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| ID | Type | Description | Link |
|---|---|---|---|
| NCT04108091 | Registry Identifier | ClinicalTrials.gov |
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Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan. This study is conducted in accordance with the protocol even when Vynmac is used, and information the use of Vynmac during the observation period is also collected.
To comprehend information on the long-term safety (e.g., onset status of adverse reactions), etc. of patients who are treated with Vyndaqel for the treatment of transthyretin amyloid cardiomyopathy. When Vynmac is used, conduct the study to grasp information on safety (e.g., onset status of adverse reactions),etc. during the observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for TTR amyloidosis | Transthyretin amyloid cardiomyopathy (wild-type or variants) patients administered Vyndaqel and Vynmac. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment for TTR amyloidosis | Drug | The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | An ADR was any untoward medical occurrence attributed to Vyndaqel capsules 20mg or Vynmac capsules 61mg in a participant who received this drug. A serious ADR was ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Vyndaqel capsules 20mg or Vynmac capsules 61mg was assessed without distinction. | 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died | The proportion of participants who died from any cause and from cardiovascular-related causes during the observation period was assessed. | 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are administered with this drug for the treatment of ATTR-CM
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Tokyo | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vyndaqel Capsules 20mg (Tafamidis Meglumine) and Vynmac Capsules 61mg(Tafamidis) | Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of adverse drug reaction [ADR]), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 1214 participants were enrolled, and case report forms were collected from 1211 participants. Of these, 153 transfer participants identified by registration numbers were consolidated. Another 185 participants were excluded due to the following reasons: no informed consent for publication of study results, protocol violation, no adverse event information (no revisits), or no administration information. The remaining 873 participants were included in the safety analysis set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis) | Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions | An ADR was any untoward medical occurrence attributed to Vyndaqel capsules 20mg or Vynmac capsules 61mg in a participant who received this drug. A serious ADR was ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Vyndaqel capsules 20mg or Vynmac capsules 61mg was assessed without distinction. | The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Vyndaqel capsules 20mg or Vynmac capsules 61mg at least once. Participants with protocol violation, or lacking informed consent for publication of study results, adverse event information (no revisits), or administration information were excluded. | Posted | Count of Participants | Participants | 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation. |
|
30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis) | Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2023 | Mar 11, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2025 | Mar 11, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| C547076 | tafamidis |
Not provided
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|
| Treatment for TTR amyloidosis | Drug | The usual adult dose is 61 mg of tafamidis orally once daily. |
|
|
| NYHA Classification Changes |
Changes in NYHA functional classification at Month 30 compared with baseline were summarized using cross-tabulation and expressed as percentages, with the number of participants in each NYHA class at baseline as the denominator. The NYHA class ranges from Class 1 to 4, with lower class numbers indicating better functional status; Class 1 indicates no limitation of physical activity, whereas Class 4 indicates symptoms at rest. |
| 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation. |
| Protocol Violation |
|
| No administration information |
|
| No adverse event information (No revisits) |
|
| Count of Participants |
| Participants |
|
| Sex: Female, Male | A total of 1,214 participants were enrolled, and case report forms were obtained from 1,211. After consolidating 153 transfer cases and excluding 185 participants with protocol violations, no consent for publication, or no adverse event or administration information, 873 participants were included in the safety analysis set. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Vyndaqel Capsules 20mg (Tafamidis Meglumine)and Vynmac Capsules 61mg(Tafamidis) | Participants who received Vyndaqel capsules 20mg (80 mg once daily) as indicated in the approved local product document were observed for a period of 30 months. The dosage can be adjusted as per physician's discretion, and data were collected prospectively and retrospectively. In this study, Vynmac capsules 61mg was also investigated: when Vynmac capsules 61mg was used during the observation period, observation was also continued until the planned observation period was completed to comprehend information on the safety (e.g., onset status of ADR), etc. of Vynmac capsules 61mg. Safety and effectiveness were evaluated using all data collected during the observation period without classifying the data into Vyndaqel capsules 20mg and Vynmac capsules 61mg. |
|
|
| Secondary | Percentage of Participants Who Died | The proportion of participants who died from any cause and from cardiovascular-related causes during the observation period was assessed. | The efficacy analysis set (EAS) comprised subjects from the SAS, excluding those who were unable to evaluate effectiveness | Posted | Number | percentage of participants | 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation. |
|
|
|
| Secondary | NYHA Classification Changes | Changes in NYHA functional classification at Month 30 compared with baseline were summarized using cross-tabulation and expressed as percentages, with the number of participants in each NYHA class at baseline as the denominator. The NYHA class ranges from Class 1 to 4, with lower class numbers indicating better functional status; Class 1 indicates no limitation of physical activity, whereas Class 4 indicates symptoms at rest. | The efficacy analysis set (EAS) comprised subjects from the SAS, excluding those who were unable to evaluate effectiveness. | Posted | Number | Percentage of Participants | 30 months,Participants who discontinued this drug during the observation period, the observation period was until the first visit after the date of discontinuation. |
|
|
|
| 31 |
| 873 |
| 202 |
| 873 |
| 101 |
| 873 |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Campylobacter infection | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Aspiration pneumonia | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA/J27.1 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J27.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Marasmus | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hepatic coma | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Positional vertigo | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Benign paroxysmal positional vertigo | Ear and labyrinth disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Complete atrioventricular block | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Acute cardiac failure | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac amyloidosis | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac dysfunction | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrial thrombosis | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Low cardiac output syndrome | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Jugular vein distension | Vascular disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Spontaneous pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Haemorrhagic gastric ulcer | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Appendiceal disorder | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Exfoliative dermatitis | Skin and subcutaneous tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hypokinesia | Musculoskeletal and connective tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Immobilisation syndrome | Musculoskeletal and connective tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Ulcer | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Sudden death | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Traumatic subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Epidural haematoma | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Femoral fracture | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Heat stroke | Injury, poisoning and procedural complications | MedDRA/J27.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA/J27.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
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| From baseline Class 1 to Month 30 Class 3 |
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| From baseline Class 1 to Month 30 Class 4 |
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| From baseline Class 1 to not assessed at Month 30 |
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| From baseline Class 2 to Month 30 Class 1 |
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| From baseline Class 2 to Month 30 Class 2 |
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| From baseline Class 2 to Month 30 Class 3 |
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| From baseline Class 2 to Month 30 Class 4 |
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| From baseline Class 2 to not assessed at Month 30 |
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| From baseline Class 3 to Month 30 Class 1 |
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| From baseline Class 3 to Month 30 Class 2 |
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| From baseline Class 3 to Month 30 Class 3 |
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| From baseline Class 3 to Month 30 Class 4 |
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| From baseline Class 3 to not assessed at Month 30 |
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| From baseline Class 4 to Month 30 Class 1 |
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| From baseline Class 4 to Month 30 Class 2 |
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| From baseline Class 4 to Month 30 Class 3 |
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| From baseline Class 4 to Month 30 Class 4 |
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| From baseline Class 4 to not assessed at Month 30 |
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