Amyloidosis
Conditions
Keywords
echocardiography (ECHO), skin biopsy, monoclonal anti-serum amyloid p component antibody (anti-SAP mAb), Amyloidosis, cardiac magnetic resonance imaging (CMR), biomarkers, cardiac functional measures, left ventricular mass
Brief summary
The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and echocardiography (ECHO), and whether this is associated with an improvement in cardiac function. Cohort 1 is transthyretin cardiomyopathy (ATTR-CM) , cohort 2 is patients with immunoglobulin light chain (AL) systemic amyloidosis at greater than 6 months post chemotherapy, cohort 3 newly diagnosed AL systemic amyloidosis undergoing chemotherapy. Primary objectives for the study are assessment of reduction in cardiac amyloid load after repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups and assessment of safety & tolerability of repeated administration of Anti-SAP treatment, including compatibility with chemotherapy treatment in patients with AL systemic amyloidosis. This is an open label, non-randomised, three-group, monthly repeat Anti-SAP treatment study in systemic amyloidosis patients with cardiac dysfunction caused by cardiac amyloidosis. Subjects will receive up to 6 courses of Anti-SAP treatment. Maximum total duration for a subject in the study is approximately 18 months.
Interventions
20mg/hour, IV (in the vein) for up to 72hours followed by 60mg three times daily subcutaneous injection for 11 days. Number of cycles: up to 6. Dose level and frequency adjusted according to renal function
BIOLOGICALGSK2398852 (anti-SAP mAb)
Up to 1200mg, IV divided over days 1 and 3. Number of cycles: up to 6. Dose level adjusted based on tolerability.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 80 years of age inclusive, at the time of signing the informed consent. * Male and female. Males: Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication for a cycle of spermatogenesis following five terminal half-lives after the last dose of study medication. Vasectomy with documentation of azoospermia. Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined Oral Contraceptive or Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches . This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. Females A female subject is eligible to participate if she is not pregnant (as confirmed by a negative Urine human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy. Postmenopausal defined as: 60 years old; Twelve(12) months of spontaneous amenorrhea with an appropriate clinical profile, e.g. age appropriate, \> 45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g. leuprolide treatment) in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (As mentioned in study protocol) from 30 days prior to the first dose of study medication and until 3 months after the last dose of study medication. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form * Late-Gadolinum enhancement (LGE) on CMR indicative of cardiac amyloidosis * LV mass on CMR \> 200 grams (g) Inclusion Criteria for Group 1 * Transthyretin amyloid (ATTR) cardiomyopathy (CM) * Subjects with a diagnosis of hereditary ATTR amyloidosis should have a known amyloidogenic transthyretin (TTR) mutation demonstrated by genotyping AND is recognised to be primarily associated with cardiomyopathy AND one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. Or Scintigraphy: 99m\^Tc-DPD with Grade 2 cardiac uptake or 99m\^Tc-PYP with either Grade 2 or 3 cardiac uptake. * Subjects with a diagnosis of wild type ATTR-CM must be negative by genotyping and have one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR Scintigraphy 99m\^Technetium-dicarboxypropane diphosphonate (99m\^Tc-DPD) with Grade 2 cardiac uptake or 99m\^ Technetium-pyrophosphate (99m\^Tc-PYP) with Grade 2 or 3 cardiac uptake. * Clinically stable in New York heart association (NYHA) class 2 or 3 for the 3 months preceding screening Inclusion Criteria for Group 2 * Subject medically diagnosed with AL amyloidosis that has required chemotherapy or an autologous stem cell transplant based upon: AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type, in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded * Clinically stable in NYHA class 2 or 3 for the 3 months preceding screening * \>=6 months after completing any line of chemotherapy, or after autologous stem cell transplantation, and having attained either a very good partial response (VGPR) or a complete response (CR), and without the need for haematological maintenance therapies Inclusion Criteria for Group 3 * Newly diagnosed AL amyloidosis based upon: AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded * Mayo stage II or IIIa * Confirmed free light chain complete response (CR) during the first three cycles of first-line chemotherapy where at least the first cycle has been with cyclophosphamide, bortezomib, dexamethasone (CyBorD).
Exclusion criteria
* Cardiomyopathy primarily caused by non-amyloid diseases (e.g. ischemic heart disease; valvular heart disease) * Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) \> 500 millisecond (msec) * Sustained / symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at screening * Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening. Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at screening * N-terminal pro b-type Natriuretic Peptide \[(NT)-proBNP\] \>8500 nanograms (ng)/ Liter (L) * Glomerular filtration rate (GFR) at Screening \< 40 milliliter (mL)/minute (min) * Any active and persistent dermatological condition * Existing diagnosis of any type of dementia * History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation, during the course of the study. * Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated. * Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting \[CABG\]), within 6 months of screening. * Stroke within 6 months of screening, or transient ischaemic attack (TIA) within 3 months of screening * Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment * Hypoalbuminaemia (serum albumin \< 30 g/L) * Uncontrolled hypertension during screening * Alanine transaminase ALT \>3x upper limit of normal (ULN) AND bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * Peripheral oedema at Screening that in the opinion of the Prinicpal Investigator (PI) or designee might prevent adequate absorption of subcutaneously administered CPHPC * Urine dipstick positive (\>1+) for blood during screening with investigation indicating glomerular haematuria. If other causes are identified, subjects may be enrolled on resolution of the abnormality * Presence of any co-morbid or an uncontrolled medical condition (e.g. diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a patient * Positive test for hepatitis B hepatitis C, and / or human immunodeficiency virus (HIV) during screening, or within 3 months prior to first dose of study treatment * Unwillingness or inability to follow the procedures outlined in the protocol * Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening * Any prohibited concomitant medication as per protocol within 28 days of Screening * Donation of blood or blood products in excess of 500 mL within 84 days of screening * Lactating females * Poor or unsuitable venous access * Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer. * History of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation CARDIAC MAGNETIC RESONANCE (CMR) SCANNING * Orthopnoea of sufficient severity to preclude supine scanning as determined at screening * Contraindication to magnetic resonance imaging (MRI) contrast agents * Inability to fit inside scanner due to body size (girth) * Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: * Intracranial aneurysm clips (except Sugita) or other metallic objects * Intra- orbital metal fragments that have not been removed * Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-MR conditional heart valves * Inner ear implants * History of claustrophobia 99m\^TC-PYP OR 99mTC-DPD BONE TRACER RADIOSCINTOGRAPHY * Orthopnoea of sufficient severity to preclude supine scanning as determined at Screening * Previous allergic reaction to radioisotope bone tracers * Previous inclusion in a research protocol involving nuclear medicine, positron emission tomography (PET) or radiological investigations with significant radiation burden (a significant radiation burden being defined as 10 mSv in addition to natural background radiation, in the previous 3 years).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up | Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]). |
| Number of Participants With Any On-treatment Adverse Events (AEs) | Up to 56 days after the last dosing session (up to 265 days) | AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented. |
| Number of Participants With Any Serious Adverse Events (SAEs) | Up to the end of study (Up to 369 days) | AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented. |
| Number of Participants With Abnormal Hematology Values | Up to the end of study (Up to 369 days) | Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories. |
| Number of Participants With Abnormal Clinical Chemistry Values | Up to the end of study (Up to 369 days) | Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories. |
| Number of Participants With Abnormal Urinalysis Results | Up to the end of study (Up to 369 days) | Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories. |
| Number of Participants With Abnormal Urinalysis Results for Character Parameters | Up to the end of study (Up to 369 days) | Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented. |
| Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | Up to the end of study (Up to 369 days) | Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: \>37.5 degree Celsius; low: not applicable. |
| Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: \>180 millimeter of mercury (mmHg); low: \<90 mmHg. PCI criteria for DBP was: high: \>110 mmHg; low: \<30 mmHg. |
| Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | Up to the end of study (Up to 369 days) | Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: \>140 beats per minute (bpm); low: \<35 bpm. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to the end of study (Up to 369 days) | Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant. |
| Number of Participants With Abnormalities During Cardiac Monitoring | Up to the end of study (Up to 369 days) | Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant. |
| Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons | Up to the end of study (Up to 369 days) | Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented. |
| Number of Participants With Skin Rashes | Up to 56 days after the last dosing session (up to 265 days) | Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented. |
| Number of Participants With Skin Rashes Classified Using CTCAE | Up to 56 days after the last dosing session (up to 265 days) | Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Global Longitudinal Strain (GLS) by CMR | Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up | Global Longitudinal Strain was measured by CMR at indicated time points. GLS included feature tracking and tagging by CMR. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in GLS by ECHO | Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up | Global Longitudinal Strain was measured by ECHO at indicated time points. GLS included speckle tracking by ECHO. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in LV Twist Over Time | Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up | LV twist was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Stroke Volume (SV) by CMR | Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up | Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in SV by ECHO | Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up | Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies | Up to the end of study (Up to 369 days) | Skin biopsy samples were collected for histopathological examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented. |
| Change From Baseline in Left Ventricular EF by ECHO | Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up | Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up | Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up | Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up | E/e' ratio was measured by ECHO at indicated time points. It had 2 separate measurements: lateral and septal. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up | Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies | Up to the end of study (Up to 369 days) | Skin biopsy samples were collected for immunohistochemical examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented. |
| Number of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers | Up to the end of study (Up to 369 days) | Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. |
| Number of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers | Up to the end of study (Up to 369 days) | Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. |
| Change From Baseline in Plasma Cytokines Over Time | Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5 | Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ. |
| Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6 | Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 3 (C3). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | Baseline (Day -1) and Day 2, Day 5, Day 6 | Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 4 (C4). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6 | Blood samples were collected for assessment of Fluid Phase Complement Markers which included total complement (CH50). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Inflammatory Biomarkers Over Time | Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6 | Blood samples were collected for assessment of inflammatory biomarkers which included C-Reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum amyloid A protein (SAA). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. |
| Maximum Concentration (Cmax) of GSK2398852 | Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11 | Blood samples were collected for evaluation of Pharmacokinetic (PK) parameters including Cmax at indicated time points. Geometric mean and geometric coefficient of variation of Cmax is presented. |
| Time Associated With Cmax (Tmax) of GSK2398852 | Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11 | Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented. |
| Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11 | Blood samples were collected for evaluation of PK parameters including AUC 0-t at indicated time points. Geometric mean and geometric coefficient of variation of AUC0-t is presented. |
| Cmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants | Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days) | Blood samples were planned to be collected for evaluation of PK parameters including Cmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants.' |
| Tmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants | Day 1: Pre-dose; Day 2: pre-dose and 2 hours post-dose; Day 3: Pre-dose in each session (each session of 24 days) | Blood samples were planned to be collected for evaluation of PK parameters including Tmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'. |
| AUC 0-t of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants | Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days) | Blood samples were planned to be collected for evaluation of PK parameters including AUC0-t at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
This was an open label, non-randomized, monthly repeat anti-serum amyloid p component (anti-SAP) treatment study in systemic amyloidosis participants with cardiac dysfunction caused by cardiac amyloidosis.
Pre-assignment details
Twelve participants were screened; seven were enrolled in to study (six were enrolled in Group 1 and one in Group 2). No participant was enrolled in Group 3. The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-SAP treatment).
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb. | 6 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb. | 1 |
| Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb. | 0 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Group 2: Post-chemotherapy AL Amyloidosis Participants | Total | Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants |
|---|---|---|---|---|
| Age, Continuous | 74.3 Years STANDARD_DEVIATION 3.27 | 67.0 Years | 73.3 Years STANDARD_DEVIATION 4.07 | — |
| Race/Ethnicity, Customized Race White/Caucasian/European Heritage | 6 Participants | 1 Participants | 7 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 1 |
| other Total, other adverse events | 6 / 6 | 1 / 1 |
| serious Total, serious adverse events | 2 / 6 | 1 / 1 |
Outcome results
Primary
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]).
