ATTR-CM, TTR-CM
Conditions
Keywords
TTR, ATTR, cardiomyopathy, amyloidosis, tafamidis
Brief summary
Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type Transthyretin (ttr) Amyloid Cardiomyopathy. Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on Day 0, patients will have their entrance criteria reviewed, and medical histories and demographic characteristics obtained. The physical examination (including weight and vital signs) and the relevant end of study clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than 30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical laboratory assessments must be performed on Day 0. Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e., first dose) and will return to the clinical unit for study visits every 6 months. Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated physical examinations (including weight and vital signs) will also be performed at each 6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone call will be made at 3-month intervals between clinic visits to assess safety and use of concomitant medications. For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ, 6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition, echocardiograms will be performed every 12 months on an annual basis. An end of study visit including all safety and efficacy assessments will occur upon patient completion of the study, premature withdrawal (for any reason), or in the event of program discontinuation by the Sponsor.
Interventions
DRUGtafamidis
Once daily 20 mg oral tafamidis (soft gelatin capsule)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient successfully completed Protocol Fx1B-201. * If female; patient is post menopausal. If male, female partner is post-menopausal. If female is of child bearing potential, willing to use acceptable method of birth control up to 3 months after last dose (included female partners of male participants). * Patient is willing to comply with protocol.
Exclusion criteria
* Patient did not successfully complete Fx1B-201. * Chronic use of NSAIDS. * Patient has a clinically significant medication condition that increases risk of study participation. * Patient has received heart or liver transplant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Levels of Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) at Month 60 | Baseline, Month 60 | NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress). |
| Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Month 12 | Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, How do you feel today as compared to when we talked with you at your last clinic visit for this study? and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened. |
| Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Month 60 | Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, How do you feel today as compared to when we talked with you at your last clinic visit for this study? and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened. |
| Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline | Baseline | NYHA classified participants in 4 classes. Class I included participants with cardiac disease without limitations of physical activity. Ordinary physical activity did not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II included participants with cardiac disease with slight limitation of physical activity. They were comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea, or anginal pain. Class III included participants with cardiac disease with marked limitation of physical activity. They were comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea, or anginal pain. Class IV included participants with cardiac disease with the inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. |
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 | Baseline, Month 12 | NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class). |
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 | Baseline, Month 60 | NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class). |
| Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Baseline, Month 12 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated. |
| Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Baseline, Month 60 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated. |
| Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Month 12 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked less than (\<) 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked greater than or equal to (\>=) 450 meter. |
| Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Month 60 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked \< 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked \>=450 meter. |
| Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Baseline, Month 12 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at Month 12. |
| Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Baseline, Month 60 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at Month 60. |
| Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Baseline, Month 12 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'. |
| Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Baseline, Month 60 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'. |
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 | Baseline, Month 12 | KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status. |
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60 | Baseline, Month 60 | KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status. |
| Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 | Baseline, Month 12 | Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage. |
| Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60 | Baseline, Month 60 | Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage. |
| Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12 | Baseline, Month 12 | NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular \[LV\] wall stress). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132 | NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class). |
| Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated. |
| Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked \< 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked \>=450 meter. |
| Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at specified visits. |
| Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132 | 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'. |
| Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132 | KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status. |
| Number of Participants With Abnormalities in Echocardiography | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | Echocardiography abnormalities included: absent respiratory variation of inferior vena cava, any valve thickening, aortic valve thickening, decreased respiratory variation of inferior vena cava, dilated inferior vena cava, E deceleration time less than or equal to (\<=) 150 millisecond, E wave/A Wave (E/A) ratio \>=2, ejection fraction \< 50%, isovolumic relaxation time (IVRT) \<=70 millisecond, left ventricular posterior wall thickness \>=13 millimeter (mm), left ventricular septal thickness \>= 13 mm, mitral valve thickening, pericardial effusion, pulmonary valve thickening, right ventricular thickness \>=7 mm, tricuspid valve thickening, ratio between early mitral inflow velocity and mitral annular early diastolic velocity (e/e') Lateral greater than (\>) 15, e/e' Septal \>15. |
| Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage. |
| Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 | NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress). |
| Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | All cause hospitalization was defined as any serious adverse event, which resulted in hospitalization. Cardiac-related hospitalization was any hospitalization meeting the following criteria: cardiac disorders or AE preferred term as chest discomfort, chest pain, death, cerebrovascular accident, embolic stroke, disease progression. |
| Time to All-cause Mortality and Cardiac-Related Mortality | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | Time to death for all participants with a death date in Clinical Database, or censored at the last dose date + 28 days for those participants who were alive at the end of the study is reported. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events. |
| Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events. Relatedness to study drug was assessed by the investigator as (Yes/No). |
| Number of Participants With Clinically Significant Physical Examination Findings | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | Physical examination included examination of general appearance, endocrine, head and neck, cardiovascular, eyes, abdomen, ears, skin, nose, musculoskeletal, throat, neurological, respiratory, immunologic/allergies, genitourinary, hematologic/lymphatic. Clinical significance of any physical examination finding was judged by investigator. |
| Number of Participants With Any Concomitant Medications | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | Number of participants who used medication other than study drug were reported. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | ECG parameters included PR interval (millisecond), RR interval (millisecond), QRS interval (millisecond), QT and QTc interval (millisecond) and heart rate (beats per minute). Clinical significance of any ECG finding was judged by investigator. |
| Number of Participants With Laboratory Abnormalities | Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303 | Laboratory parameters included hematology and biochemistry: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, gamma glutamyl transferase (GGT), creatinine, total bilirubin, international normalized ratio (INR), troponin I, troponin T, prothrombin time, sodium, globulin potassium, chloride, bicarbonate, cholesterol, calcium, uric acid, inorganic phosphorous, thyroid-stimulating hormone, glucose, total thyroxine (T4), free T4, total proteins, prealbumin (transthyretin), albumin, hemoglobin, platelets, hematocrit, white blood cell count, red blood cell count, neutrophils, packed cell volume, lymphocytes, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, eosinophils, mean corpuscular hemoglobin concentration, basophils, retinol-binding protein, Urinalysis: bilirubin, pH, blood (free Hb), protein, nitrite, glucose, urobilinogen, ketones, specific gravity. |
| Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132 | Participants overall quality of life was measured by PGA. At each follow-up visit, participants were asked, How do you feel today as compared to when we talked with you at your last clinic visit for this study? and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened. |
Countries
United States
Participant flow
Recruitment details
Participants with transthyretin amyloid cardiomyopathy (TTR-CM/ATTR-CM), who had not undergone liver or heart transplantation and who had completed previous study Fx1B-201 (NCT00694161) were eligible to enter this current study Fx1B-303 (NCT00935012).
