of life, social limitation and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean. |
| Number of Participants With Cardiovascular Related Mortality Events: Cohort B | B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) | Deaths adjudicated as cardiovascular-related and indeterminate were reported. Cardiovascular-related mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Cardiovascular relatedness was based on clinical judgement. |
| Mean Annualized Rate of All Cause Hospitalizations | B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months) | Mean annual rate of all cause hospitalization was calculated for each participant as the participant's number of all cause hospitalizations divided by this participant's duration on study in years. Hospitalization was defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility or any prolongation of an existing admission. Only all cause hospitalizations where the participant was admitted to a hospital during the current extension study were included in this analysis. Any hospitalizations prior to randomization date were not included. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
The study consisted of two cohorts: Cohort A and B. Cohort A: Participants diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) who completed 30 months of participation in parent study \[B3461028 (NCT01994889)\] were enrolled in this current extension study (B3461045 \[NCT02791230\]). Cohort B: Participants diagnosed with ATTR-CM who did not participate in parent study B3461028 study were enrolled in this extension study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Tafamidis (Parent and Extension Study) Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months. | 170 |
| Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study) Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months. | 82 |
| Cohort B: Tafamidis (Only in Extension Study) Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months. | 1,476 |
| Total | 1,728 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 9 | 66 |
| Overall Study | Death | 38 | 25 | 184 |
| Overall Study | Enrolled but not treated | 0 | 0 | 5 |
| Overall Study | Failure to Meet Randomization Criteria | 3 | 2 | 15 |
| Overall Study | Lack of Efficacy | 1 | 0 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 10 |
| Overall Study | Medication Error Without Associated Adverse Event | 0 | 1 | 1 |
| Overall Study | Other | 9 | 1 | 28 |
| Overall Study | Protocol Violation | 0 | 0 | 4 |
| Overall Study | Study sites terminated by sponsor | 1 | 0 | 5 |
| Overall Study | Withdrawal by Subject | 24 | 13 | 172 |
Baseline characteristics
| Characteristic | Cohort A: Tafamidis (Parent and Extension Study) | Total | Cohort B: Tafamidis (Only in Extension Study) | Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study) |
|---|---|---|---|---|
| Age, Continuous | 76.73 Years STANDARD_DEVIATION 6.75 | 76.52 Years STANDARD_DEVIATION 7.6 | 76.51 Years STANDARD_DEVIATION 7.75 | 76.41 Years STANDARD_DEVIATION 6.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 43 Participants | 37 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 164 Participants | 1678 Participants | 1433 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 7 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 80 Participants | 66 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 159 Participants | 139 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 21 Participants | 19 Participants | 0 Participants |
| Race (NIH/OMB) White | 144 Participants | 1468 Participants | 1252 Participants | 72 Participants |
| Sex: Female, Male Female | 13 Participants | 186 Participants | 165 Participants | 8 Participants |
| Sex: Female, Male Male | 157 Participants | 1542 Participants | 1311 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 45 / 170 | 33 / 82 | 203 / 1,476 |
| other Total, other adverse events | 152 / 170 | 76 / 82 | 1,023 / 1,476 |
| serious Total, serious adverse events | 132 / 170 | 64 / 82 | 736 / 1,476 |
Outcome results
Primary
Number of Participants With All-Cause Mortality Events: Cohort B
All-cause mortality included all participants who had discontinue for transplantation (i.e. heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to AE), or alive at the time of analysis. Kaplan Meier method was used for analysis.
Time frame: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Population: Safety analysis population consisted of all participants (Cohort B) who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With All-Cause Mortality Events: Cohort B | 345 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received investigational product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. 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 SAEs and all Non-SAEs. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; considered an important medical event.
Time frame: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Population: Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 168 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 79 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Treatment-Emergent Adverse Events (AEs) | 1294 Participants |
Primary
Time to All-Cause Mortality: Cohort A
Time to all-cause mortality was calculated from first dose of randomized treatment in parent study (B3461028) to all-cause mortality events. All-cause mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to Adverse event (AE), or alive at the time of analysis. Kaplan Meier method was used for analysis. Therefore, this analysis was based on the pooled dose groups, as per the statistical analysis plan (SAP).