Time frame: Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Session 2, Day 24, n=6,0 | 2.505 Grams | Standard Deviation 19.9174 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Session 3, Day 24, n=6,0 | 4.175 Grams | Standard Deviation 22.9366 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Session 4, Day 24, n=5,0 | 9.194 Grams | Standard Deviation 14.4271 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | Session 5, Day 24, n=4,0 | 7.955 Grams | Standard Deviation 19.4341 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | 8 Weeks Follow up, n=6,1 | 0.977 Grams | Standard Deviation 12.1795 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up | 8 Weeks Follow up, n=6,1 | -32.420 Grams | — |
Primary
Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons
Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population. Only those participants with data available at the specified time point was analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons | 2 Participants |
Primary
Number of Participants With Abnormal Clinical Chemistry Values
Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Chloride, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | AST, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Chloride, normal | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Albumin, normal | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Chloride, low | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Direct Bilirubin, high | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | CO2, high | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALP, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | CO2, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Direct Bilirubin, normal | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | CO2, low | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Glucose, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine, high | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Direct Bilirubin, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine, normal | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALT, high | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Total Bilirubin, high | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Potassium, high | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Albumin, low | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Potassium, normal | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Total Bilirubin, normal | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Potassium, low | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALT, normal | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | LDH, high | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Total Bilirubin, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | LDH, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Albumin, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | LDH, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Calcium, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Protein, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALT, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Protein, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Calcium, normal | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Protein, low | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALP, high | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Sodium, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Calcium, low | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Sodium, normal | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | AST, high | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Sodium, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine Kinase, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urate, high | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Glucose, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urate, normal | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine Kinase, normal | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urate, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | AST, normal | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urea, high | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine Kinase, low | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urea, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALP, normal | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urea, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Clinical Chemistry Values | Glucose, high | 6 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urea, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Glucose, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Glucose, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Glucose, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Albumin, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Albumin, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Albumin, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALP, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALP, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALP, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALT, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALT, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | ALT, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | AST, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | AST, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | AST, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Direct Bilirubin, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Direct Bilirubin, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Direct Bilirubin, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Total Bilirubin, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Total Bilirubin, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Total Bilirubin, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Calcium, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Calcium, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Calcium, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine Kinase, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine Kinase, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine Kinase, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Chloride, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Chloride, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Chloride, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | CO2, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | CO2, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | CO2, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Creatinine, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Potassium, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Potassium, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Potassium, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | LDH, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | LDH, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | LDH, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Protein, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Protein, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Protein, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Sodium, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Sodium, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Sodium, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urate, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urate, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urate, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urea, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Clinical Chemistry Values | Urea, normal | 0 Participants |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Clinically significant | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Not Clinically significant | 6 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Clinically significant | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Abnormal-Not Clinically significant | 1 Participants |
Primary
Number of Participants With Abnormal Hematology Values
Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Hemoglobin, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Eosinophils, high | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Basophils, high | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Basophils, normal | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Basophils, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Eosinophils, normal | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Eosinophils, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Hematocrit, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Hematocrit, normal | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Hematocrit, low | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Hemoglobin, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Hemoglobin, low | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Lymphocytes, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Lymphocytes, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Lymphocytes, low | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCH, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCH, normal | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCH, low | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCHC, high | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCHC, normal | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCHC, low | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCV, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCV, normal | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | MCV, low | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Monocytes, high | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Monocytes, normal | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Monocytes, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Neutrophils, high | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Neutrophils, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Neutrophils, low | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Platelet count, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Platelet count, normal | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Platelet count, low | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Erythrocytes, high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Erythrocytes, normal | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Erythrocytes, low | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Reticulocytes, high | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Reticulocytes, normal | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Reticulocytes, low | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Leukocytes, high | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Leukocytes, normal | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Hematology Values | Leukocytes, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Platelet count, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCHC, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Monocytes, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Reticulocytes, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Basophils, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCV, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Basophils, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Leukocytes, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Basophils, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Eosinophils, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCV, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Eosinophils, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Platelet count, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Eosinophils, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCV, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Hematocrit, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Reticulocytes, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Hematocrit, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Monocytes, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Hematocrit, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Platelet count, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Hemoglobin, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Erythrocytes, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Hemoglobin, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Monocytes, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Hemoglobin, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Leukocytes, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Lymphocytes, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Erythrocytes, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Lymphocytes, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Neutrophils, high | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Lymphocytes, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Reticulocytes, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCH, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Neutrophils, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCH, normal | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Erythrocytes, low | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCH, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Neutrophils, low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCHC, high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | Leukocytes, normal | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Hematology Values | MCHC, normal | 1 Participants |
Primary
Number of Participants With Abnormalities During Cardiac Monitoring
Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population. Only those participants with data available at the specified time point was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormalities During Cardiac Monitoring | Abnormal-Clinically significant | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormalities During Cardiac Monitoring | Abnormal-Not Clinically significant | 3 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormalities During Cardiac Monitoring | Abnormal-Clinically significant | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormalities During Cardiac Monitoring | Abnormal-Not Clinically significant | 1 Participants |
Primary
Number of Participants With Abnormal Urinalysis Results
Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Creatinine excretion rate, high, n=6,1 | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | pH, normal, n=6,1 | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Creatinine excretion rate, normal, n=6,1 | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Specific gravity, high, n=1,0 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Creatinine excretion rate, low, n=6,1 | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Specific gravity, normal, n=1,0 | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Protein excretion rate, high, n=6,1 | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Specific gravity, low, n=1,0 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Protein excretion rate, normal, n=6,1 | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Albumin excretion rate, high, n=6,1 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Protein excretion rate, low, n=6,1 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | pH, high, n=6,1 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Albumin excretion rate, normal, n=6,1 | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | pH, low, n=6,1 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results | Albumin excretion rate, low, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Protein excretion rate, low, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | pH, high, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | pH, normal, n=6,1 | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | pH, low, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Albumin excretion rate, high, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Albumin excretion rate, normal, n=6,1 | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Creatinine excretion rate, high, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Creatinine excretion rate, normal, n=6,1 | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Creatinine excretion rate, low, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Protein excretion rate, high, n=6,1 | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Protein excretion rate, normal, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results | Albumin excretion rate, low, n=6,1 | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Results for Character Parameters
Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Erythrocytes , n=6,1 | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Ketones, n=6,1 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Cellular casts, n=5,1 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Leukocytes, n=6,1 | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Glucose, n=6,1 | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Occult blood, n=6,1 | 2 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Glucose, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Cellular casts, n=5,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Erythrocytes , n=6,1 | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Occult blood, n=6,1 | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Ketones, n=6,1 | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormal Urinalysis Results for Character Parameters | Leukocytes, n=6,1 | 1 Participants |
Primary
Number of Participants With Any On-treatment Adverse Events (AEs)
AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented.
Time frame: Up to 56 days after the last dosing session (up to 265 days)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Any On-treatment Adverse Events (AEs) | 6 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Any On-treatment Adverse Events (AEs) | 1 Participants |
Primary
Number of Participants With Any Serious Adverse Events (SAEs)
AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Any Serious Adverse Events (SAEs) | 2 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Any Serious Adverse Events (SAEs) | 1 Participants |
Primary
Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria
Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: \>37.5 degree Celsius; low: not applicable.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | To high | 2 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | To normal/No change | 4 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | To low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | To high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | To normal/No change | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria | To low | 0 Participants |
Primary
Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria
Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: \>140 beats per minute (bpm); low: \<35 bpm.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | To high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | To normal/No change | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | To low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | To high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | To normal/No change | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria | To low | 0 Participants |
Primary
Number of Participants With Skin Rashes
Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented.
Time frame: Up to 56 days after the last dosing session (up to 265 days)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Skin Rashes | 4 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Skin Rashes | 0 Participants |
Primary
Number of Participants With Skin Rashes Classified Using CTCAE
Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.
Time frame: Up to 56 days after the last dosing session (up to 265 days)
Population: Safety Population. Only those participants with data available at the specified time point was analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Skin Rashes Classified Using CTCAE | Grade 1 | 3 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Skin Rashes Classified Using CTCAE | Grade 2 | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Skin Rashes Classified Using CTCAE | Grade 3 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Skin Rashes Classified Using CTCAE | Grade 4 | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Skin Rashes Classified Using CTCAE | Grade 5 | 0 Participants |
Primary
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: \>180 millimeter of mercury (mmHg); low: \<90 mmHg. PCI criteria for DBP was: high: \>110 mmHg; low: \<30 mmHg.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | SBP, To high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | SBP, To normal/No change | 1 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | SBP, To low | 5 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | DBP, To high | 0 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | DBP, To normal/No change | 6 Participants |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | DBP, To low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | DBP, To normal/No change | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | SBP, To high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | DBP, To high | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | SBP, To normal/No change | 1 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | DBP, To low | 0 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria | SBP, To low | 0 Participants |
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Blood samples were collected for evaluation of PK parameters including AUC 0-t at indicated time points. Geometric mean and geometric coefficient of variation of AUC0-t is presented.
Time frame: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 3, n=6,0 | 13804.6 Hour*micrograms per milliliter (h*ug/mL) | Geometric Coefficient of Variation 50.34 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 6, n=4,0 | 17126.7 Hour*micrograms per milliliter (h*ug/mL) | Geometric Coefficient of Variation 43.98 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 2, n=6,0 | 14610.1 Hour*micrograms per milliliter (h*ug/mL) | Geometric Coefficient of Variation 34.73 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 1, n=6,1 | 5130.0 Hour*micrograms per milliliter (h*ug/mL) | Geometric Coefficient of Variation 46.72 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 4, n=5,0 | 12970.9 Hour*micrograms per milliliter (h*ug/mL) | Geometric Coefficient of Variation 51.52 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 5, n=4,0 | 15595.3 Hour*micrograms per milliliter (h*ug/mL) | Geometric Coefficient of Variation 51.13 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852 | Session 1, n=6,1 | 2148.2 Hour*micrograms per milliliter (h*ug/mL) | — |
Secondary
AUC 0-t of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants
Blood samples were planned to be collected for evaluation of PK parameters including AUC0-t at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Time frame: Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)
Population: Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Secondary
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 3 (C3). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 1, 4 hour, n=4,0 | -0.145 Grams per Liter (g/L) | Standard Deviation 0.2528 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 3, predose, n=6,1 | -0.198 Grams per Liter (g/L) | Standard Deviation 0.1607 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 3, 8 hour, n=4,0 | -0.235 Grams per Liter (g/L) | Standard Deviation 0.2301 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 5, n=4,0 | -0.258 Grams per Liter (g/L) | Standard Deviation 0.2035 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 6, n=4,0 | -0.288 Grams per Liter (g/L) | Standard Deviation 0.1941 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 1, predose, n=4,0 | -0.152 Grams per Liter (g/L) | Standard Deviation 0.2144 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 1, 2 hour, n=4,0 | -0.145 Grams per Liter (g/L) | Standard Deviation 0.1877 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 1, 4 hour, n=4,0 | -0.125 Grams per Liter (g/L) | Standard Deviation 0.1741 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 3, 2 hour, n=6,0 | -0.188 Grams per Liter (g/L) | Standard Deviation 0.1572 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 3, 4 hour, n=6,0 | -0.222 Grams per Liter (g/L) | Standard Deviation 0.1288 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 3, 8 hour, n=6,0 | -0.155 Grams per Liter (g/L) | Standard Deviation 0.159 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 5, n=6,0 | -0.280 Grams per Liter (g/L) | Standard Deviation 0.1646 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 6, n=6,0 | -0.338 Grams per Liter (g/L) | Standard Deviation 0.1969 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 1, predose, n=6,0 | -0.067 Grams per Liter (g/L) | Standard Deviation 0.1999 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 1, 2 hour, n=6,0 | -0.103 Grams per Liter (g/L) | Standard Deviation 0.1629 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 1, 4 hour, n=6,0 | -0.075 Grams per Liter (g/L) | Standard Deviation 0.2017 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 1, 8 hour, n=6,0 | -0.130 Grams per Liter (g/L) | Standard Deviation 0.1585 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 2, n=6,0 | -0.153 Grams per Liter (g/L) | Standard Deviation 0.1485 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 3, predose, n=6,0 | -0.263 Grams per Liter (g/L) | Standard Deviation 0.1385 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 3, 2 hour, n=6,0 | -0.242 Grams per Liter (g/L) | Standard Deviation 0.1694 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 3, 4 hour, n=6,0 | -0.243 Grams per Liter (g/L) | Standard Deviation 0.1994 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 3, 8 hour, n=6,0 | -0.235 Grams per Liter (g/L) | Standard Deviation 0.1685 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 5, n=6,0 | -0.280 Grams per Liter (g/L) | Standard Deviation 0.1716 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 2, Day 6, n=6,0 | -0.327 Grams per Liter (g/L) | Standard Deviation 0.2298 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 1, predose, n=6,0 | -0.053 Grams per Liter (g/L) | Standard Deviation 0.1928 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 1, 2 hour, n=6,0 | -0.078 Grams per Liter (g/L) | Standard Deviation 0.2279 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 1, 4 hour, n=6,0 | -0.058 Grams per Liter (g/L) | Standard Deviation 0.2299 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 1, 8 hour, n=6,0 | -0.057 Grams per Liter (g/L) | Standard Deviation 0.1999 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 2, n=5,0 | -0.084 Grams per Liter (g/L) | Standard Deviation 0.2792 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 3, predose, n=6,0 | -0.215 Grams per Liter (g/L) | Standard Deviation 0.1576 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 3, 2 hour, n=6,0 | -0.232 Grams per Liter (g/L) | Standard Deviation 0.1699 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 3, 4 hour, n=6,0 | -0.200 Grams per Liter (g/L) | Standard Deviation 0.1808 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 3, 8 hour, n=6,0 | -0.190 Grams per Liter (g/L) | Standard Deviation 0.2287 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 5, n=6,0 | -0.290 Grams per Liter (g/L) | Standard Deviation 0.1719 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 3, Day 6, n=6,0 | -0.308 Grams per Liter (g/L) | Standard Deviation 0.2077 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 1, predose, n=5,0 | -0.094 Grams per Liter (g/L) | Standard Deviation 0.2271 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 1, 2 hour, n=5,0 | -0.088 Grams per Liter (g/L) | Standard Deviation 0.1993 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 1, 4 hour, n=4,0 | -0.005 Grams per Liter (g/L) | Standard Deviation 0.1392 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 1, 8 hour, n=5,0 | -0.124 Grams per Liter (g/L) | Standard Deviation 0.1747 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 2, n=5,0 | -0.144 Grams per Liter (g/L) | Standard Deviation 0.1641 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 1, 8 hour, n=4,0 | -0.135 Grams per Liter (g/L) | Standard Deviation 0.2626 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 2, n=4,0 | -0.203 Grams per Liter (g/L) | Standard Deviation 0.209 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 3, predose, n=4,0 | -0.215 Grams per Liter (g/L) | Standard Deviation 0.2319 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 3, predose, n=5,0 | -0.214 Grams per Liter (g/L) | Standard Deviation 0.2454 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 3, 2 hour, n=4,0 | -0.273 Grams per Liter (g/L) | Standard Deviation 0.2179 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 3, 2 hour, n=5,0 | -0.204 Grams per Liter (g/L) | Standard Deviation 0.2306 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 3, 4 hour, n=5,0 | -0.190 Grams per Liter (g/L) | Standard Deviation 0.2088 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 3, 4 hour, n=4,0 | -0.235 Grams per Liter (g/L) | Standard Deviation 0.2243 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 3, 8 hour, n=5,0 | -0.188 Grams per Liter (g/L) | Standard Deviation 0.2305 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 5, n=5,0 | -0.270 Grams per Liter (g/L) | Standard Deviation 0.1996 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 3, 8 hour, n=4,0 | -0.238 Grams per Liter (g/L) | Standard Deviation 0.2421 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 5, n=4,0 | -0.288 Grams per Liter (g/L) | Standard Deviation 0.2269 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 6, Day 6, n=4,0 | -0.315 Grams per Liter (g/L) | Standard Deviation 0.2225 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 4, Day 6, n=5,0 | -0.302 Grams per Liter (g/L) | Standard Deviation 0.2251 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 1, predose, n=4,0 | -0.173 Grams per Liter (g/L) | Standard Deviation 0.1863 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, predose, n=6,1 | -0.032 Grams per Liter (g/L) | Standard Deviation 0.1444 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, 2 hour, n=6,1 | -0.008 Grams per Liter (g/L) | Standard Deviation 0.1105 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, 4 hour, n=6,1 | 0.030 Grams per Liter (g/L) | Standard Deviation 0.0566 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, 8 hour, n=6,1 | 0.068 Grams per Liter (g/L) | Standard Deviation 0.2073 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 1, 2 hour, n=4,0 | -0.147 Grams per Liter (g/L) | Standard Deviation 0.2326 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 2, n=6,1 | -0.125 Grams per Liter (g/L) | Standard Deviation 0.1033 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 1, 8 hour, n=4,0 | -0.150 Grams per Liter (g/L) | Standard Deviation 0.1881 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 2, n=4,0 | -0.178 Grams per Liter (g/L) | Standard Deviation 0.234 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 3, predose, n=4,0 | -0.248 Grams per Liter (g/L) | Standard Deviation 0.1919 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 3, 2 hour, n=4,0 | -0.235 Grams per Liter (g/L) | Standard Deviation 0.1964 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 5, Day 3, 4 hour, n=4,0 | -0.280 Grams per Liter (g/L) | Standard Deviation 0.2045 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 3, predose, n=6,1 | -0.200 Grams per Liter (g/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, 2 hour, n=6,1 | -0.230 Grams per Liter (g/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, 8 hour, n=6,1 | -0.160 Grams per Liter (g/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, 4 hour, n=6,1 | -0.100 Grams per Liter (g/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 1, predose, n=6,1 | -0.150 Grams per Liter (g/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time | C3, Session 1, Day 2, n=6,1 | -0.180 Grams per Liter (g/L) | — |