Pre-assignment details
In this study, participants continued on same dose they had received in initial study. Data for time points from Baseline to Month 12 are from study Fx1B-201, while data for time points after Month 12 are from study Fx1B-303.
Participants by arm
| Arm | Count |
|---|---|
| Tafamidis 20 mg Participants received tafamidis 20 milligram (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study (Fx1B-303) or until they had an access to tafamidis for TTR-CM via prescription, upon regulatory approval in respective countries. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 19 |
| Overall Study | Other | 5 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Tafamidis 20 mg |
|---|---|
| Age, Continuous | 77.6 years STANDARD_DEVIATION 4.89 |
| Race/Ethnicity, Customized African American | 3 Participants |
| Race/Ethnicity, Customized Afro-caribbean | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 27 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 31 |
| other Total, other adverse events | 30 / 31 |
| serious Total, serious adverse events | 29 / 31 |
Outcome results
Primary
Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12
NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ left ventricular \[LV\] wall stress).
Time frame: Baseline, Month 12
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12 | Baseline | 4526.1 nanogram per milliliter | Standard Deviation 3814.21 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Month 12 | Change at Month 12 | 818.3 nanogram per milliliter | Standard Deviation 3133.86 |
Primary
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at Month 12.
Time frame: Baseline, Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Dyspnea: Baseline, Pre walk | 0.6 units on a scale | Standard Deviation 0.72 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Dyspnea: Baseline, Post walk | 2.5 units on a scale | Standard Deviation 1.94 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Dyspnea: Baseline, Within Visit Difference | 1.9 units on a scale | Standard Deviation 1.94 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Dyspnea: Change at Month 12, Pre walk | 0.6 units on a scale | Standard Deviation 1.61 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Dyspnea: Change at Month 12, Post walk | 1.2 units on a scale | Standard Deviation 1.6 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Dyspnea:Change at Month 12,Within Visit Difference | 0.6 units on a scale | Standard Deviation 1.7 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Fatigue: Baseline, Pre-walk | 0.9 units on a scale | Standard Deviation 1.27 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Fatigue: Baseline, Post-walk | 2.4 units on a scale | Standard Deviation 2.06 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Fatigue: Baseline, Within Visit Difference | 1.4 units on a scale | Standard Deviation 2.51 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Fatigue: Change at Month 12, Pre Walk | 0.5 units on a scale | Standard Deviation 2.2 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Fatigue: Change at Month 12, Post-Walk | 0.9 units on a scale | Standard Deviation 1.98 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 12 | Fatigue:Change at Month 12,Within Visit Difference | 0.4 units on a scale | Standard Deviation 2.2 |
Primary
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at Month 60.
Time frame: Baseline, Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Dyspnea: Change at Month 60, Pre walk | 0.8 units on a scale | Standard Deviation 1.41 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Dyspnea: Change at Month 60, Post walk | 0.8 units on a scale | Standard Deviation 1.6 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Dyspnea:Change at Month 60,Within Visit Difference | 0.1 units on a scale | Standard Deviation 1.94 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Fatigue: Change at Month 60, Pre walk | 0.1 units on a scale | Standard Deviation 0.35 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Fatigue: Change at Month 60, Post walk | 0.4 units on a scale | Standard Deviation 1.51 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Month 60 | Fatigue:Change at Month 60,Within Visit Difference | 0.3 units on a scale | Standard Deviation 1.49 |
Primary
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12
KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status.
Time frame: Baseline, Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 | Overall Summary Score: Baseline | 72.21 units on a scale | Standard Deviation 18.974 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 | Overall Summary Score: Change at Month 12 | -4.54 units on a scale | Standard Deviation 12.724 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 | Clinical Summary Score: Baseline | 74.79 units on a scale | Standard Deviation 19.296 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 12 | Clinical Summary Score: Change at Month 12 | -5.60 units on a scale | Standard Deviation 13.792 |
Primary
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60
KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status.
Time frame: Baseline, Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60 | Overall Summary Score: Change at Month 60 | -12.93 units on a scale | Standard Deviation 29.306 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Month 60 | Clinical Summary Score: Change at Month 60 | -18.12 units on a scale | Standard Deviation 29.432 |
Primary
Change From Baseline in Serum Levels of Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) at Month 60
NT-proBNP is biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).
Time frame: Baseline, Month 60
Population: Safety analysis population consisted of all participants who were enrolled in this study and who had taken at least one dose of study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Serum Levels of Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) at Month 60 | 5127.6 nanogram per milliliter | Standard Deviation 10598.94 |
Primary
Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated.
Time frame: Baseline, Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed=participants evaluable for this outcome measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Baseline | 363.7 meters | Standard Deviation 130.8 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Change at Month 12 | -11.2 meters | Standard Deviation 76.39 |
Primary
Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated.
Time frame: Baseline, Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | -121.4 meters | Standard Deviation 145.82 |
Primary
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12
Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage.
Time frame: Baseline, Month 12
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 | Troponin I: Change at Month 12 | 0.016 nanogram per milliliter | Standard Deviation 0.0652 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 | Troponin I: Baseline | 0.132 nanogram per milliliter | Standard Deviation 0.0627 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 | Troponin T: Baseline | 0.0448 nanogram per milliliter | Standard Deviation 0.03402 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Month 12 | Troponin T: Change at Month 12 | 0.0110 nanogram per milliliter | Standard Deviation 0.02239 |
Primary
Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60
Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage.