Time frame: From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months]
Population: Combined mortality analysis (CMA) set included all participants in the Intent-To-Treat (ITT)-analysis set from study B3461028 (NCT01994889). Mortality analyses in study B3461045 for Cohort A participants included combined data from participants in study B3461028 (NCT01994889), including participants who died, discontinued in B3461028, or were not enrolled into B3461045 (i.e. ITT Analysis Set from B3461028 \[NCT01994889\]) with mortality data through participation in the B3461045 study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Time to All-Cause Mortality: Cohort A | 58.7 Months |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Time to All-Cause Mortality: Cohort A | 35.8 Months |
p-value: 0.000195% CI: [0.4865, 0.7906]Cox proportional hazards model
Other Pre-specified
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
BMI was calculated as: body weight in kilogram (kg) divided by (/) square of body height measurement in meters square (m\^2).
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | -0.07 kg/m^2 | Standard Deviation 0.873 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -1.14 kg/m^2 | Standard Deviation 1.48 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -0.71 kg/m^2 | Standard Deviation 1.423 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | -0.93 kg/m^2 | Standard Deviation 2.102 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -0.91 kg/m^2 | Standard Deviation 1.402 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -1.18 kg/m^2 | Standard Deviation 2.2 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -0.38 kg/m^2 | Standard Deviation 1.442 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | -0.21 kg/m^2 | Standard Deviation 1.212 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -1.03 kg/m^2 | Standard Deviation 1.716 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -0.36 kg/m^2 | Standard Deviation 1.407 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | -1.62 kg/m^2 | Standard Deviation 0.834 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | -0.27 kg/m^2 | Standard Deviation 0.9 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | -0.40 kg/m^2 | Standard Deviation 1.44 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -0.85 kg/m^2 | Standard Deviation 1.502 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -0.78 kg/m^2 | Standard Deviation 1.668 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -1.28 kg/m^2 | Standard Deviation 1.814 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -0.49 kg/m^2 | Standard Deviation 1.852 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -0.11 kg/m^2 | Standard Deviation 1.523 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -0.01 kg/m^2 | Standard Deviation 1.927 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -1.54 kg/m^2 | Standard Deviation 0.528 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -0.74 kg/m^2 | Standard Deviation 1.827 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -0.43 kg/m^2 | Standard Deviation 1.747 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | -0.20 kg/m^2 | Standard Deviation 1.552 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -0.83 kg/m^2 | Standard Deviation 1.732 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -0.30 kg/m^2 | Standard Deviation 1.956 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | -0.24 kg/m^2 | Standard Deviation 1.234 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -0.69 kg/m^2 | Standard Deviation 1.73 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -0.41 kg/m^2 | Standard Deviation 1.802 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -1.24 kg/m^2 | Standard Deviation 1.942 |
Other Pre-specified
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-clinical summary score was calculated as mean of the following domains- physical limitation and total symptoms and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as least square (LS) mean.
Time frame: B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045)
Population: CMA set was analyzed. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 30 | -7.41 Units on a scale | Standard Error 1.185 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 60 | -11.8 Units on a scale | Standard Error 1.756 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 42 | -11.2 Units on a scale | Standard Error 1.483 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 90 | -17.4 Units on a scale | Standard Error 2.758 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 12 | -3.17 Units on a scale | Standard Error 1.016 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 90 | -56.9 Units on a scale | Standard Error 1.868 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 12 | -10.2 Units on a scale | Standard Error 1.316 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 30 | -19.9 Units on a scale | Standard Error 1.999 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 42 | -25.4 Units on a scale | Standard Error 2.143 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 60 | -25.1 Units on a scale | Standard Error 3.287 |
Other Pre-specified
Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-clinical summary score was calculated as mean of the following domains- physical limitation and total symptoms and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean.
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54
Population: Safety analysis population included all participants (Cohort B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B | Change at Month 12 | -0.242 Units on a scale | Standard Deviation 17.7032 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B | Change at Month 30 | -3.086 Units on a scale | Standard Deviation 20.4276 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B | Change at Month 54 | -3.988 Units on a scale | Standard Deviation 18.7931 |
Other Pre-specified
Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-overall score was calculated as mean of the following domains- physical limitation, total symptoms (average of symptom frequency & symptom burden), quality of life, social limitation and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as LS mean.