Secondary
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 4 (C4). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Day 2, Day 5, Day 6
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 6, Day 6, n=4,0 | -0.045 Grams per Liter (g/L) | Standard Deviation 0.0666 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 1, Day 2, n=6,1 | -0.015 Grams per Liter (g/L) | Standard Deviation 0.0373 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 5, Day 5, n=4,0 | -0.033 Grams per Liter (g/L) | Standard Deviation 0.0574 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 1, Day 5, n=6,0 | -0.013 Grams per Liter (g/L) | Standard Deviation 0.0393 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 1, Day 6, n=6,0 | -0.017 Grams per Liter (g/L) | Standard Deviation 0.0403 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 2, Day 2, n=6,0 | -0.027 Grams per Liter (g/L) | Standard Deviation 0.0423 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 2, Day 5, n=6,0 | -0.023 Grams per Liter (g/L) | Standard Deviation 0.0505 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 2, Day 6, n=6,0 | -0.030 Grams per Liter (g/L) | Standard Deviation 0.054 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 3, Day 2, n=5,0 | -0.010 Grams per Liter (g/L) | Standard Deviation 0.0543 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 3, Day 5, n=6,0 | -0.042 Grams per Liter (g/L) | Standard Deviation 0.0449 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 3, Day 6, n=6,0 | -0.042 Grams per Liter (g/L) | Standard Deviation 0.0542 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 4, Day 2, n=5,0 | -0.022 Grams per Liter (g/L) | Standard Deviation 0.0531 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 4, Day 5, n=5,0 | -0.036 Grams per Liter (g/L) | Standard Deviation 0.0677 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 4, Day 6, n=5,0 | -0.042 Grams per Liter (g/L) | Standard Deviation 0.0507 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 5, Day 2, n=4,0 | -0.028 Grams per Liter (g/L) | Standard Deviation 0.0574 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 5, Day 6, n=4,0 | -0.025 Grams per Liter (g/L) | Standard Deviation 0.0545 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 6, Day 2, n=4,0 | -0.043 Grams per Liter (g/L) | Standard Deviation 0.0544 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 6, Day 5, n=4,0 | -0.050 Grams per Liter (g/L) | Standard Deviation 0.0678 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time | C4, Session 1, Day 2, n=6,1 | 0.000 Grams per Liter (g/L) | — |
Secondary
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
Blood samples were collected for assessment of Fluid Phase Complement Markers which included total complement (CH50). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 6, n=4,0 | -5.5 Units per milliliter | Standard Deviation 9.47 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 1, 8 hour, n=4,0 | -3.5 Units per milliliter | Standard Deviation 6.66 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 3, predose, n=4,0 | -5.0 Units per milliliter | Standard Deviation 8.52 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 3, 4 hour, n=4,0 | -4.3 Units per milliliter | Standard Deviation 8.66 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 3, 8 hour, n=4,0 | -5.0 Units per milliliter | Standard Deviation 8.52 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 5, n=4,0 | -5.3 Units per milliliter | Standard Deviation 9 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, 4 hour, n=6,1 | 0.2 Units per milliliter | Standard Deviation 0.41 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 3, 2 hour, n=6,0 | -3.3 Units per milliliter | Standard Deviation 4.37 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 6, n=4,0 | -5.3 Units per milliliter | Standard Deviation 8.54 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 2, n=4,0 | -4.3 Units per milliliter | Standard Deviation 6.13 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, predose, n=6,1 | -0.7 Units per milliliter | Standard Deviation 1.37 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, 2 hour, n=6,1 | -0.8 Units per milliliter | Standard Deviation 1.33 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, 8 hour, n=6,1 | -0.8 Units per milliliter | Standard Deviation 1.6 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 2, n=6,1 | -2.7 Units per milliliter | Standard Deviation 3.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 3, predose, n=6,1 | -3.3 Units per milliliter | Standard Deviation 4.46 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 3, 4 hour, n=6,0 | -2.5 Units per milliliter | Standard Deviation 3.78 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 3, 8 hour, n=6,0 | -2.2 Units per milliliter | Standard Deviation 3.25 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 5, n=6,0 | -4.7 Units per milliliter | Standard Deviation 5.01 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 6, n=6,0 | -7.3 Units per milliliter | Standard Deviation 6.19 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 1, predose, n=6,0 | -1.7 Units per milliliter | Standard Deviation 3.67 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 1, 2 hour, n=6,0 | -2.3 Units per milliliter | Standard Deviation 4.84 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 1, 4 hour, n=6,0 | -2.3 Units per milliliter | Standard Deviation 4.63 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 1, 8 hour, n=6,0 | -3.5 Units per milliliter | Standard Deviation 7.84 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 2, n=6,0 | -4.3 Units per milliliter | Standard Deviation 6.02 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 3, predose, n=6,0 | -4.5 Units per milliliter | Standard Deviation 6.16 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 3, 2 hour, n=6,0 | -4.0 Units per milliliter | Standard Deviation 5.55 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 3, 4 hour, n=6,0 | -3.8 Units per milliliter | Standard Deviation 6.31 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 3, 8 hour, n=6,0 | -3.8 Units per milliliter | Standard Deviation 3.92 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 5, n=6,0 | -5.2 Units per milliliter | Standard Deviation 6.31 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 2, Day 6, n=6,0 | -8.5 Units per milliliter | Standard Deviation 9.61 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 1, predose, n=6,0 | -4.5 Units per milliliter | Standard Deviation 7.94 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 1, 2 hour, n=6,0 | -4.2 Units per milliliter | Standard Deviation 7.44 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 1, 4 hour, n=6,0 | -4.5 Units per milliliter | Standard Deviation 7.79 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 1, 8 hour, n=6,0 | -4.8 Units per milliliter | Standard Deviation 8.35 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 2, n=5,0 | -3.6 Units per milliliter | Standard Deviation 8.68 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 3, predose, n=6,0 | -5.2 Units per milliliter | Standard Deviation 8.86 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 3, 2 hour, n=6,0 | -5.2 Units per milliliter | Standard Deviation 8.86 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 3, 4 hour, n=6,0 | -5.3 Units per milliliter | Standard Deviation 8.57 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 3, 8 hour, n=6,0 | -6.8 Units per milliliter | Standard Deviation 10.05 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 5, n=6,0 | -7.0 Units per milliliter | Standard Deviation 10.28 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 3, Day 6, n=6,0 | -8.2 Units per milliliter | Standard Deviation 11.02 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 1, predose, n=5,0 | -3.0 Units per milliliter | Standard Deviation 5.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 1, 2 hour, n=5,0 | -2.0 Units per milliliter | Standard Deviation 3.94 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 1, 4 hour, n=5,0 | -1.6 Units per milliliter | Standard Deviation 4.77 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 1, 8 hour, n=5,0 | -1.6 Units per milliliter | Standard Deviation 3.21 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 2, n=5,0 | -1.6 Units per milliliter | Standard Deviation 3.13 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 3, predose, n=5,0 | -5.0 Units per milliliter | Standard Deviation 6.08 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 3, 2 hour, n=5,0 | -3.2 Units per milliliter | Standard Deviation 4.09 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 3, 4 hour, n=5,0 | -3.0 Units per milliliter | Standard Deviation 6.4 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 3, 8 hour, n=5,0 | -4.0 Units per milliliter | Standard Deviation 6.04 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 5, n=5,0 | -5.6 Units per milliliter | Standard Deviation 7.7 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 4, Day 6, n=5,0 | -6.6 Units per milliliter | Standard Deviation 7.83 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 1, predose, n=4,0 | -3.8 Units per milliliter | Standard Deviation 5.91 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 1, 2 hour, n=4,0 | -3.0 Units per milliliter | Standard Deviation 5.72 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 1, 4 hour, n=4,0 | -2.8 Units per milliliter | Standard Deviation 6.29 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 1, 8 hour, n=4,0 | -3.0 Units per milliliter | Standard Deviation 5.29 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 2, n=4,0 | -3.5 Units per milliliter | Standard Deviation 5.32 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 3, predose, n=4,0 | -5.0 Units per milliliter | Standard Deviation 5.77 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 3, 2 hour, n=4,0 | -4.8 Units per milliliter | Standard Deviation 6.8 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 3, 4 hour, n=4,0 | -4.8 Units per milliliter | Standard Deviation 6.7 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 3, 8 hour, n=4,0 | -4.8 Units per milliliter | Standard Deviation 6.8 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 5, Day 5, n=4,0 | -5.5 Units per milliliter | Standard Deviation 7.72 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 1, predose, n=4,0 | -2.3 Units per milliliter | Standard Deviation 4.03 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 1, 2 hour, n=4,0 | -2.8 Units per milliliter | Standard Deviation 6.9 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 3, 2 hour, n=4,0 | -4.8 Units per milliliter | Standard Deviation 8.54 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 6, Day 1, 4 hour, n=4,0 | -3.3 Units per milliliter | Standard Deviation 7.27 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, 4 hour, n=6,1 | 0.0 Units per milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 3, predose, n=6,1 | 0.0 Units per milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, 2 hour, n=6,1 | 0.0 Units per milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 2, n=6,1 | 0.0 Units per milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, 8 hour, n=6,1 | 0.0 Units per milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time | CH50, Session 1, Day 1, predose, n=6,1 | 0.0 Units per milliliter | — |
Secondary
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
Global Longitudinal Strain was measured by CMR at indicated time points. GLS included feature tracking and tagging by CMR. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, 6 month follow-up, n=2,0 | 1.234 Percentage of myocardial shortening | Standard Deviation 4.6888 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, Session 3, Day 24, n=6,0 | 0.229 Percentage of myocardial shortening | Standard Deviation 0.5836 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, Session 4, Day 24, n=5,0 | 0.392 Percentage of myocardial shortening | Standard Deviation 0.4121 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, Session 5, Day 24, n=4,0 | 0.349 Percentage of myocardial shortening | Standard Deviation 0.9354 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, 8 Week follow-up, n=6,1 | 1.125 Percentage of myocardial shortening | Standard Deviation 1.6448 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, 8 Week follow-up, n=6,1 | 0.639 Percentage of myocardial shortening | Standard Deviation 1.3678 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, Session 2, Day 24, n=6,0 | 0.003 Percentage of myocardial shortening | Standard Deviation 0.2907 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, 6 month follow-up, n=2,0 | -1.014 Percentage of myocardial shortening | Standard Deviation 0.3654 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, Session 2, Day 24, n=6,0 | 1.729 Percentage of myocardial shortening | Standard Deviation 2.3613 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, Session 3, Day 24, n=6,0 | 0.803 Percentage of myocardial shortening | Standard Deviation 2.3712 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, Session 4, Day 24, n=5,0 | 1.326 Percentage of myocardial shortening | Standard Deviation 4.0639 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, Session 5, Day 24, n=4,0 | 1.657 Percentage of myocardial shortening | Standard Deviation 2.1277 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Tagging, 8 Week follow-up, n=6,1 | -3.404 Percentage of myocardial shortening | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Global Longitudinal Strain (GLS) by CMR | GLS Feature Tracking, 8 Week follow-up, n=6,1 | 3.951 Percentage of myocardial shortening | — |
Secondary
Change From Baseline in GLS by ECHO
Global Longitudinal Strain was measured by ECHO at indicated time points. GLS included speckle tracking by ECHO. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, 6 month follow-up, n=4,0 | 0.40 Percentage of myocardial shortening | Standard Deviation 4.268 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, 8 Week follow-up, n=6,1 | -1.82 Percentage of myocardial shortening | Standard Deviation 10.013 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 1, Day 24, n=6,1 | -3.55 Percentage of myocardial shortening | Standard Deviation 5.709 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 2, Day 24, n=6,0 | -0.58 Percentage of myocardial shortening | Standard Deviation 6.013 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 3, Day 24, n=6,0 | -1.17 Percentage of myocardial shortening | Standard Deviation 7.487 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 4, Day 24, n=5,0 | 1.26 Percentage of myocardial shortening | Standard Deviation 5.299 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 5, Day 24, n=4,0 | 1.13 Percentage of myocardial shortening | Standard Deviation 9.044 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 6, Day 24, n=4,0 | -2.08 Percentage of myocardial shortening | Standard Deviation 4.555 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, Session 1, Day 24, n=6,1 | -0.90 Percentage of myocardial shortening | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in GLS by ECHO | GLS Speckle Tracking, 8 Week follow-up, n=6,1 | 1.60 Percentage of myocardial shortening | — |
Secondary
Change From Baseline in Inflammatory Biomarkers Over Time