Time frame: Baseline, Month 60
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60 | Troponin T: Change at Month 60 | 0.026 nanogram per milliliter | Standard Deviation 0.0937 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Month 60 | Troponin I: Change at Month 60 | 0.0810 nanogram per milliliter | Standard Deviation 0.17779 |
Primary
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked less than (\<) 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked greater than or equal to (\>=) 450 meter.
Time frame: Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Level 1 | 8 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Level 2 | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Level 3 | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Level 4 | 6 Participants |
Primary
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked \< 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked \>=450 meter.
Time frame: Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Level 1 | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Level 2 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Level 4 | 1 Participants |
Primary
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'.
Time frame: Baseline, Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Worsened | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Unchanged | 16 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 12 | Improved | 5 Participants |
Primary
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'.
Time frame: Baseline, Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Worsened | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Unchanged | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 60 | Improved | 0 Participants |
Primary
Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline
NYHA classified participants in 4 classes. Class I included participants with cardiac disease without limitations of physical activity. Ordinary physical activity did not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II included participants with cardiac disease with slight limitation of physical activity. They were comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea, or anginal pain. Class III included participants with cardiac disease with marked limitation of physical activity. They were comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea, or anginal pain. Class IV included participants with cardiac disease with the inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased.
Time frame: Baseline
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline | CLASS I | 4 Participants |
| Tafamidis 20 mg | Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline | CLASS II | 26 Participants |
| Tafamidis 20 mg | Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline | CLASS III | 1 Participants |
| Tafamidis 20 mg | Number of Participants Classified on the Basis of New York Heart Association (NYHA) Classification at Baseline | CLASS IV | 0 Participants |
Primary
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12
NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Time frame: Baseline, Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 | Worsened | 7 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 | Unchanged | 20 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 12 | Improved | 4 Participants |
Primary
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60
NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Time frame: Baseline, Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Here, Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 | Worsened | 8 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 | Unchanged | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Month 60 | Improved | 1 Participants |
Primary
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12
Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, How do you feel today as compared to when we talked with you at your last clinic visit for this study? and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Time frame: Month 12
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Moderately Improved | 16.1 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Mildly Improved | 9.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Unchanged | 51.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Mildly Worsened | 12.9 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Moderately Worsened | 9.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 12 | Markedly Worsened | 0 percentage of participants |
Primary
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60
Participants overall quality of life was measured by PGA. At follow-up visit, participants were asked, How do you feel today as compared to when we talked with you at your last clinic visit for this study? and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Time frame: Month 60
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Moderately Improved | 8.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Mildly Improved | 8.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Unchanged | 50.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Mildly Worsened | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Moderately Worsened | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Month 60 | Markedly Worsened | 0 percentage of participants |
Secondary
Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126
NT-proBNP was biomarker of cardiac stress (myocardial necrosis and increased filling pressures/ LV wall stress).
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 6 | 66.0 nanogram per milliliter | Standard Deviation 2164.66 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 18 | 492.0 nanogram per milliliter | Standard Deviation 2455.65 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 24 | 211.5 nanogram per milliliter | Standard Deviation 2119.01 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 30 | 701.8 nanogram per milliliter | Standard Deviation 2423.16 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 36 | 1063.5 nanogram per milliliter | Standard Deviation 2813.85 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 42 | 2510.2 nanogram per milliliter | Standard Deviation 5143.47 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 48 | 3761.2 nanogram per milliliter | Standard Deviation 7892.8 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 54 | 1668.1 nanogram per milliliter | Standard Deviation 2677.27 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 66 | 433.3 nanogram per milliliter | Standard Deviation 493.76 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 72 | 625.5 nanogram per milliliter | Standard Deviation 471.41 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 78 | 707.7 nanogram per milliliter | Standard Deviation 236.53 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 84 | 348.5 nanogram per milliliter | Standard Deviation 700.98 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 90 | 283.7 nanogram per milliliter | Standard Deviation 971.53 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 96 | 1453.0 nanogram per milliliter | Standard Deviation 2193.75 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 102 | 1439.0 nanogram per milliliter | Standard Deviation 2032.43 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 108 | 346.4 nanogram per milliliter | Standard Deviation 1279.58 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 114 | 465.7 nanogram per milliliter | Standard Deviation 790.48 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 120 | 1232.0 nanogram per milliliter | Standard Deviation 667.51 |
| Tafamidis 20 mg | Change From Baseline in Amino-Terminal B-type Natriuretic Peptide (NT-proBNP) Serum Level at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Change at Month 126 | 1249.0 nanogram per milliliter | — |
Secondary
Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. Dyspnea: participants were asked to rate the difficulty of their breathing, pre-walk and post-walk at each visit, on a scale of range 0 (no breathlessness at all) to 10 (maximum breathlessness). Higher scores indicated more severity. Fatigue: participants were asked to rate the how tired they felt, pre-walk and post-walk at each visit, on a scale of range 0 (not at all) to 10 (maximal) Higher scores indicated more fatigue. At each visit, scores for pre-walk test, post-walk test and within visit difference (difference from post-walk to pre-walk) were evaluated. Change from baseline was calculated for each pre-walk test, post-walk test and within visit difference at specified visits.