Time frame: B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045)
Population: CMA set was analyzed. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 30 | -6.07 Units on a scale | Standard Error 1.399 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 60 | -8.56 Units on a scale | Standard Error 1.646 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 42 | -8.81 Units on a scale | Standard Error 1.47 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 90 | -18.1 Units on a scale | Standard Error 2.617 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 12 | -1.97 Units on a scale | Standard Error 1.131 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 90 | -52.6 Units on a scale | Standard Error 1.791 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 12 | -9.69 Units on a scale | Standard Error 1.428 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 30 | -19.5 Units on a scale | Standard Error 1.908 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 42 | -24.0 Units on a scale | Standard Error 2.114 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A | Change at Month 60 | -24.5 Units on a scale | Standard Error 3.02 |
Other Pre-specified
Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-overall score was calculated as mean of the following domains- physical limitation, total symptoms (average of symptom frequency & symptom burden), quality of life, social limitation and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean.
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54
Population: Safety analysis population included all participants (Cohort B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B | Change at Month 12 | 0.443 Units on a scale | Standard Deviation 18.2575 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B | Change at Month 30 | -1.378 Units on a scale | Standard Deviation 20.9437 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B | Change at Month 54 | -2.093 Units on a scale | Standard Deviation 19.5085 |
Other Pre-specified
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ Total Symptoms score was calculated as mean of the following domains- symptom frequency and symptom burden and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as LS mean.
Time frame: B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045)
Population: CMA set was analyzed. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 30 | -5.92 Units on a scale | Standard Error 1.279 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 60 | -8.94 Units on a scale | Standard Error 1.858 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 42 | -9.29 Units on a scale | Standard Error 1.699 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 90 | -16.4 Units on a scale | Standard Error 2.654 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 12 | -2.90 Units on a scale | Standard Error 1.182 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 90 | -56.0 Units on a scale | Standard Error 1.958 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 12 | -10.3 Units on a scale | Standard Error 1.494 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 30 | -18.7 Units on a scale | Standard Error 2.276 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 42 | -22.5 Units on a scale | Standard Error 2.237 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A | Change at Month 60 | -19.0 Units on a scale | Standard Error 3.693 |
Other Pre-specified
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ Total Symptoms score was calculated as mean of the following domains- symptom frequency and symptom burden and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean.
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54
Population: Safety analysis population included all participants (Cohort B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B | Change at Month 12 | 0.738 Units on a scale | Standard Deviation 19.1549 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B | Change at Month 30 | -1.112 Units on a scale | Standard Deviation 20.7952 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B | Change at Month 54 | -1.885 Units on a scale | Standard Deviation 19.4433 |
Other Pre-specified
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Modified (m)BMI of participants was calculated to determine if there was any gastrointestinal involvement in participants. The mBMI was calculated by multiplying BMI by serum albumin concentration gram/liter (g/L).
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | -2.96 (kg/m^2) *(g/L) | Standard Deviation 36.046 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -46.43 (kg/m^2) *(g/L) | Standard Deviation 62.394 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -29.31 (kg/m^2) *(g/L) | Standard Deviation 61.003 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | -38.90 (kg/m^2) *(g/L) | Standard Deviation 92.253 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -36.32 (kg/m^2) *(g/L) | Standard Deviation 58.13 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -49.46 (kg/m^2) *(g/L) | Standard Deviation 98.257 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -15.46 (kg/m^2) *(g/L) | Standard Deviation 60.361 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | -7.42 (kg/m^2) *(g/L) | Standard Deviation 49.84 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -41.98 (kg/m^2) *(g/L) | Standard Deviation 74.883 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -15.07 (kg/m^2) *(g/L) | Standard Deviation 58.706 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | -41.20 (kg/m^2) *(g/L) | — |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | -10.91 (kg/m^2) *(g/L) | Standard Deviation 36.338 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | -16.09 (kg/m^2) *(g/L) | Standard Deviation 57.882 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -35.46 (kg/m^2) *(g/L) | Standard Deviation 63.39 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -32.33 (kg/m^2) *(g/L) | Standard Deviation 71.104 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -52.81 (kg/m^2) *(g/L) | Standard Deviation 78.705 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -17.81 (kg/m^2) *(g/L) | Standard Deviation 80.327 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | 1.59 (kg/m^2) *(g/L) | Standard Deviation 69.701 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | 14.05 (kg/m^2) *(g/L) | Standard Deviation 83.969 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -52.80 (kg/m^2) *(g/L) | Standard Deviation 14.562 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -28.06 (kg/m^2) *(g/L) | Standard Deviation 78.987 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -15.81 (kg/m^2) *(g/L) | Standard Deviation 74.009 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | -6.17 (kg/m^2) *(g/L) | Standard Deviation 66.094 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -32.91 (kg/m^2) *(g/L) | Standard Deviation 71.745 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -10.08 (kg/m^2) *(g/L) | Standard Deviation 85.605 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | -8.51 (kg/m^2) *(g/L) | Standard Deviation 51.329 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -24.66 (kg/m^2) *(g/L) | Standard Deviation 74.366 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -15.70 (kg/m^2) *(g/L) | Standard Deviation 79.724 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -51.15 (kg/m^2) *(g/L) | Standard Deviation 79.618 |