Blood samples were collected for assessment of inflammatory biomarkers which included C-Reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum amyloid A protein (SAA). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 3, 8 hour, n=5,0 | 68.4699 Milligrams per Liter (mg/L) | Standard Deviation 75.51138 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 2, n=4,0 | 2.23 Milligrams per Liter (mg/L) | Standard Deviation 3.963 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 3, 4 hour, n=4,0 | 16.75 Milligrams per Liter (mg/L) | Standard Deviation 19.129 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 3, predose, n=3,0 | 8.33 Milligrams per Liter (mg/L) | Standard Deviation 11.517 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 3, 8 hour, n=3,0 | 14.67 Milligrams per Liter (mg/L) | Standard Deviation 12.58 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 5, n=3,0 | 14.10 Milligrams per Liter (mg/L) | Standard Deviation 7.146 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 6, n=3,0 | 17.33 Milligrams per Liter (mg/L) | Standard Deviation 7.844 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, predose, n=5,1 | -0.08 Milligrams per Liter (mg/L) | Standard Deviation 0.356 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, 2 hour, n=5,1 | -0.08 Milligrams per Liter (mg/L) | Standard Deviation 0.327 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 3, 4 hour, n=3,0 | 12.60 Milligrams per Liter (mg/L) | Standard Deviation 12.322 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 3, 8 hour, n=3,0 | 15.33 Milligrams per Liter (mg/L) | Standard Deviation 14.276 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 5, n=3,0 | 14.43 Milligrams per Liter (mg/L) | Standard Deviation 7.801 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 6, n=3,0 | 18.63 Milligrams per Liter (mg/L) | Standard Deviation 8.607 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, predose, n=5,1 | 0.2164 Milligrams per Liter (mg/L) | Standard Deviation 1.55486 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, 2 hour, n=5,1 | 0.1738 Milligrams per Liter (mg/L) | Standard Deviation 1.13909 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, 4 hour, n=5,1 | 0.3902 Milligrams per Liter (mg/L) | Standard Deviation 1.56253 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, 8 hour, n=5,1 | 0.2695 Milligrams per Liter (mg/L) | Standard Deviation 1.57992 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 2, n=5,1 | 2.9247 Milligrams per Liter (mg/L) | Standard Deviation 3.47577 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 3, predose, n=5,1 | 50.7137 Milligrams per Liter (mg/L) | Standard Deviation 55.02969 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 3, 2 hour, n=5,0 | 54.8466 Milligrams per Liter (mg/L) | Standard Deviation 59.36005 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 3, 4 hour, n=5,0 | 54.9329 Milligrams per Liter (mg/L) | Standard Deviation 55.92645 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 1, 4 hour, n=5,0 | 2.18 Milligrams per Liter (mg/L) | Standard Deviation 2.71 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, 4 hour, n=4,1 | -0.20 Milligrams per Liter (mg/L) | Standard Deviation 0.271 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, 8 hour, n=5,1 | -0.10 Milligrams per Liter (mg/L) | Standard Deviation 0.406 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 5, n=4,0 | 28.13 Milligrams per Liter (mg/L) | Standard Deviation 21.919 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 5, n=5,0 | 54.6741 Milligrams per Liter (mg/L) | Standard Deviation 69.66316 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 3, 2 hour, n=5,0 | 145.2507 Milligrams per Liter (mg/L) | Standard Deviation 171.92591 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 3, 8 hour, n=3,0 | 14.5333 Milligrams per Liter (mg/L) | Standard Deviation 12.2646 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, predose, n=5,1 | -0.12 Milligrams per Liter (mg/L) | Standard Deviation 0.572 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, 2 hour, n=5,1 | -0.26 Milligrams per Liter (mg/L) | Standard Deviation 0.573 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, 4 hour, n=4,1 | -0.28 Milligrams per Liter (mg/L) | Standard Deviation 0.486 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, 8 hour, n=5,1 | -0.18 Milligrams per Liter (mg/L) | Standard Deviation 0.634 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 2, n=5,1 | 0.64 Milligrams per Liter (mg/L) | Standard Deviation 1.701 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 3, predose, n=5,1 | 14.08 Milligrams per Liter (mg/L) | Standard Deviation 12.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 3, 2 hour, n=5,0 | 14.52 Milligrams per Liter (mg/L) | Standard Deviation 13.128 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 3, 4 hour, n=5,0 | 15.30 Milligrams per Liter (mg/L) | Standard Deviation 13.119 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 3, 8 hour, n=5,0 | 17.64 Milligrams per Liter (mg/L) | Standard Deviation 14.527 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 5, n=5,0 | 17.20 Milligrams per Liter (mg/L) | Standard Deviation 14.772 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 6, n=5,0 | 19.52 Milligrams per Liter (mg/L) | Standard Deviation 15.665 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 1, predose, n=5,0 | 2.24 Milligrams per Liter (mg/L) | Standard Deviation 2.864 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 5, n=5,0 | 19.00 Milligrams per Liter (mg/L) | Standard Deviation 15.625 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 6, n=4,0 | 24.10 Milligrams per Liter (mg/L) | Standard Deviation 16.785 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 1, predose, n=4,0 | 2.33 Milligrams per Liter (mg/L) | Standard Deviation 4.487 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 1, 2 hour, n=5,0 | 2.12 Milligrams per Liter (mg/L) | Standard Deviation 2.613 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 1, 8 hour, n=5,0 | 2.18 Milligrams per Liter (mg/L) | Standard Deviation 2.658 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 1, 2 hour, n=4,0 | 2.53 Milligrams per Liter (mg/L) | Standard Deviation 4.762 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 1, 4 hour, n=4,0 | 2.45 Milligrams per Liter (mg/L) | Standard Deviation 4.669 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 2, n=4,0 | 2.00 Milligrams per Liter (mg/L) | Standard Deviation 2.624 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 3, predose, n=5,0 | 27.42 Milligrams per Liter (mg/L) | Standard Deviation 26.283 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 3, 2 hour, n=5,0 | 29.46 Milligrams per Liter (mg/L) | Standard Deviation 27.415 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 1, 8 hour, n=4,0 | 2.40 Milligrams per Liter (mg/L) | Standard Deviation 4.455 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 3, 4 hour, n=5,0 | 30.90 Milligrams per Liter (mg/L) | Standard Deviation 27.961 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 3, 8 hour, n=5,0 | 31.76 Milligrams per Liter (mg/L) | Standard Deviation 27.897 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 3, predose, n=4,0 | 12.45 Milligrams per Liter (mg/L) | Standard Deviation 13.533 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 5, n=4,0 | 28.33 Milligrams per Liter (mg/L) | Standard Deviation 22.386 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 2, Day 6, n=5,0 | 27.04 Milligrams per Liter (mg/L) | Standard Deviation 18.632 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 1, predose, n=4,0 | 1.93 Milligrams per Liter (mg/L) | Standard Deviation 2.343 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 1, 2 hour, n=4,0 | 2.05 Milligrams per Liter (mg/L) | Standard Deviation 2.626 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 1, 4 hour, n=4,0 | 2.15 Milligrams per Liter (mg/L) | Standard Deviation 2.891 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 1, 8 hour, n=4,0 | 2.15 Milligrams per Liter (mg/L) | Standard Deviation 2.76 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 2, n=4,0 | 1.75 Milligrams per Liter (mg/L) | Standard Deviation 2.161 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 3, predose, n=4,0 | 18.13 Milligrams per Liter (mg/L) | Standard Deviation 15.476 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 3, 2 hour, n=4,0 | 19.40 Milligrams per Liter (mg/L) | Standard Deviation 16.403 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 3, 4 hour, n=4,0 | 21.20 Milligrams per Liter (mg/L) | Standard Deviation 17.827 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 3, Day 3, 8 hour, n=4,0 | 22.63 Milligrams per Liter (mg/L) | Standard Deviation 18.466 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 3, 2 hour, n=4,0 | 14.75 Milligrams per Liter (mg/L) | Standard Deviation 16.539 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 3, 8 hour, n=4,0 | 17.30 Milligrams per Liter (mg/L) | Standard Deviation 17.83 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 5, n=4,0 | 18.43 Milligrams per Liter (mg/L) | Standard Deviation 9.959 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 2, n=5,1 | 0.56 Milligrams per Liter (mg/L) | Standard Deviation 1.286 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 3, predose, n=5,1 | 14.54 Milligrams per Liter (mg/L) | Standard Deviation 13.149 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 4, Day 6, n=4,0 | 19.98 Milligrams per Liter (mg/L) | Standard Deviation 11.277 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 1, predose, n=3,0 | 2.23 Milligrams per Liter (mg/L) | Standard Deviation 3.439 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 1, 2 hour, n=3,0 | 2.13 Milligrams per Liter (mg/L) | Standard Deviation 3.35 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 1, 4 hour, n=3,0 | 1.97 Milligrams per Liter (mg/L) | Standard Deviation 3.147 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 6, n=5,0 | 55.2882 Milligrams per Liter (mg/L) | Standard Deviation 63.7787 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 1, predose, n=5,0 | 1.0277 Milligrams per Liter (mg/L) | Standard Deviation 1.64965 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 1, 2 hour, n=5,0 | 0.9841 Milligrams per Liter (mg/L) | Standard Deviation 2.22042 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 1, 4 hour, n=5,0 | 1.4543 Milligrams per Liter (mg/L) | Standard Deviation 2.61184 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 1, 8 hour, n=5,0 | 1.0588 Milligrams per Liter (mg/L) | Standard Deviation 1.52455 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 2, n=5,0 | 3.7244 Milligrams per Liter (mg/L) | Standard Deviation 1.63856 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 3, predose, n=5,0 | 134.4489 Milligrams per Liter (mg/L) | Standard Deviation 160.14208 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 3, 4 hour, n=5,0 | 142.5438 Milligrams per Liter (mg/L) | Standard Deviation 174.11156 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 3, 8 hour, n=5,0 | 100.8836 Milligrams per Liter (mg/L) | Standard Deviation 184.35963 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 5, n=5,0 | 76.8593 Milligrams per Liter (mg/L) | Standard Deviation 136.83379 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 2, Day 6, n=5,0 | 101.0688 Milligrams per Liter (mg/L) | Standard Deviation 105.88787 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 1, predose, n=4,0 | 0.2428 Milligrams per Liter (mg/L) | Standard Deviation 1.13002 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 1, 2 hour, n=4,0 | 0.1863 Milligrams per Liter (mg/L) | Standard Deviation 1.06333 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 1, 4 hour, n=4,0 | 0.0475 Milligrams per Liter (mg/L) | Standard Deviation 1.00422 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 1, 8 hour, n=5,0 | 4.0339 Milligrams per Liter (mg/L) | Standard Deviation 8.62955 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 2, n=4,0 | 6.4822 Milligrams per Liter (mg/L) | Standard Deviation 11.14119 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 3, predose, n=5,0 | 54.7393 Milligrams per Liter (mg/L) | Standard Deviation 82.22346 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 3, 2 hour, n=5,0 | 58.0526 Milligrams per Liter (mg/L) | Standard Deviation 83.12677 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 3, 4 hour, n=5,0 | 64.1995 Milligrams per Liter (mg/L) | Standard Deviation 93.61736 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 3, 8 hour, n=5,0 | 66.9605 Milligrams per Liter (mg/L) | Standard Deviation 93.98658 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 5, n=5,0 | 58.6742 Milligrams per Liter (mg/L) | Standard Deviation 50.93398 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 3, Day 6, n=5,0 | 49.4029 Milligrams per Liter (mg/L) | Standard Deviation 46.30012 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 1, predose, n=4,0 | -0.1305 Milligrams per Liter (mg/L) | Standard Deviation 1.86822 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 1, 2 hour, n=4,0 | 0.0159 Milligrams per Liter (mg/L) | Standard Deviation 1.91086 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 1, 4 hour, n=4,0 | -0.0013 Milligrams per Liter (mg/L) | Standard Deviation 1.84104 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 1, 8 hour, n=4,0 | 0.1997 Milligrams per Liter (mg/L) | Standard Deviation 1.70496 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 2, n=4,0 | 1.6015 Milligrams per Liter (mg/L) | Standard Deviation 1.07082 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 3, predose, n=4,0 | 45.1067 Milligrams per Liter (mg/L) | Standard Deviation 82.67535 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 3, 2 hour, n=4,0 | 51.0650 Milligrams per Liter (mg/L) | Standard Deviation 94.33211 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 3, 4 hour, n=4,0 | 55.0009 Milligrams per Liter (mg/L) | Standard Deviation 101.37965 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 3, 8 hour, n=4,0 | 55.7135 Milligrams per Liter (mg/L) | Standard Deviation 101.39069 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 5, n=4,0 | 51.2002 Milligrams per Liter (mg/L) | Standard Deviation 54.8478 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 4, Day 6, n=4,0 | 41.2457 Milligrams per Liter (mg/L) | Standard Deviation 38.77052 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 1, predose, n=3,0 | -0.1498 Milligrams per Liter (mg/L) | Standard Deviation 1.04561 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 1, 2 hour, n=3,0 | -0.2399 Milligrams per Liter (mg/L) | Standard Deviation 0.89843 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 1, 4 hour, n=3,0 | -0.1906 Milligrams per Liter (mg/L) | Standard Deviation 0.94124 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 1, 8 hour, n=3,0 | -0.1771 Milligrams per Liter (mg/L) | Standard Deviation 0.95814 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 2, n=3,0 | 0.1380 Milligrams per Liter (mg/L) | Standard Deviation 0.61958 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 3, predose, n=3,0 | 10.8884 Milligrams per Liter (mg/L) | Standard Deviation 17.72052 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 3, 2 hour, n=3,0 | 8.6783 Milligrams per Liter (mg/L) | Standard Deviation 11.48176 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 3, 4 hour, n=3,0 | 9.2527 Milligrams per Liter (mg/L) | Standard Deviation 11.23663 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 3, 8 hour, n=3,0 | 13.7941 Milligrams per Liter (mg/L) | Standard Deviation 19.39827 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 5, n=3,0 | 66.2542 Milligrams per Liter (mg/L) | Standard Deviation 107.98594 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 5, Day 6, n=3,0 | 73.0823 Milligrams per Liter (mg/L) | Standard Deviation 118.07036 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 1, predose, n=3,0 | 1.2964 Milligrams per Liter (mg/L) | Standard Deviation 1.75482 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 1, 2 hour, n=3,0 | 1.0538 Milligrams per Liter (mg/L) | Standard Deviation 1.74392 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 1, 4 hour, n=3,0 | 1.3139 Milligrams per Liter (mg/L) | Standard Deviation 2.18542 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 1, 8 hour, n=3,0 | 0.9078 Milligrams per Liter (mg/L) | Standard Deviation 1.725 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 2, n=3,0 | 1.2641 Milligrams per Liter (mg/L) | Standard Deviation 0.89837 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 3, predose, n=3,0 | 7.4697 Milligrams per Liter (mg/L) | Standard Deviation 5.41886 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 3, 2 hour, n=3,0 | 8.3574 Milligrams per Liter (mg/L) | Standard Deviation 4.40865 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 3, 4 hour, n=3,0 | 11.0305 Milligrams per Liter (mg/L) | Standard Deviation 8.80978 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 5, n=3,0 | 25.2529 Milligrams per Liter (mg/L) | Standard Deviation 27.55204 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 6, Day 6, n=3,0 | 32.6318 Milligrams per Liter (mg/L) | Standard Deviation 41.82856 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 1, 8 hour, n=3,0 | 