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed=participants evaluable for this outcome measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 6, Pre walk | 0.3 units on a scale | Standard Deviation 1.32 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 6, Post walk | 0.9 units on a scale | Standard Deviation 1.54 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 6,Within Visit Difference | 0.6 units on a scale | Standard Deviation 1.56 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 18, Pre walk | 0.3 units on a scale | Standard Deviation 1.11 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 18,Within Visit Difference | 0.6 units on a scale | Standard Deviation 1.93 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 24, Pre walk | 0.3 units on a scale | Standard Deviation 0.75 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 24, Post walk | 1.5 units on a scale | Standard Deviation 1.91 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 24,Within Visit Difference | 1.1 units on a scale | Standard Deviation 2.02 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 30, Pre walk | 0.2 units on a scale | Standard Deviation 0.47 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 30, Post walk | 1.2 units on a scale | Standard Deviation 1.27 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 30,Within Visit Difference | 1.0 units on a scale | Standard Deviation 1.36 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 36, Pre walk | 0.1 units on a scale | Standard Deviation 1.36 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 36, Post walk | -0.2 units on a scale | Standard Deviation 2.68 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 36,Within Visit Difference | -0.3 units on a scale | Standard Deviation 1.97 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 42, Pre walk | 0.5 units on a scale | Standard Deviation 0.9 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 42, Post walk | 1.0 units on a scale | Standard Deviation 1.45 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 42,Within Visit Difference | 0.5 units on a scale | Standard Deviation 1.53 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 48, Pre walk | 0.6 units on a scale | Standard Deviation 1.17 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 48, Post walk | 1.3 units on a scale | Standard Deviation 0.98 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 48,Within Visit Difference | 0.8 units on a scale | Standard Deviation 1.64 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 54, Pre walk | 0.4 units on a scale | Standard Deviation 1.56 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 54, Post walk | 1.0 units on a scale | Standard Deviation 1.93 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 54,Within Visit Difference | 0.6 units on a scale | Standard Deviation 1.91 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 66, Pre walk | 1.4 units on a scale | Standard Deviation 1.11 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 66, Post walk | 1.5 units on a scale | Standard Deviation 1.29 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 66,Within Visit Difference | 0.1 units on a scale | Standard Deviation 1.18 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 72, Pre walk | 0.8 units on a scale | Standard Deviation 1.44 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 72, Post walk | 0.7 units on a scale | Standard Deviation 1.15 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 72,Within Visit Difference | -0.2 units on a scale | Standard Deviation 0.29 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 78, Pre walk | 2.2 units on a scale | Standard Deviation 2.02 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 78, Post walk | 0.7 units on a scale | Standard Deviation 0.58 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 78,Within Visit Difference | -1.5 units on a scale | Standard Deviation 1.5 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 84, Pre walk | -0.1 units on a scale | Standard Deviation 0.85 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 84, Post walk | 0.5 units on a scale | Standard Deviation 1 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 84,Within Visit Difference | 0.6 units on a scale | Standard Deviation 1.7 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 90, Pre walk | 0.6 units on a scale | Standard Deviation 0.66 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 90, Post walk | -0.8 units on a scale | Standard Deviation 2.32 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 90,Within Visit Difference | -1.4 units on a scale | Standard Deviation 2.2 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 96, Pre walk | 1.0 units on a scale | Standard Deviation 1.41 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 96, Post walk | 1.3 units on a scale | Standard Deviation 1.5 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month 96,Within Visit Difference | 0.3 units on a scale | Standard Deviation 2.36 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 102, Pre walk | -0.3 units on a scale | Standard Deviation 0.58 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 102, Post walk | -1.3 units on a scale | Standard Deviation 4.04 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month102,Within Visit Difference | -1.0 units on a scale | Standard Deviation 3.46 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 108, Pre walk | 1.7 units on a scale | Standard Deviation 2.82 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 108, Post walk | 0.7 units on a scale | Standard Deviation 4.97 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month108,Within Visit Difference | -1.0 units on a scale | Standard Deviation 2.81 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 114, Pre walk | 0.4 units on a scale | Standard Deviation 1.8 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 114, Post walk | 0.1 units on a scale | Standard Deviation 0.63 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month114,Within Visit Difference | -0.3 units on a scale | Standard Deviation 1.19 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 120, Pre walk | 0.3 units on a scale | Standard Deviation 1.53 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 120, Post walk | -0.8 units on a scale | Standard Deviation 1.04 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month120,Within Visit Difference | -1.2 units on a scale | Standard Deviation 2.47 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 132, Pre walk | -1.0 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 132, Post walk | -1.0 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea:Change at Month132,Within Visit Difference | 0.0 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 6, Pre walk | 0.2 units on a scale | Standard Deviation 1.69 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 6, Post walk | 0.7 units on a scale | Standard Deviation 2.82 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 6,Within Visit Difference | 0.4 units on a scale | Standard Deviation 2.92 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 18, Pre walk | 0.0 units on a scale | Standard Deviation 2.13 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 18, Post walk | 0.2 units on a scale | Standard Deviation 1.4 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 18,Within Visit Difference | 0.2 units on a scale | Standard Deviation 2.51 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 24, Pre walk | 0.1 units on a scale | Standard Deviation 1.66 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 24, Post walk | 1.0 units on a scale | Standard Deviation 2.33 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 24,Within Visit Difference | 0.9 units on a scale | Standard Deviation 2.97 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 30, Pre walk | -0.4 units on a scale | Standard Deviation 1.58 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 30, Post walk | 0.9 units on a scale | Standard Deviation 1.65 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 30,Within Visit Difference | 1.3 units on a scale | Standard Deviation 2.23 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 36, Pre walk | -0.2 units on a scale | Standard Deviation 2.29 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 36, Post walk | 0.8 units on a scale | Standard Deviation 2.05 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 36,Within Visit Difference | 1.0 units on a scale | Standard Deviation 2.76 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 42, Pre walk | 0.4 units on a scale | Standard Deviation 1.76 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 42, Post walk | 1.6 units on a scale | Standard Deviation 1.86 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 42,Within Visit Difference | 1.2 units on a scale | Standard Deviation 2.86 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 48, Pre walk | 0.6 units on a scale | Standard Deviation 1.26 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 48, Post walk | 1.5 units on a scale | Standard Deviation 1.84 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 48,Within Visit Difference | 0.9 units on a scale | Standard Deviation 2.38 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 54, Pre walk | 0.5 units on a scale | Standard Deviation 1.57 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 54, Post walk | 0.5 units on a scale | Standard Deviation 1.9 