Other Pre-specified
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. It was measure in picomole per liter (pmole/L). Higher level of the marker was indicative of heart damage. Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Analysis was performed using Safety analysis population. Number of Participants Analyzed= number of participants evaluable. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed= number of participants evaluable at specified time points. This measurement was not required for participants enrolled before PA-4. This analysis (Cohort A) was based on pooled dose groups, as per SAP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | 159.596 pmole/L | Standard Deviation 404.8483 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | 392.363 pmole/L | Standard Deviation 271.2883 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | 419.034 pmole/L | Standard Deviation 315.6436 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | 322.963 pmole/L | Standard Deviation 215.1605 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | 226.442 pmole/L | — |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | 405.887 pmole/L | Standard Deviation 457.6349 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | 131.334 pmole/L | Standard Deviation 119.5258 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | 31.117 pmole/L | Standard Deviation 220.9279 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | 492.154 pmole/L | Standard Deviation 387.47 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | 314.184 pmole/L | Standard Deviation 274.6756 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | 127.973 pmole/L | Standard Deviation 226.7727 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | 256.442 pmole/L | Standard Deviation 101.8073 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | 417.682 pmole/L | Standard Deviation 597.9224 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | 420.196 pmole/L | Standard Deviation 251.8446 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | 324.211 pmole/L | Standard Deviation 173.6652 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | 400.571 pmole/L | Standard Deviation 228.4343 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | 340.082 pmole/L | Standard Deviation 190.6412 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | 191.318 pmole/L | Standard Deviation 482.3582 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | 92.899 pmole/L | Standard Deviation 320.6054 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | 32.686 pmole/L | Standard Deviation 180.4921 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | 264.566 pmole/L | Standard Deviation 78.7059 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | 71.582 pmole/L | Standard Deviation 329.5411 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | 88.895 pmole/L | Standard Deviation 227.7375 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | 149.049 pmole/L | Standard Deviation 320.8814 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | 24.820 pmole/L | Standard Deviation 171.2075 |
Other Pre-specified
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Troponin I is the cardiac markers. Higher level of the marker was indicative of heart damage. It was measure in nanogram per milliliter (ng/mL). Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Analysis was performed using Safety analysis population.Number of Participants Analyzed=number of participants evaluable.All participants reported underNumber of Participants Analyzedcontributed data to the table;however,may not have evaluable data for every row.Number Analyzed=number of participants evaluable at specified time points.The measurement was not required for participants enrolled before Protocol Amendment4(PA-4).The analysis(Cohort A)was based on pooled dose groups,as per SAP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | 0.022 ng/mL | Standard Deviation 0.1599 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | -0.040 ng/mL | Standard Deviation 0.0414 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -0.002 ng/mL | Standard Deviation 0.0795 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | 0.009 ng/mL | Standard Deviation 0.0579 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | 0.040 ng/mL | — |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -0.033 ng/mL | Standard Deviation 0.0792 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | 0.000 ng/mL | Standard Deviation 0.0566 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | 0.035 ng/mL | Standard Deviation 0.3977 |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | 0.016 ng/mL | Standard Deviation 0.0795 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 60 | 0.035 ng/mL | Standard Deviation 0.0354 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | 0.037 ng/mL | Standard Deviation 0.0853 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | 0.033 ng/mL | Standard Deviation 0.0306 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | 0.100 ng/mL | Standard Deviation 0.1728 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | 0.018 ng/mL | Standard Deviation 0.1057 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -0.047 ng/mL | Standard Deviation 0.0755 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -0.067 ng/mL | Standard Deviation 0.204 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 54 | -0.363 ng/mL | Standard Deviation 0.608 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 42 | -0.021 ng/mL | Standard Deviation 0.2484 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 24 | -0.031 ng/mL | Standard Deviation 0.2031 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 12 | 0.009 ng/mL | Standard Deviation 0.0893 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 48 | -0.100 ng/mL | Standard Deviation 0 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 18 | -0.007 ng/mL | Standard Deviation 0.0786 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 36 | -0.034 ng/mL | Standard Deviation 0.1913 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 30 | -0.033 ng/mL | Standard Deviation 0.2055 |
| Cohort B: Tafamidis (Only in Extension Study) | Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Change at Month 6 | 0.012 ng/mL | Standard Deviation 0.1706 |
Other Pre-specified
Mean Annualized Rate of All Cause Hospitalizations
Mean annual rate of all cause hospitalization was calculated for each participant as the participant's number of all cause hospitalizations divided by this participant's duration on study in years. Hospitalization was defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility or any prolongation of an existing admission. Only all cause hospitalizations where the participant was admitted to a hospital during the current extension study were included in this analysis. Any hospitalizations prior to randomization date were not included.