2.10 Milligrams per Liter (mg/L) | Standard Deviation 3.378 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 2, n=3,0 | 1.37 Milligrams per Liter (mg/L) | Standard Deviation 2.811 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 3, 2 hour, n=5,0 | 15.14 Milligrams per Liter (mg/L) | Standard Deviation 13.363 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 3, 4 hour, n=5,0 | 15.84 Milligrams per Liter (mg/L) | Standard Deviation 13.607 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 3, 8 hour, n=5,0 | 17.10 Milligrams per Liter (mg/L) | Standard Deviation 14.294 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 5, n=5,0 | 16.70 Milligrams per Liter (mg/L) | Standard Deviation 14.332 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 6, n=5,0 | 18.60 Milligrams per Liter (mg/L) | Standard Deviation 14.778 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 1, predose, n=5,0 | 1.88 Milligrams per Liter (mg/L) | Standard Deviation 2.539 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 1, predose, n=4,0 | 1.60 Milligrams per Liter (mg/L) | Standard Deviation 2.017 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 1, 2 hour, n=5,0 | 1.78 Milligrams per Liter (mg/L) | Standard Deviation 2.351 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 1, 4 hour, n=5,0 | 1.90 Milligrams per Liter (mg/L) | Standard Deviation 2.478 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 1, 8 hour, n=5,0 | 1.78 Milligrams per Liter (mg/L) | Standard Deviation 2.179 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 2, n=4,0 | 1.75 Milligrams per Liter (mg/L) | Standard Deviation 2.266 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 3, predose, n=5,0 | 26.76 Milligrams per Liter (mg/L) | Standard Deviation 26.122 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 3, 2 hour, n=5,0 | 29.28 Milligrams per Liter (mg/L) | Standard Deviation 27.373 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 3, 4 hour, n=5,0 | 30.36 Milligrams per Liter (mg/L) | Standard Deviation 27.018 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 3, 8 hour, n=5,0 | 31.10 Milligrams per Liter (mg/L) | Standard Deviation 26.885 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 2, Day 6, n=5,0 | 27.20 Milligrams per Liter (mg/L) | Standard Deviation 18.468 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 1, 2 hour, n=4,0 | 1.63 Milligrams per Liter (mg/L) | Standard Deviation 2.175 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 1, 4 hour, n=4,0 | 1.70 Milligrams per Liter (mg/L) | Standard Deviation 2.403 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 1, 8 hour, n=4,0 | 1.65 Milligrams per Liter (mg/L) | Standard Deviation 2.161 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 3, 2 hour, n=3,0 | 9.87 Milligrams per Liter (mg/L) | Standard Deviation 12.881 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 2, n=4,0 | 1.25 Milligrams per Liter (mg/L) | Standard Deviation 1.754 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 3, predose, n=4,0 | 17.88 Milligrams per Liter (mg/L) | Standard Deviation 15.954 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 3, 2 hour, n=4,0 | 19.23 Milligrams per Liter (mg/L) | Standard Deviation 16.675 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 3, 4 hour, n=4,0 | 20.58 Milligrams per Liter (mg/L) | Standard Deviation 17.733 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 3, 8 hour, n=4,0 | 22.10 Milligrams per Liter (mg/L) | Standard Deviation 18.149 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 5, n=4,0 | 22.45 Milligrams per Liter (mg/L) | Standard Deviation 15.042 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 3, Day 6, n=4,0 | 23.73 Milligrams per Liter (mg/L) | Standard Deviation 16.141 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 1, predose, n=4,0 | 2.28 Milligrams per Liter (mg/L) | Standard Deviation 4.043 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 1, 2 hour, n=4,0 | 2.53 Milligrams per Liter (mg/L) | Standard Deviation 4.61 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 1, 4 hour, n=4,0 | 2.53 Milligrams per Liter (mg/L) | Standard Deviation 4.479 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 1, 8 hour, n=4,0 | 2.58 Milligrams per Liter (mg/L) | Standard Deviation 4.528 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 2, n=4,0 | 2.20 Milligrams per Liter (mg/L) | Standard Deviation 3.558 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 3, predose, n=4,0 | 12.33 Milligrams per Liter (mg/L) | Standard Deviation 13.881 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 3, 2 hour, n=4,0 | 14.40 Milligrams per Liter (mg/L) | Standard Deviation 16.324 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 3, 4 hour, n=4,0 | 16.00 Milligrams per Liter (mg/L) | Standard Deviation 18.24 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 3, 8 hour, n=4,0 | 17.08 Milligrams per Liter (mg/L) | Standard Deviation 17.972 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 5, n=4,0 | 19.60 Milligrams per Liter (mg/L) | Standard Deviation 10.903 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 4, Day 6, n=4,0 | 20.73 Milligrams per Liter (mg/L) | Standard Deviation 11.391 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 1, predose, n=3,0 | 2.03 Milligrams per Liter (mg/L) | Standard Deviation 3.349 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 1, 2 hour, n=3,0 | 1.97 Milligrams per Liter (mg/L) | Standard Deviation 3.32 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 1, 4 hour, n=3,0 | 1.83 Milligrams per Liter (mg/L) | Standard Deviation 3.175 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 1, 8 hour, n=3,0 | 1.87 Milligrams per Liter (mg/L) | Standard Deviation 3.323 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 2, n=3,0 | 1.23 Milligrams per Liter (mg/L) | Standard Deviation 2.574 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 3, predose, n=3,0 | 9.10 Milligrams per Liter (mg/L) | Standard Deviation 13.182 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 3, 2 hour, n=3,0 | 10.43 Milligrams per Liter (mg/L) | Standard Deviation 14.629 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 3, 4 hour, n=3,0 | 11.17 Milligrams per Liter (mg/L) | Standard Deviation 14.865 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 3, 4 hour, n=3,0 | 10.47 Milligrams per Liter (mg/L) | Standard Deviation 12.874 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 3, 8 hour, n=3,0 | 12.90 Milligrams per Liter (mg/L) | Standard Deviation 14.944 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 5, n=2,0 | 34.30 Milligrams per Liter (mg/L) | Standard Deviation 40.588 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 3, 8 hour, n=3,0 | 12.67 Milligrams per Liter (mg/L) | Standard Deviation 15.557 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 5, n=2,0 | 33.95 Milligrams per Liter (mg/L) | Standard Deviation 40.941 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 5, Day 6, n=2,0 | 34.80 Milligrams per Liter (mg/L) | Standard Deviation 34.083 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 1, predose, n=3,0 | 3.77 Milligrams per Liter (mg/L) | Standard Deviation 3.853 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 1, 2 hour, n=3,0 | 3.37 Milligrams per Liter (mg/L) | Standard Deviation 3.523 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 1, 4 hour, n=3,0 | 3.50 Milligrams per Liter (mg/L) | Standard Deviation 3.799 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 1, 8 hour, n=3,0 | 3.27 Milligrams per Liter (mg/L) | Standard Deviation 3.584 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 2, n=3,0 | 2.33 Milligrams per Liter (mg/L) | Standard Deviation 2.775 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 3, predose, n=3,0 | 8.97 Milligrams per Liter (mg/L) | Standard Deviation 9.752 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 6, Day 3, 2 hour, n=3,0 | 10.57 Milligrams per Liter (mg/L) | Standard Deviation 11.075 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 5, Day 6, n=2,0 | 35.20 Milligrams per Liter (mg/L) | Standard Deviation 34.931 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 1, predose, n=3,0 | 4.00 Milligrams per Liter (mg/L) | Standard Deviation 3.851 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 1, 2 hour, n=3,0 | 3.63 Milligrams per Liter (mg/L) | Standard Deviation 3.711 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 1, 4 hour, n=3,0 | 3.70 Milligrams per Liter (mg/L) | Standard Deviation 3.835 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 1, 8 hour, n=3,0 | 3.70 Milligrams per Liter (mg/L) | Standard Deviation 3.874 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 2, n=3,0 | 2.63 Milligrams per Liter (mg/L) | Standard Deviation 2.914 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 3, predose, n=3,0 | 9.17 Milligrams per Liter (mg/L) | Standard Deviation 8.879 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 3, 2 hour, n=3,0 | 11.10 Milligrams per Liter (mg/L) | Standard Deviation 10.887 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 6, Day 3, 4 hour, n=3,0 | 12.70 Milligrams per Liter (mg/L) | Standard Deviation 11.555 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, 2 hour, n=5,1 | -3.70 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, 8 hour, n=5,1 | -14.8767 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 3, predose, n=5,1 | 131.20 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, 2 hour, n=5,1 | -22.4187 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, predose, n=5,1 | -22.3723 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 3, predose, n=5,1 | 1437.7667 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 1, 4 hour, n=5,1 | -21.7463 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 3, predose, n=5,1 | 135.20 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, 4 hour, n=4,1 | -3.70 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, predose, n=5,1 | -4.60 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, 8 hour, n=5,1 | -3.60 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, 2 hour, n=5,1 | -4.80 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 1, predose, n=5,1 | -3.60 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, 4 hour, n=4,1 | -4.70 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | hsCRP, Session 1, Day 2, n=5,1 | 41.40 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 1, 8 hour, n=5,1 | -4.60 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | SAA, Session 1, Day 2, n=5,1 | 322.2895 Milligrams per Liter (mg/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Inflammatory Biomarkers Over Time | CRP, Session 1, Day 2, n=5,1 | 44.70 Milligrams per Liter (mg/L) | — |
Secondary
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | Session 4, Day 24, n=5,0 | -5.262 Milliliter | Standard Deviation 5.3765 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | Session 2, Day 24, n=6,0 | -3.473 Milliliter | Standard Deviation 11.2584 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | Session 3, Day 24, n=6,0 | 1.653 Milliliter | Standard Deviation 7.3322 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | 8 Week follow-up, n=6,1 | 9.887 Milliliter | Standard Deviation 19.3925 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | Session 5, Day 24, n=4,0 | -9.323 Milliliter | Standard Deviation 11.5275 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | 6 month follow-up, n=2,0 | -21.030 Milliliter | Standard Deviation 8.0469 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR | 8 Week follow-up, n=6,1 | -4.560 Milliliter | — |
Secondary
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | 6 month follow-up, n=4,0 | -12.045 Milliliter | Standard Deviation 20.2972 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | 8 Week follow-up, n=6,1 | -7.648 Milliliter | Standard Deviation 4.463 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 1, Day 24, n=6,1 | 0.050 Milliliter | Standard Deviation 4.6276 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 2, Day 24, n=6,0 | -2.940 Milliliter | Standard Deviation 10.232 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 3, Day 24, n=6,0 | -2.922 Milliliter | Standard Deviation 14.0019 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 4, Day 24, n=5,0 | -12.338 Milliliter | Standard Deviation 10.2249 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 5, Day 24, n=4,0 | -11.860 Milliliter | Standard Deviation 14.5676 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 6, Day 24, n=4,0 | -5.073 Milliliter | Standard Deviation 11.3679 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | Session 1, Day 24, n=6,1 | -1.790 Milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO | 8 Week follow-up, n=6,1 | -7.100 Milliliter | — |
Secondary
Change From Baseline in Left Ventricular EF by ECHO
Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | 6 month follow-up, n=4,0 | 1.20 Percentage of ejected blood | Standard Deviation 3.442 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | 8 Week follow-up, n=6,1 | -1.72 Percentage of ejected blood | Standard Deviation 8.471 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 1, Day 24, n=6,1 | 2.10 Percentage of ejected blood | Standard Deviation 5.707 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 2, Day 24, n=6,0 | -0.38 Percentage of ejected blood | Standard Deviation 3.111 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 3, Day 24, n=6,0 | -0.30 Percentage of ejected blood | Standard Deviation 3.318 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 4, Day 24, n=5,0 | -2.74 Percentage of ejected blood | Standard Deviation 5.766 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 5, Day 24, n=4,0 | -4.05 Percentage of ejected blood | Standard Deviation 7.832 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 6, Day 24, n=4,0 | -3.53 Percentage of ejected blood | Standard Deviation 3.288 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricular EF by ECHO | Session 1, Day 24, n=6,1 | -7.40 Percentage of ejected blood | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricular EF by ECHO | 8 Week follow-up, n=6,1 | -3.20 Percentage of ejected blood | — |
Secondary
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | Session 5, Day 24, n=4,0 | -3.257 Percentage of ejected blood | Standard Deviation 7.9513 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | Session 3, Day 24, n=6,0 | 0.687 Percentage of ejected blood | Standard Deviation 11.7171 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | Session 4, Day 24, n=5,0 | -3.380 Percentage of ejected blood | Standard Deviation 5.475 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | Session 2, Day 24, n=6,0 | 0.100 Percentage of ejected blood | Standard Deviation 3.9071 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | 8 Week follow-up, n=6,1 | -1.258 Percentage of ejected blood | Standard Deviation 7.9932 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | 6 month follow-up, n=2,0 | 0.680 Percentage of ejected blood | Standard Deviation 8.7681 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR | 8 Week follow-up, n=6,1 | -2.800 Percentage of ejected blood | — |
Secondary
Change From Baseline in LV Twist Over Time
LV twist was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in LV Twist Over Time | Session 5, Day 24, n=4,0 | -0.628 Degree | Standard Deviation 1.2269 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in LV Twist Over Time | Session 3, Day 24, n=6,0 | 0.431 Degree | Standard Deviation 2.4369 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in LV Twist Over Time | Session 4, Day 24, n=5,0 | -0.611 Degree | Standard Deviation 1.8979 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in LV Twist Over Time | Session 2, Day 24, n=5,0 | 0.550 Degree | Standard Deviation 1.6672 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in LV Twist Over Time | 8 Week follow-up, n=6,1 | -0.264 Degree | Standard Deviation 2.0835 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in LV Twist Over Time | 6 month follow-up, n=2,0 | -0.633 Degree | Standard Deviation 0.3349 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in LV Twist Over Time | 8 Week follow-up, n=6,1 | 0.914 Degree | — |
Secondary
Change From Baseline in Plasma Cytokines Over Time
Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ.