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 54,Within Visit Difference | -0.1 units on a scale | Standard Deviation 1.97 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 66, Pre walk | 0.3 units on a scale | Standard Deviation 0.5 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 66, Post walk | 0.5 units on a scale | Standard Deviation 2.38 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 66,Within Visit Difference | 0.3 units on a scale | Standard Deviation 2.22 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 72, Pre walk | 2.0 units on a scale | Standard Deviation 1.73 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 72, Post walk | 1.0 units on a scale | Standard Deviation 1.73 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 72,Within Visit Difference | -1.0 units on a scale | Standard Deviation 0 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 78, Pre walk | 2.0 units on a scale | Standard Deviation 2 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 78, Post walk | 1.0 units on a scale | Standard Deviation 2.65 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 78,Within Visit Difference | -1.0 units on a scale | Standard Deviation 1 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 84, Pre walk | 0.0 units on a scale | Standard Deviation 0.82 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 84, Post walk | 0.4 units on a scale | Standard Deviation 1.11 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 84,Within Visit Difference | 0.4 units on a scale | Standard Deviation 1.49 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 90, Pre walk | 1.3 units on a scale | Standard Deviation 1.75 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 90, Post walk | -0.3 units on a scale | Standard Deviation 2.07 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 90,Within Visit Difference | -1.7 units on a scale | Standard Deviation 3.27 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 96, Pre walk | 0.8 units on a scale | Standard Deviation 1.5 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 96, Post walk | 0.0 units on a scale | Standard Deviation 0.82 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month 96,Within Visit Difference | -0.8 units on a scale | Standard Deviation 1.71 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 102, Pre walk | 1.0 units on a scale | Standard Deviation 2.65 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 102, Post walk | -0.7 units on a scale | Standard Deviation 1.53 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month102,Within Visit Difference | -1.7 units on a scale | Standard Deviation 1.15 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 108, Pre walk | 1.8 units on a scale | Standard Deviation 2.77 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 108, Post walk | 0.9 units on a scale | Standard Deviation 3.54 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month108,Within Visit Difference | -0.9 units on a scale | Standard Deviation 1.14 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 114, Pre walk | 1.0 units on a scale | Standard Deviation 2.16 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 114, Post walk | -0.1 units on a scale | Standard Deviation 0.85 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month114,Within Visit Difference | -1.1 units on a scale | Standard Deviation 1.44 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 120, Pre walk | 0.0 units on a scale | Standard Deviation 1 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 120, Post walk | -1.2 units on a scale | Standard Deviation 0.76 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month120,Within Visit Difference | -1.2 units on a scale | Standard Deviation 1.76 |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 132, Pre walk | -1.0 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue: Change at Month 132, Post walk | -0.5 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Fatigue:Change at Month132,Within Visit Difference | 0.5 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Dyspnea and Fatigue Scores During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Dyspnea: Change at Month 18, Post walk | 0.8 units on a scale | Standard Deviation 1.4 |
Secondary
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: physical limitation, social limitation, quality of life, self-efficacy, symptom stability, symptom frequency, symptom burden, and total symptoms (calculated as the mean of symptom frequency and symptom burden scores). Two summary scores were calculated: clinical summary (calculated as mean of physical limitation and total symptom scores) and overall summary (calculated as mean of physical limitation, social limitation, total symptoms, and quality of life scores). Each domain and both summary scores were scaled to range from 0 (worse health status) to 100 (best health status); higher scores represented better health status.
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 6 | -2.12 units on a scale | Standard Deviation 12.423 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 18 | -4.58 units on a scale | Standard Deviation 18.926 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 24 | -2.94 units on a scale | Standard Deviation 16.247 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 30 | -5.41 units on a scale | Standard Deviation 17.695 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 36 | -6.86 units on a scale | Standard Deviation 18.525 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 42 | -12.76 units on a scale | Standard Deviation 23.646 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 48 | -13.22 units on a scale | Standard Deviation 24.893 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 54 | -14.99 units on a scale | Standard Deviation 23.688 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 66 | -1.77 units on a scale | Standard Deviation 30.476 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 72 | 0.41 units on a scale | Standard Deviation 23.317 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 78 | -3.60 units on a scale | Standard Deviation 24.231 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 84 | -3.72 units on a scale | Standard Deviation 32.77 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 90 | -0.28 units on a scale | Standard Deviation 30.296 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 96 | -17.84 units on a scale | Standard Deviation 47.842 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 102 | -12.63 units on a scale | Standard Deviation 40.904 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 108 | -1.19 units on a scale | Standard Deviation 35.375 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 114 | -2.99 units on a scale | Standard Deviation 37.897 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 120 | -35.55 units on a scale | Standard Deviation 9.023 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 126 | -39.32 units on a scale | Standard Deviation 8.102 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Overall Summary Score: Change at Month 132 | -40.10 units on a scale | — |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 6 | -3.00 units on a scale | Standard Deviation 11.65 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 18 | -6.66 units on a scale | Standard Deviation 17.34 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 24 | -2.87 units on a scale | Standard Deviation 15.875 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 30 | -7.80 units on a scale | Standard Deviation 17.497 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 36 | -9.53 units on a scale | Standard Deviation 17.7 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 42 | -17.05 units on a scale | Standard Deviation 22.804 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 48 | -15.67 units on a scale | Standard Deviation 24.854 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 54 | -16.90 units on a scale | Standard Deviation 21.295 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 66 | -3.45 units on a scale | Standard Deviation 27.219 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 72 | -1.82 units on a scale | Standard Deviation 21.558 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 78 | -7.13 units on a scale | Standard Deviation 22.422 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 84 | -6.53 units on a scale | Standard Deviation 29.881 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 90 | -2.47 units on a scale | Standard Deviation 24.198 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 96 | -19.27 units on a scale | Standard Deviation 42.768 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 102 | -15.10 units on a scale | Standard Deviation 31.69 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 108 | -3.26 units on a scale | Standard Deviation 27.764 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 114 | -4.69 units on a scale | Standard Deviation 32.213 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 120 | -42.45 units on a scale | Standard Deviation 11.417 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 126 | -38.02 units on a scale | Standard Deviation 14.731 |
| Tafamidis 20 mg | Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Clinical Summary Score: Change at Month 132 | -40.63 units on a scale | — |
Secondary
Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, the total distance that a participant could walk in 6 minutes was evaluated.