Time frame: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Population: Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Mean Annualized Rate of All Cause Hospitalizations | 1.67 Hospitalization/year | Standard Deviation 5.83 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Mean Annualized Rate of All Cause Hospitalizations | 1.84 Hospitalization/year | Standard Deviation 2.275 |
| Cohort B: Tafamidis (Only in Extension Study) | Mean Annualized Rate of All Cause Hospitalizations | 0.96 Hospitalization/year | Standard Deviation 5.117 |
Other Pre-specified
Mean Annualized Rate of Cardiovascular (CV)-Related Hospitalizations
Mean annual rate of CV related hospitalization was calculated for each participant as the participant's number of CV related hospitalizations divided by this participant's duration on study in years. CV-related hospitalizations included hospitalizations due to heart failure, arrhythmia, myocardial infarction, stroke, and other cardiovascular-related events. Hospitalization was defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility or any prolongation of an existing admission. Admission also included transfer within the hospital to an acute/intensive care unit (example: from the psychiatric wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a tuberculosis unit).
Time frame: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Population: Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Mean Annualized Rate of Cardiovascular (CV)-Related Hospitalizations | 1.09 CV related hospitalization/year | Standard Deviation 5.409 |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Mean Annualized Rate of Cardiovascular (CV)-Related Hospitalizations | 1.14 CV related hospitalization/year | Standard Deviation 1.899 |
| Cohort B: Tafamidis (Only in Extension Study) | Mean Annualized Rate of Cardiovascular (CV)-Related Hospitalizations | 0.50 CV related hospitalization/year | Standard Deviation 1.567 |
Other Pre-specified
Number of Participants With Cardiovascular Related Mortality Events: Cohort B
Deaths adjudicated as cardiovascular-related and indeterminate were reported. Cardiovascular-related mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Cardiovascular relatedness was based on clinical judgement.
Time frame: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Population: Safety analysis population included all participants who were enrolled in this study and taken at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Cardiovascular Related Mortality Events: Cohort B | 204 Participants |
Other Pre-specified
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
NYHA classification: Class I: Participants with cardiovascular disease (CVD) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; Class II: Participants with CVD resulting in slight limitation of physical activity and were comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina pain; Class III: participants with CVD resulting in marked limitation of physical activity and were comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain; Class IV: participants with CVD resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity was undertaken, discomfort was increased.