Time frame: Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 3, predose, n=4,0 | 25.338 Nanograms per liter (ng/L) | Standard Deviation 17.9965 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 3, 1 hour, n=6,0 | 1.240 Nanograms per liter (ng/L) | Standard Deviation 0.9968 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 3, predose, n=4,0 | 0.278 Nanograms per liter (ng/L) | Standard Deviation 1.9987 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 3, 6 hour, n=4,0 | -0.585 Nanograms per liter (ng/L) | Standard Deviation 1.3026 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 4, n=4,0 | -0.368 Nanograms per liter (ng/L) | Standard Deviation 1.128 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 3, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 3, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 3, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 3, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 4, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, predose, n=6,1 | 4.377 Nanograms per liter (ng/L) | Standard Deviation 5.8881 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, 1 hour, n=6,1 | 4.887 Nanograms per liter (ng/L) | Standard Deviation 12.0436 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, 3 hour, n=6,1 | 1.097 Nanograms per liter (ng/L) | Standard Deviation 6.7834 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, 6 hour, n=6,1 | 4.400 Nanograms per liter (ng/L) | Standard Deviation 9.5 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 2, n=6,1 | 10.977 Nanograms per liter (ng/L) | Standard Deviation 25.4607 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 1, 1 hour, n=6,0 | 1.592 Nanograms per liter (ng/L) | Standard Deviation 6.9965 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 1, 3 hour, n=6,0 | 0.275 Nanograms per liter (ng/L) | Standard Deviation 7.2669 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 1, 6 hour, n=6,0 | 1.243 Nanograms per liter (ng/L) | Standard Deviation 6.1976 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 2, n=6,0 | 5.468 Nanograms per liter (ng/L) | Standard Deviation 7.5652 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 3, predose, n=6,0 | 8.322 Nanograms per liter (ng/L) | Standard Deviation 5.0082 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 3, 1 hour, n=6,0 | 6.432 Nanograms per liter (ng/L) | Standard Deviation 10.6402 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 3, 3 hour, n=6,0 | -1.107 Nanograms per liter (ng/L) | Standard Deviation 5.816 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 3, 6 hour, n=6,0 | -0.870 Nanograms per liter (ng/L) | Standard Deviation 4.6278 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 4, n=6,0 | 1.667 Nanograms per liter (ng/L) | Standard Deviation 5.517 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 5, n=6,0 | 2.853 Nanograms per liter (ng/L) | Standard Deviation 5.4769 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day -2, n=5,0 | 12.742 Nanograms per liter (ng/L) | Standard Deviation 7.8571 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 1, predose, n=6,0 | 7.635 Nanograms per liter (ng/L) | Standard Deviation 6.3602 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 1, 1 hour, n=6,0 | 3.848 Nanograms per liter (ng/L) | Standard Deviation 5.5264 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 1, 3 hour, n=6,0 | -0.517 Nanograms per liter (ng/L) | Standard Deviation 5.6983 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 1, 6 hour, n=6,0 | 0.933 Nanograms per liter (ng/L) | Standard Deviation 8.0166 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 2, n=5,0 | 3.024 Nanograms per liter (ng/L) | Standard Deviation 5.5819 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 3, predose, n=6,0 | 14.440 Nanograms per liter (ng/L) | Standard Deviation 13.4971 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 3, 1 hour, n=6,0 | 4.887 Nanograms per liter (ng/L) | Standard Deviation 5.213 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 3, 3 hour, n=6,0 | 0.088 Nanograms per liter (ng/L) | Standard Deviation 4.397 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 3, 6 hour, n=6,0 | 2.450 Nanograms per liter (ng/L) | Standard Deviation 6.2029 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 4, n=6,0 | 3.680 Nanograms per liter (ng/L) | Standard Deviation 4.5662 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 3, Day 5, n=6,0 | 7.783 Nanograms per liter (ng/L) | Standard Deviation 3.9382 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day -2, n=5,0 | 15.686 Nanograms per liter (ng/L) | Standard Deviation 10.4436 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 1, predose, n=5,0 | 9.910 Nanograms per liter (ng/L) | Standard Deviation 11.2178 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 1, 1 hour, n=5,0 | 10.088 Nanograms per liter (ng/L) | Standard Deviation 13.7154 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 1, 3 hour, n=5,0 | 5.242 Nanograms per liter (ng/L) | Standard Deviation 11.1547 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 1, 6 hour, n=5,0 | 6.992 Nanograms per liter (ng/L) | Standard Deviation 12.0857 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 2, n=5,0 | 4.282 Nanograms per liter (ng/L) | Standard Deviation 8.9442 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 3, predose, n=5,0 | 15.072 Nanograms per liter (ng/L) | Standard Deviation 11.836 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 3, 1 hour, n=5,0 | 10.536 Nanograms per liter (ng/L) | Standard Deviation 8.8924 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 3, predose, n=6,1 | 6.830 Nanograms per liter (ng/L) | Standard Deviation 10.6309 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 3, 1 hour, n=6,0 | 3.035 Nanograms per liter (ng/L) | Standard Deviation 6.9193 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 3, 3 hour, n=6,0 | -0.788 Nanograms per liter (ng/L) | Standard Deviation 4.984 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 3, 6 hour, n=6,0 | -0.490 Nanograms per liter (ng/L) | Standard Deviation 7.3654 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 4, n=6,0 | -0.542 Nanograms per liter (ng/L) | Standard Deviation 5.048 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 3, 6 hour, n=5,0 | 1.208 Nanograms per liter (ng/L) | Standard Deviation 3.6252 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 4, n=5,0 | 7.118 Nanograms per liter (ng/L) | Standard Deviation 14.6164 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 5, n=4,0 | -1.795 Nanograms per liter (ng/L) | Standard Deviation 4.8526 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day -2, n=4,0 | 21.055 Nanograms per liter (ng/L) | Standard Deviation 14.5161 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 1, predose, n=4,0 | 18.213 Nanograms per liter (ng/L) | Standard Deviation 16.0292 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 1, 1 hour, n=4,0 | 17.667 Nanograms per liter (ng/L) | Standard Deviation 15.202 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 1, 3 hour, n=4,0 | 12.463 Nanograms per liter (ng/L) | Standard Deviation 16.7548 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 1, 6 hour, n=4,0 | 5.617 Nanograms per liter (ng/L) | Standard Deviation 8.7263 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 2, n=4,0 | 5.463 Nanograms per liter (ng/L) | Standard Deviation 9.5943 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 3, predose, n=4,0 | 16.915 Nanograms per liter (ng/L) | Standard Deviation 13.4207 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 3, 1 hour, n=4,0 | 9.240 Nanograms per liter (ng/L) | Standard Deviation 11.0353 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 3, 3 hour, n=4,0 | 5.902 Nanograms per liter (ng/L) | Standard Deviation 9.1992 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 4, n=4,0 | 7.610 Nanograms per liter (ng/L) | Standard Deviation 12.4139 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 5, n=4,0 | 7.330 Nanograms per liter (ng/L) | Standard Deviation 14.2059 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day -2, n=4,0 | 12.908 Nanograms per liter (ng/L) | Standard Deviation 11.254 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 1, 3 hour, n=4,0 | 13.823 Nanograms per liter (ng/L) | Standard Deviation 18.3486 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 1, 6 hour, n=4,0 | 12.923 Nanograms per liter (ng/L) | Standard Deviation 15.0125 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 2, n=4,0 | 13.338 Nanograms per liter (ng/L) | Standard Deviation 15.707 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 3, predose, n=4,0 | 0.393 Nanograms per liter (ng/L) | Standard Deviation 0.4774 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 3, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 1, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 1, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 1, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 1, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 3, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 3, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 3, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 3, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 5, n=6,0 | 1.198 Nanograms per liter (ng/L) | Standard Deviation 3.0063 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 4, Day 3, 3 hour, n=5,0 | 1.474 Nanograms per liter (ng/L) | Standard Deviation 3.3523 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 5, Day 3, 6 hour, n=4,0 | 5.335 Nanograms per liter (ng/L) | Standard Deviation 7.4134 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 1, predose, n=4,0 | 17.575 Nanograms per liter (ng/L) | Standard Deviation 14.9713 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 1, 1 hour, n=4,0 | 18.718 Nanograms per liter (ng/L) | Standard Deviation 14.2024 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 3, 1 hour, n=4,0 | 11.733 Nanograms per liter (ng/L) | Standard Deviation 12.1142 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 3, 3 hour, n=4,0 | 6.853 Nanograms per liter (ng/L) | Standard Deviation 7.9858 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 3, 6 hour, n=4,0 | 7.220 Nanograms per liter (ng/L) | Standard Deviation 9.8022 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 4, n=4,0 | 13.500 Nanograms per liter (ng/L) | Standard Deviation 13.0942 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 6, Day 5, n=4,0 | 14.130 Nanograms per liter (ng/L) | Standard Deviation 9.1046 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 1, 6 hour, n=4,0 | -1.213 Nanograms per liter (ng/L) | Standard Deviation 1.5189 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 2, n=4,0 | 0.905 Nanograms per liter (ng/L) | Standard Deviation 4.092 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 3, predose, n=4,0 | 7.323 Nanograms per liter (ng/L) | Standard Deviation 4.8265 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 3, 1 hour, n=4,0 | 4.240 Nanograms per liter (ng/L) | Standard Deviation 3.6214 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 3, 3 hour, n=4,0 | -0.125 Nanograms per liter (ng/L) | Standard Deviation 0.7543 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 3, 6 hour, n=4,0 | -1.390 Nanograms per liter (ng/L) | Standard Deviation 1.3301 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 4, n=4,0 | 3.598 Nanograms per liter (ng/L) | Standard Deviation 5.7476 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 5, n=4,0 | 6.533 Nanograms per liter (ng/L) | Standard Deviation 2.6812 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day -2, n=4,0 | 1.383 Nanograms per liter (ng/L) | Standard Deviation 1.8535 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 1, predose, n=4,0 | 0.565 Nanograms per liter (ng/L) | Standard Deviation 1.4007 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 1, 1 hour, n=4,0 | 0.077 Nanograms per liter (ng/L) | Standard Deviation 1.12 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 1, 3 hour, n=4,0 | -0.413 Nanograms per liter (ng/L) | Standard Deviation 1.4416 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 1, 6 hour, n=4,0 | -1.165 Nanograms per liter (ng/L) | Standard Deviation 0.9786 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 2, n=4,0 | 0.932 Nanograms per liter (ng/L) | Standard Deviation 4.034 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 3, predose, n=4,0 | 15.008 Nanograms per liter (ng/L) | Standard Deviation 13.001 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 3, 1 hour, n=4,0 | 10.083 Nanograms per liter (ng/L) | Standard Deviation 9.2076 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 3, 3 hour, n=4,0 | 1.435 Nanograms per liter (ng/L) | Standard Deviation 1.7505 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 3, 6 hour, n=4,0 | -1.005 Nanograms per liter (ng/L) | Standard Deviation 1.3522 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 4, n=4,0 | 1.740 Nanograms per liter (ng/L) | Standard Deviation 3.2649 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 6, Day 5, n=4,0 | 7.190 Nanograms per liter (ng/L) | Standard Deviation 3.8811 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, predose, n=6,1 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, 1 hour, n=6,1 | 0.105 Nanograms per liter (ng/L) | Standard Deviation 0.1663 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, 3 hour, n=6,1 | 0.763 Nanograms per liter (ng/L) | Standard Deviation 0.4804 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, 6 hour, n=6,1 | 1.710 Nanograms per liter (ng/L) | Standard Deviation 1.4719 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 2, n=6,1 | -0.005 Nanograms per liter (ng/L) | Standard Deviation 0.2436 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 3, predose, n=6,1 | 0.040 Nanograms per liter (ng/L) | Standard Deviation 0.3347 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 3, 1 hour, n=6,0 | 0.670 Nanograms per liter (ng/L) | Standard Deviation 1.0153 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 3, 3 hour, n=6,0 | 0.065 Nanograms per liter (ng/L) | Standard Deviation 0.3896 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 3, 6 hour, n=6,0 | 0.002 Nanograms per liter (ng/L) | Standard Deviation 0.0041 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 4, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 5, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day -2, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 1, predose, n=6,0 | 0.002 Nanograms per liter (ng/L) | Standard Deviation 0.0041 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 1, 1 hour, n=6,0 | 0.612 Nanograms per liter (ng/L) | Standard Deviation 0.8293 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 1, 3 hour, n=6,0 | 1.132 Nanograms per liter (ng/L) | Standard Deviation 1.1748 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 1, 6 hour, n=6,0 | 0.785 Nanograms per liter (ng/L) | Standard Deviation 0.5189 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 2, n=6,0 | 0.012 Nanograms per liter (ng/L) | Standard Deviation 0.2757 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 3, predose, n=6,0 | 0.233 Nanograms per liter (ng/L) | Standard Deviation 0.5618 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 3, 1 hour, n=6,0 | 0.775 Nanograms per liter (ng/L) | Standard Deviation 1.1274 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 3, 3 hour, n=6,0 | 0.782 Nanograms per liter (ng/L) | Standard Deviation 0.8451 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 3, 6 hour, n=6,0 | 0.015 Nanograms per liter (ng/L) | Standard Deviation 0.0367 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 4, n=6,0 | -0.005 Nanograms per liter (ng/L) | Standard Deviation 0.0122 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 2, Day 5, n=6,0 | 0.110 Nanograms per liter (ng/L) | Standard Deviation 0.2122 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day -2, n=5,0 | 0.032 Nanograms per liter (ng/L) | Standard Deviation 0.3422 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 1, predose, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 1, 1 hour, n=6,0 | 0.228 Nanograms per liter (ng/L) | Standard Deviation 0.2328 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 1, 3 hour, n=6,0 | 1.185 Nanograms per liter (ng/L) | Standard Deviation 1.1559 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 1, 6 hour, n=6,0 | 0.495 Nanograms per liter (ng/L) | Standard Deviation 0.6641 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 2, n=5,0 | -0.080 Nanograms per liter (ng/L) | Standard Deviation 0.1789 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 3, predose, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 3, 1 