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 6 | 2.9 meters | Standard Deviation 60.64 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 18 | -21.6 meters | Standard Deviation 108.19 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 24 | -15.7 meters | Standard Deviation 78.39 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 30 | -44.5 meters | Standard Deviation 111.67 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 36 | -63.5 meters | Standard Deviation 101.37 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 42 | -95.2 meters | Standard Deviation 124.79 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 48 | -110.9 meters | Standard Deviation 128.57 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 54 | -127.8 meters | Standard Deviation 124.01 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 66 | -63.2 meters | Standard Deviation 114.2 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 72 | -139.5 meters | Standard Deviation 210.18 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 78 | -94.3 meters | Standard Deviation 177.01 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 84 | -100.3 meters | Standard Deviation 151.71 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 90 | -97.6 meters | Standard Deviation 125.5 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 96 | -118.9 meters | Standard Deviation 114.2 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 102 | -82.3 meters | Standard Deviation 19.3 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 108 | -141.9 meters | Standard Deviation 112.29 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 114 | -166.9 meters | Standard Deviation 137.23 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 120 | -184.5 meters | Standard Deviation 82.22 |
| Tafamidis 20 mg | Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Change at Month 132 | -289.6 meters | — |
Secondary
Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126
Troponin I and troponin T are the cardiac markers. Troponin I and troponin T are part of the troponin complex, where troponin I is bound to actin in thin myofilaments and troponin T is bound to tropomyosin. Higher level of these markers is indicative of heart damage.
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 6 | -0.016 nanogram per milliliter | Standard Deviation 0.0533 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 18 | 0.032 nanogram per milliliter | Standard Deviation 0.1307 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 24 | 0.023 nanogram per milliliter | Standard Deviation 0.0986 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 30 | 0.022 nanogram per milliliter | Standard Deviation 0.1038 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 36 | 0.029 nanogram per milliliter | Standard Deviation 0.1099 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 42 | 0.042 nanogram per milliliter | Standard Deviation 0.1409 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 48 | 0.058 nanogram per milliliter | Standard Deviation 0.1409 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 54 | 0.042 nanogram per milliliter | Standard Deviation 0.1226 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 66 | -0.012 nanogram per milliliter | Standard Deviation 0.0133 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 72 | -0.010 nanogram per milliliter | Standard Deviation 0.0183 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 78 | -0.013 nanogram per milliliter | Standard Deviation 0.0208 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 84 | -0.008 nanogram per milliliter | Standard Deviation 0.0096 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 90 | -0.003 nanogram per milliliter | Standard Deviation 0.0293 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 96 | -0.008 nanogram per milliliter | Standard Deviation 0.015 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 102 | -0.010 nanogram per milliliter | Standard Deviation 0.0356 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 108 | 0.000 nanogram per milliliter | Standard Deviation 0.0071 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 114 | 0.000 nanogram per milliliter | Standard Deviation 0.0271 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 120 | 0.000 nanogram per milliliter | Standard Deviation 0.0141 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin I: Change at Month 126 | 0.005 nanogram per milliliter | Standard Deviation 0.0354 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 6 | -0.0007 nanogram per milliliter | Standard Deviation 0.0171 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 18 | 0.0271 nanogram per milliliter | Standard Deviation 0.07429 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 24 | 0.0132 nanogram per milliliter | Standard Deviation 0.03286 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 30 | 0.0166 nanogram per milliliter | Standard Deviation 0.02227 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 36 | 0.0205 nanogram per milliliter | Standard Deviation 0.03049 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 42 | 0.0329 nanogram per milliliter | Standard Deviation 0.05665 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 48 | 0.0510 nanogram per milliliter | Standard Deviation 0.09562 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 54 | 0.0562 nanogram per milliliter | Standard Deviation 0.13264 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 66 | 0.0050 nanogram per milliliter | Standard Deviation 0.02588 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 72 | -0.0055 nanogram per milliliter | Standard Deviation 0.01714 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 78 | 0.0000 nanogram per milliliter | Standard Deviation 0.01732 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 84 | -0.0003 nanogram per milliliter | Standard Deviation 0.01415 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 90 | 0.0026 nanogram per milliliter | Standard Deviation 0.00962 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 96 | -0.0037 nanogram per milliliter | Standard Deviation 0.00551 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 102 | 0.0098 nanogram per milliliter | Standard Deviation 0.01461 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 108 | 0.0100 nanogram per milliliter | Standard Deviation 0.00707 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month114 | 0.0100 nanogram per milliliter | Standard Deviation 0.00816 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 120 | 0.0150 nanogram per milliliter | Standard Deviation 0.02121 |
| Tafamidis 20 mg | Change From Baseline in Troponin I and Troponin T Serum Levels at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 126 | Troponin T: Change at Month 126 | 0.0000 nanogram per milliliter | — |
Secondary
Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants were categorized based on the total distance walked as Level 1 = total distance walked \< 300 meter; Level 2 = total distance walked between 300 to 374.9 meter; Level 3 = total distance walked between 375 to 449.9 meter; Level 4 = total distance walked \>=450 meter.