Time frame: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Population: Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class III | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class I | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class II | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class II | 12 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class I | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class III | 31 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class II | 14 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class I | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class I | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class II | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class I | 5 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class III | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class II | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class II | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class II | 19 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class II | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class I | 8 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class I | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class II | 49 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class I | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class III | 9 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class I | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class I | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class II | 19 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class III | 24 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class I | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class III | 17 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class I | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class II | 11 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class I | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class I | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class II | 5 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class III | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class II | 7 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class III | 7 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class II | 49 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class I | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class I | 8 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class II | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class II | 14 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class II | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class I | 13 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class III | 10 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class II | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class II | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class I | 7 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class II | 65 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class III | 11 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class I | 5 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class III | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class I | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class II | 3 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class II | 17 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class I | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class III | 34 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class II | 12 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class I | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class III | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class IV | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class I | 10 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class II | 27 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class II | 2 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class II | 5 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class III | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class I | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class I | 6 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class II | 63 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class II | 4 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class III | 10 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class III | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class IV | 1 Participants |
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class I | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class II | 7 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class II | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class III | 9 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class I | 2 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class II | 7 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class II | 2 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class III | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class I | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class II | 2 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class II | 20 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class III | 2 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class II | 9 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class III | 24 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class III | 3 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class IV | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class I | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class II | 16 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class II | 9 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class III | 23 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class I | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class II | 15 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class II | 6 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class III | 19 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class III | 2 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class I | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class II | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class II | 12 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class II | 8 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class III | 14 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class I | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class II | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class I | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class II | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class II | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class I | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class II | 4 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class II | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class III | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class II | 3 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class II | 1 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class II | 2 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 60 | Class II (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class IV | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class II | 129 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class III | 12 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class III | 67 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class II | 371 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class II | 101 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class II (Baseline) to Class I | 50 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class III | 24 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class II | 4 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class III | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class I | 19 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class II | 60 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class III | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class I | 6 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class I (Baseline) to Class I | 94 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class III | 7 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class II | 8 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class IV | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class III | 10 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class II | 22 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class II | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class I | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class IV (Baseline) to Class I | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class II | 54 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class IV | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class I | 26 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class III | 7 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class III | 226 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class II | 88 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class II | 18 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class III (Baseline) to Class I | 4 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class I | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class II | 8 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class IV | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class III | 13 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class III | 100 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class I (Baseline) to Class I | 21 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class II | 542 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class I | 27 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class II (Baseline) to Class I | 60 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class II | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class III | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class III | 8 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 48 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class II | 40 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class II | 70 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class I (Baseline) to Class I | 42 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class I | 31 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class I | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class II | 191 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class III | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class III | 42 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class II | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 6 | Class I (Baseline) to Class I | 132 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class III | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class I | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class II | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class II | 34 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class III | 70 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class III | 46 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class II | 57 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class III (Baseline) to Class I | 5 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class IV | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class III | 61 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class II | 2 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class III | 4 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class II | 259 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 24 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class II (Baseline) to Class I | 41 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class III | 14 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class II (Baseline) to Class III | 24 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class III | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class III | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class I | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class IV (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class II | 45 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class II | 21 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class I | 16 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 18 | Class I (Baseline) to Class I | 64 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class II | 11 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class IV | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class II | 22 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class III | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class III | 7 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class III (Baseline) to Class I | 3 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class I (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class II | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class I (Baseline) to Class II | 32 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class I | 9 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class IV (Baseline) to Class I | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class III | 6 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class II | 77 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class III | 16 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class III | 127 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 30 | Class III (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class II | 67 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 54 | Class II (Baseline) to Class IV | 0 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class I | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 12 | Class III (Baseline) to Class I | 1 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 36 | Class II (Baseline) to Class III | 25 Participants |
| Cohort B: Tafamidis (Only in Extension Study) | Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 | Month 42 | Class III (Baseline) to Class II | 20 Participants |
Other Pre-specified
Time to Cardiovascular-Related Mortality Events: Cohort A
Time to cardiovascular-related mortality was calculated from first dose of randomized treatment in B3461028 . Participants who discontinued for transplantation (that is heart transplantation and combined heart and liver transplantation) or for implantation of cardiac mechanical assist device were treated as a death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Kaplan-Meier method was used. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
Time frame: From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months]
Population: CMA set included all participants in the ITT analysis set from study B3461028 (NCT01994889). Mortality analyses in study B3461045 for Cohort A participants were combined data from participants in study B3461028 (NCT01994889), including participants who died, discontinued in B3461028, or were not enrolled into B3461045 (i.e. ITT Analysis Set from B3461028 \[NCT01994889\]) with mortality data through participation in the B3461045 study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study) | Time to Cardiovascular-Related Mortality Events: Cohort A | 70.2 Months |
| Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study) | Time to Cardiovascular-Related Mortality Events: Cohort A | 40.8 Months |
p-value: 0.000595% CI: [0.4666, 0.8062]Cox Proportional Hazards model