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Level 1 | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Level 2 | 9 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Level 1 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Level 2 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Level 1 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Level 2 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Level 1 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Level 2 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Level 1 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Level 2 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline: Level 1 | 8 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline: Level 2 | 10 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline: Level 3 | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Baseline: Level 4 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Level 3 | 9 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Level 4 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18:Level 1 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Level 2 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Level 3 | 8 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Level 4 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Level 1 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Level 2 | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Level 3 | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Level 4 | 6 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Level 1 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Level 2 | 6 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Level 3 | 6 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Level 4 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Level 1 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Level 2 | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Level 3 | 6 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Level 4 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Level 1 | 9 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Level 2 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Level 3 | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Level 4 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Level 1 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Level 2 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Level 3 | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Level 1 | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Level 2 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Level 3 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Level 4 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Level 1 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Level 2 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Level 3 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Level 1 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Level 2 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Level 3 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Level 1 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Level 2 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Level 3 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Level 1 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Level 2 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Level 1 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Level 2 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Level 3 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Level 4 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Level 1 | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Level 2 | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Level 3 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Level 1 | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Level 2 | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized Based on Total Distance Walked During 6 Minute Walk Test (6MWT) at Baseline, Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Level 3 | 1 Participants |
Secondary
Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132
6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants were asked to walk as far as possible for 6 minutes at a pace that was comfortable to them, and were permitted to slow down, to stop, and to rest as necessary. In this outcome measure, participants on basis of change from baseline in total distance walked were categorized as worsened, unchanged or improved. If distance walked at a visit was greater than distance walked at baseline, then categorized as 'improved'. If distance walked at a visit was equal to distance walked at baseline, then categorized as 'unchanged'. If distance walked at a visit was less than distance walked at baseline, then categorized as 'worsened'.
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Overall Number of Participants Analyzed = participants evaluable for this outcome measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 6: Worsened | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 6: Unchanged | 20 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 6: Improved | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 18: Worsened | 9 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 18: Unchanged | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 18: Improved | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 24: Worsened | 6 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 24: Unchanged | 10 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 24: Improved | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 30: Worsened | 9 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 30: Unchanged | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 30: Improved | 5 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 36: Worsened | 8 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 36: Unchanged | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 36: Improved | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 42: Worsened | 9 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 42: Unchanged | 6 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 42: Improved | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 48: Worsened | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 48: Unchanged | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 48: Improved | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 54: Worsened | 7 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 54: Unchanged | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 54: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 66: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 66: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 66: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 72: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 72: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 72: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 78: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 78: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 78: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 84: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 84: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 84: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 90: Worsened | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 90: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 90: Improved | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 96: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 96: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 96: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 102: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 102: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 102: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 108: Worsened | 4 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 108: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 108: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 114: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 114: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 114: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 120: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 120: Unchanged | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 120: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 132: Worsened | 1 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 132: Unchanged | 0 Participants |
| Tafamidis 20 mg | Number of Participants Categorized on Basis of Change From Baseline in Total Distance Walked During 6 Minute Walk Test (6MWT) at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120 and 132 | Month 132: Improved | 0 Participants |
Secondary
Number of Participants With Abnormalities in Echocardiography
Echocardiography abnormalities included: absent respiratory variation of inferior vena cava, any valve thickening, aortic valve thickening, decreased respiratory variation of inferior vena cava, dilated inferior vena cava, E deceleration time less than or equal to (\<=) 150 millisecond, E wave/A Wave (E/A) ratio \>=2, ejection fraction \< 50%, isovolumic relaxation time (IVRT) \<=70 millisecond, left ventricular posterior wall thickness \>=13 millimeter (mm), left ventricular septal thickness \>= 13 mm, mitral valve thickening, pericardial effusion, pulmonary valve thickening, right ventricular thickness \>=7 mm, tricuspid valve thickening, ratio between early mitral inflow velocity and mitral annular early diastolic velocity (e/e') Lateral greater than (\>) 15, e/e' Septal \>15.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tafamidis 20 mg | Number of Participants With Abnormalities in Echocardiography | 31 Participants |
Secondary
Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events
All cause hospitalization was defined as any serious adverse event, which resulted in hospitalization. Cardiac-related hospitalization was any hospitalization meeting the following criteria: cardiac disorders or AE preferred term as chest discomfort, chest pain, death, cerebrovascular accident, embolic stroke, disease progression.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events | All-cause Hospitalization | 27 Participants |
| Tafamidis 20 mg | Number of Participants With All-cause Hospitalization and Cardiac-related Hospitalization Events | Cardiac Related Hospitalization | 18 Participants |
Secondary
Number of Participants With Any Concomitant Medications
Number of participants who used medication other than study drug were reported.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tafamidis 20 mg | Number of Participants With Any Concomitant Medications | 31 Participants |
Secondary
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
NYHA classified participants in 4 classes: Class I: cardiac disease without limitations of physical activity. Ordinary physical activity caused no undue fatigue, palpitation, dyspnea or angina pain. Class II: cardiac disease with slight limitation of physical activity, comfortable at rest. Ordinary physical activity resulted in fatigue, palpitation, dyspnea or angina pain. Class III: cardiac disease with marked limitation of physical activity, comfortable at rest. Less than ordinary physical activity caused fatigue, palpitation, dyspnea or angina pain. Class IV: cardiac disease with inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or angina syndrome might be present even at rest. If any physical activity was undertaken, discomfort was increased. Participants with change from baseline were classified as improved (shifted from higher to lower class), unchanged (no change in class) or worsened (shifted from lower to higher class).
Time frame: Baseline, Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Worsened | 5 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Unchanged | 25 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Improved | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Worsened | 7 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Unchanged | 17 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Improved | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Worsened | 7 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Unchanged | 12 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Improved | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Worsened | 4 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Unchanged | 14 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Improved | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Worsened | 6 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Unchanged | 11 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Improved | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Worsened | 10 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Unchanged | 5 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Improved | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Worsened | 6 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Unchanged | 4 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Improved | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Worsened | 6 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Unchanged | 6 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Worsened | 5 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Unchanged | 5 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Unchanged | 4 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Unchanged | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Unchanged | 4 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Improved | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Unchanged | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Improved | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Improved | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Worsened | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Unchanged | 2 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Worsened | 3 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Worsened | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Unchanged | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Improved | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Worsened | 1 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Unchanged | 0 Participants |
| Tafamidis 20 mg | Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification at Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Improved | 0 Participants |
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
ECG parameters included PR interval (millisecond), RR interval (millisecond), QRS interval (millisecond), QT and QTc interval (millisecond) and heart rate (beats per minute). Clinical significance of any ECG finding was judged by investigator.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tafamidis 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 1 Participants |
Secondary
Number of Participants With Clinically Significant Physical Examination Findings
Physical examination included examination of general appearance, endocrine, head and neck, cardiovascular, eyes, abdomen, ears, skin, nose, musculoskeletal, throat, neurological, respiratory, immunologic/allergies, genitourinary, hematologic/lymphatic. Clinical significance of any physical examination finding was judged by investigator.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tafamidis 20 mg | Number of Participants With Clinically Significant Physical Examination Findings | 19 Participants |
Secondary
Number of Participants With Laboratory Abnormalities
Laboratory parameters included hematology and biochemistry: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen, gamma glutamyl transferase (GGT), creatinine, total bilirubin, international normalized ratio (INR), troponin I, troponin T, prothrombin time, sodium, globulin potassium, chloride, bicarbonate, cholesterol, calcium, uric acid, inorganic phosphorous, thyroid-stimulating hormone, glucose, total thyroxine (T4), free T4, total proteins, prealbumin (transthyretin), albumin, hemoglobin, platelets, hematocrit, white blood cell count, red blood cell count, neutrophils, packed cell volume, lymphocytes, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, eosinophils, mean corpuscular hemoglobin concentration, basophils, retinol-binding protein, Urinalysis: bilirubin, pH, blood (free Hb), protein, nitrite, glucose, urobilinogen, ketones, specific gravity.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tafamidis 20 mg | Number of Participants With Laboratory Abnormalities | 27 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AEs | 31 Participants |
| Tafamidis 20 mg | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 29 Participants |
Secondary
Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events. Relatedness to study drug was assessed by the investigator as (Yes/No).
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tafamidis 20 mg | Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participant with AEs | 7 Participants |
| Tafamidis 20 mg | Number of Participants With Treatment-Related Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participant with SAEs | 4 Participants |
Secondary
Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132
Participants overall quality of life was measured by PGA. At each follow-up visit, participants were asked, How do you feel today as compared to when we talked with you at your last clinic visit for this study? and participants responded to any of the following: markedly improved, moderately improved, mildly improved, unchanged, mildly worsened, moderately worsened or markedly worsened.
Time frame: Month 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132
Population: ITT population included all participants who were enrolled and received at least 1 dose of study medication, had baseline and at least 1 post-baseline cardiac measure. Number analyzed =participants evaluable for this outcome measure at specified time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Markedly Improved | 9.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Moderately Improved | 3.2 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Mildly Improved | 9.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Unchanged | 51.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Mildly Worsened | 25.8 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 6: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Markedly Improved | 7.1 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Moderately Improved | 10.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Mildly Improved | 17.9 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Unchanged | 25.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Mildly Worsened | 17.9 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Moderately Worsened | 10.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 18: Markedly Worsened | 10.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Markedly Improved | 9.1 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Moderately Improved | 18.2 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Mildly Improved | 13.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Unchanged | 27.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Mildly Worsened | 22.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Moderately Worsened | 4.5 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 24: Markedly Worsened | 4.5 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Moderately Improved | 10.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Mildly Improved | 5.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Unchanged | 40.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Mildly Worsened | 25.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Moderately Worsened | 20.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 30: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Mildly Improved | 5.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Unchanged | 47.4 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Mildly Worsened | 26.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Moderately Worsened | 21.1 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 36: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Unchanged | 29.4 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Mildly Worsened | 35.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Moderately Worsened | 11.8 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 42: Markedly Worsened | 23.5 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Mildly Improved | 23.1 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Unchanged | 53.8 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Mildly Worsened | 15.4 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Moderately Worsened | 7.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 48: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Moderately Improved | 7.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Unchanged | 61.5 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Mildly Worsened | 23.1 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Moderately Worsened | 7.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 54: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Markedly Improved | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Unchanged | 50.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Mildly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Moderately Worsened | 33.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 66: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Unchanged | 71.4 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Mildly Worsened | 28.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 72: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Markedly Improved | 14.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Unchanged | 28.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Mildly Worsened | 28.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Moderately Worsened | 28.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 78: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Markedly Improved | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Unchanged | 33.3 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Mildly Worsened | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Moderately Worsened | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 84: Markedly Worsened | 16.7 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Mildly Improved | 42.9 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Unchanged | 28.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Mildly Worsened | 28.6 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 90: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Unchanged | 25.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Mildly Worsened | 50.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Moderately Worsened | 25.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 96: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Unchanged | 75.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Mildly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 102: Markedly Worsened | 25.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Markedly Improved | 40.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Mildly Improved | 20.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Unchanged | 40.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Mildly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 108: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Mildly Improved | 25.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Unchanged | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Mildly Worsened | 75.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 114: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Mildly Improved | 50.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Unchanged | 50.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Mildly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 120: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Unchanged | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Mildly Worsened | 100.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 126: Markedly Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Markedly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Moderately Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Mildly Improved | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Unchanged | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Mildly Worsened | 100.0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Moderately Worsened | 0 percentage of participants |
| Tafamidis 20 mg | Percentage of Participants With Categories of Patient Global Assessment (PGA) for Follow-up Visit: Months 6, 18, 24, 30, 36, 42, 48, 54, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126 and 132 | Month 132: Markedly Worsened | 0 percentage of participants |
Secondary
Time to All-cause Mortality and Cardiac-Related Mortality
Time to death for all participants with a death date in Clinical Database, or censored at the last dose date + 28 days for those participants who were alive at the end of the study is reported.
Time frame: Post-Month 12 up to Month 132 (approximately 10 years) of Study FX1B-303
Population: Safety analysis population included all participants who were enrolled in this study and who had taken at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tafamidis 20 mg | Time to All-cause Mortality and Cardiac-Related Mortality | All-Cause Mortality | 4.1 years |
| Tafamidis 20 mg | Time to All-cause Mortality and Cardiac-Related Mortality | Cardiac-related mortality | 5.9 years |