hour, n=6,0 | 0.450 Nanograms per liter (ng/L) | Standard Deviation 0.6048 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 3, 3 hour, n=6,0 | 0.322 Nanograms per liter (ng/L) | Standard Deviation 0.5322 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 3, 6 hour, n=6,0 | 0.092 Nanograms per liter (ng/L) | Standard Deviation 0.1542 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 4, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 3, Day 5, n=6,0 | -0.067 Nanograms per liter (ng/L) | Standard Deviation 0.1633 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day -2, n=5,0 | -0.080 Nanograms per liter (ng/L) | Standard Deviation 0.1789 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 1, predose, n=5,0 | -0.080 Nanograms per liter (ng/L) | Standard Deviation 0.1789 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 1, 1 hour, n=5,0 | 0.758 Nanograms per liter (ng/L) | Standard Deviation 1.4466 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 1, 3 hour, n=5,0 | 3.868 Nanograms per liter (ng/L) | Standard Deviation 6.3123 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 1, 6 hour, n=5,0 | 0.868 Nanograms per liter (ng/L) | Standard Deviation 0.9281 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 2, n=5,0 | -0.080 Nanograms per liter (ng/L) | Standard Deviation 0.1789 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 3, predose, n=5,0 | 0.022 Nanograms per liter (ng/L) | Standard Deviation 0.0492 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 3, 1 hour, n=5,0 | 0.808 Nanograms per liter (ng/L) | Standard Deviation 1.0592 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 3, 3 hour, n=5,0 | 0.598 Nanograms per liter (ng/L) | Standard Deviation 0.6549 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 3, 6 hour, n=5,0 | 0.184 Nanograms per liter (ng/L) | Standard Deviation 0.4284 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 4, n=5,0 | -0.080 Nanograms per liter (ng/L) | Standard Deviation 0.1789 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 4, Day 5, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day -2, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 1, predose, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 1, 1 hour, n=4,0 | 2.485 Nanograms per liter (ng/L) | Standard Deviation 4.8507 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 1, 3 hour, n=4,0 | 3.828 Nanograms per liter (ng/L) | Standard Deviation 6.5828 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 1, 6 hour, n=4,0 | 1.120 Nanograms per liter (ng/L) | Standard Deviation 1.5607 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 2, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 3, 1 hour, n=4,0 | 0.950 Nanograms per liter (ng/L) | Standard Deviation 0.933 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 3, 3 hour, n=4,0 | 1.060 Nanograms per liter (ng/L) | Standard Deviation 0.9783 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 3, 6 hour, n=4,0 | 0.663 Nanograms per liter (ng/L) | Standard Deviation 0.6663 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 4, n=4,0 | 0.210 Nanograms per liter (ng/L) | Standard Deviation 0.4267 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 5, Day 5, n=4,0 | 0.025 Nanograms per liter (ng/L) | Standard Deviation 0.05 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day -2, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 1, predose, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 1, 1 hour, n=4,0 | 0.333 Nanograms per liter (ng/L) | Standard Deviation 0.9506 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 1, 3 hour, n=4,0 | 1.738 Nanograms per liter (ng/L) | Standard Deviation 2.5365 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 1, 6 hour, n=4,0 | 1.418 Nanograms per liter (ng/L) | Standard Deviation 1.7245 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 2, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 3, predose, n=4,0 | 0.015 Nanograms per liter (ng/L) | Standard Deviation 0.03 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 3, 1 hour, n=4,0 | 0.753 Nanograms per liter (ng/L) | Standard Deviation 1.4004 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 3, 3 hour, n=4,0 | 0.675 Nanograms per liter (ng/L) | Standard Deviation 1.1466 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 3, 6 hour, n=4,0 | 0.220 Nanograms per liter (ng/L) | Standard Deviation 0.2723 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 4, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 0.2 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 6, Day 5, n=4,0 | 0.023 Nanograms per liter (ng/L) | Standard Deviation 0.045 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, predose, n=6,1 | 0.055 Nanograms per liter (ng/L) | Standard Deviation 0.4378 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, 1 hour, n=6,1 | 0.007 Nanograms per liter (ng/L) | Standard Deviation 0.7159 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, 3 hour, n=6,1 | -0.180 Nanograms per liter (ng/L) | Standard Deviation 0.743 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, 6 hour, n=6,1 | -0.132 Nanograms per liter (ng/L) | Standard Deviation 0.8145 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 2, n=6,1 | 1.920 Nanograms per liter (ng/L) | Standard Deviation 1.5379 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 3, predose, n=6,1 | 1.453 Nanograms per liter (ng/L) | Standard Deviation 1.3405 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 3, 3 hour, n=6,0 | 0.797 Nanograms per liter (ng/L) | Standard Deviation 1.0229 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 3, 6 hour, n=6,0 | 0.460 Nanograms per liter (ng/L) | Standard Deviation 0.9373 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 4, n=6,0 | 1.088 Nanograms per liter (ng/L) | Standard Deviation 1.2874 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 5, n=6,0 | 1.577 Nanograms per liter (ng/L) | Standard Deviation 1.5915 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day -2, n=6,0 | 0.167 Nanograms per liter (ng/L) | Standard Deviation 0.9735 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 1, predose, n=6,0 | 0.233 Nanograms per liter (ng/L) | Standard Deviation 0.8351 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 1, 1 hour, n=6,0 | 0.133 Nanograms per liter (ng/L) | Standard Deviation 1.0259 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 1, 3 hour, n=6,0 | 0.015 Nanograms per liter (ng/L) | Standard Deviation 1.094 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 1, 6 hour, n=6,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 1.2625 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 2, n=6,0 | 1.523 Nanograms per liter (ng/L) | Standard Deviation 1.6646 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 3, predose, n=6,0 | 2.143 Nanograms per liter (ng/L) | Standard Deviation 1.5642 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 3, 1 hour, n=6,0 | 1.682 Nanograms per liter (ng/L) | Standard Deviation 1.3855 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 3, 3 hour, n=6,0 | 1.133 Nanograms per liter (ng/L) | Standard Deviation 0.997 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 3, 6 hour, n=6,0 | 0.503 Nanograms per liter (ng/L) | Standard Deviation 1.0718 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 4, n=6,0 | 1.397 Nanograms per liter (ng/L) | Standard Deviation 2.1712 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 2, Day 5, n=6,0 | 1.968 Nanograms per liter (ng/L) | Standard Deviation 1.456 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day -2, n=5,0 | 0.098 Nanograms per liter (ng/L) | Standard Deviation 1.2163 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 1, predose, n=6,0 | 0.497 Nanograms per liter (ng/L) | Standard Deviation 0.965 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 1, 1 hour, n=6,0 | -0.297 Nanograms per liter (ng/L) | Standard Deviation 0.9572 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 1, 3 hour, n=6,0 | -0.198 Nanograms per liter (ng/L) | Standard Deviation 0.9246 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 1, 6 hour, n=6,0 | -0.167 Nanograms per liter (ng/L) | Standard Deviation 1.2317 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 2, n=5,0 | 0.446 Nanograms per liter (ng/L) | Standard Deviation 1.1212 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 3, predose, n=6,0 | 1.267 Nanograms per liter (ng/L) | Standard Deviation 1.1583 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 3, 1 hour, n=6,0 | 0.513 Nanograms per liter (ng/L) | Standard Deviation 1.1234 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 3, 3 hour, n=6,0 | 0.128 Nanograms per liter (ng/L) | Standard Deviation 1.0706 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 3, 6 hour, n=6,0 | 0.233 Nanograms per liter (ng/L) | Standard Deviation 1.2605 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day -2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 2, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 3, 1 hour, n=6,0 | 0.293 Nanograms per liter (ng/L) | Standard Deviation 0.7185 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 3, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 1, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 1, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 1, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 1, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 3, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 3, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 3, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 3, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 4, n=5,0 | 0.504 Nanograms per liter (ng/L) | Standard Deviation 1.127 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 4, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 5, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 6, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, predose, n=6,1 | 0.275 Nanograms per liter (ng/L) | Standard Deviation 0.4711 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, 1 hour, n=6,1 | -0.080 Nanograms per liter (ng/L) | Standard Deviation 0.7723 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, 3 hour, n=6,1 | -0.727 Nanograms per liter (ng/L) | Standard Deviation 1.2035 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, 6 hour, n=6,1 | -1.077 Nanograms per liter (ng/L) | Standard Deviation 1.2511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 2, n=6,1 | 6.278 Nanograms per liter (ng/L) | Standard Deviation 6.3567 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 3, predose, n=6,1 | 7.688 Nanograms per liter (ng/L) | Standard Deviation 8.8639 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 3, 1 hour, n=6,0 | 6.857 Nanograms per liter (ng/L) | Standard Deviation 10.5934 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 3, 3 hour, n=6,0 | 0.827 Nanograms per liter (ng/L) | Standard Deviation 3.579 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 3, 6 hour, n=6,0 | 0.932 Nanograms per liter (ng/L) | Standard Deviation 5.5637 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 4, n=6,0 | 5.453 Nanograms per liter (ng/L) | Standard Deviation 3.6039 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 5, n=6,0 | 3.245 Nanograms per liter (ng/L) | Standard Deviation 3.3934 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day -2, n=6,0 | 0.393 Nanograms per liter (ng/L) | Standard Deviation 0.525 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 1, predose, n=6,0 | 0.632 Nanograms per liter (ng/L) | Standard Deviation 1.2026 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 1, 1 hour, n=6,0 | 0.025 Nanograms per liter (ng/L) | Standard Deviation 0.7117 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 1, 3 hour, n=6,0 | -0.860 Nanograms per liter (ng/L) | Standard Deviation 1.0909 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 1, 6 hour, n=6,0 | -0.282 Nanograms per liter (ng/L) | Standard Deviation 1.7148 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 2, n=6,0 | 21.590 Nanograms per liter (ng/L) | Standard Deviation 27.1214 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 3, predose, n=6,0 | 11.365 Nanograms per liter (ng/L) | Standard Deviation 11.414 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 3, 1 hour, n=6,0 | 7.517 Nanograms per liter (ng/L) | Standard Deviation 8.6084 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 3, 3 hour, n=6,0 | 3.460 Nanograms per liter (ng/L) | Standard Deviation 5.0176 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 3, 6 hour, n=6,0 | 0.723 Nanograms per liter (ng/L) | Standard Deviation 4.5392 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 4, n=6,0 | 4.580 Nanograms per liter (ng/L) | Standard Deviation 5.9326 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 2, Day 5, n=6,0 | 6.395 Nanograms per liter (ng/L) | Standard Deviation 5.28 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day -2, n=5,0 | 0.148 Nanograms per liter (ng/L) | Standard Deviation 0.8211 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 1, predose, n=6,0 | 0.782 Nanograms per liter (ng/L) | Standard Deviation 1.5023 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 1, 1 hour, n=6,0 | 0.268 Nanograms per liter (ng/L) | Standard Deviation 1.4865 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 1, 3 hour, n=6,0 | 0.062 Nanograms per liter (ng/L) | Standard Deviation 2.5899 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 1, 6 hour, n=6,0 | -0.918 Nanograms per liter (ng/L) | Standard Deviation 1.2591 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 2, n=5,0 | 17.608 Nanograms per liter (ng/L) | Standard Deviation 29.2558 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 3, predose, n=6,0 | 11.872 Nanograms per liter (ng/L) | Standard Deviation 8.7413 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 3, 1 hour, n=6,0 | 5.835 Nanograms per liter (ng/L) | Standard Deviation 3.8271 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 3, 3 hour, n=6,0 | 1.742 Nanograms per liter (ng/L) | Standard Deviation 1.9174 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 3, 6 hour, n=6,0 | 0.063 Nanograms per liter (ng/L) | Standard Deviation 2.2072 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 4, n=6,0 | 4.667 Nanograms per liter (ng/L) | Standard Deviation 6.9875 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 3, Day 5, n=6,0 | 5.570 Nanograms per liter (ng/L) | Standard Deviation 2.6004 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day -2, n=5,0 | 0.892 Nanograms per liter (ng/L) | Standard Deviation 0.8423 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 1, predose, n=5,0 | 1.486 Nanograms per liter (ng/L) | Standard Deviation 0.8702 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 1, 1 hour, n=5,0 | 0.926 Nanograms per liter (ng/L) | Standard Deviation 0.7103 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 1, 3 hour, n=5,0 | -0.026 Nanograms per liter (ng/L) | Standard Deviation 0.1599 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 1, 6 hour, n=5,0 | -1.028 Nanograms per liter (ng/L) | Standard Deviation 1.3685 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 2, n=5,0 | 5.720 Nanograms per liter (ng/L) | Standard Deviation 11.3851 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 3, predose, n=5,0 | 10.924 Nanograms per liter (ng/L) | Standard Deviation 6.537 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 3, 1 hour, n=5,0 | 4.486 Nanograms per liter (ng/L) | Standard Deviation 2.042 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 3, 3 hour, n=5,0 | 1.446 Nanograms per liter (ng/L) | Standard Deviation 1.5368 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 3, 6 hour, n=5,0 | -0.116 Nanograms per liter (ng/L) | Standard Deviation 1.7948 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 4, n=5,0 | 5.756 Nanograms per liter (ng/L) | Standard Deviation 6.8645 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 4, Day 5, n=4,0 | 4.388 Nanograms per liter (ng/L) | Standard Deviation 3.7765 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day -2, n=4,0 | 0.027 Nanograms per liter (ng/L) | Standard Deviation 0.8164 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 1, predose, n=4,0 | 0.865 Nanograms per liter (ng/L) | Standard Deviation 0.9927 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 1, 1 hour, n=4,0 | -0.007 Nanograms per liter (ng/L) | Standard Deviation 1.3219 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 5, Day 1, 3 hour, n=4,0 | -0.423 Nanograms per liter (ng/L) | Standard Deviation 1.5816 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 4, n=6,0 | 0.585 Nanograms per liter (ng/L) | Standard Deviation 1.6017 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 3, Day 5, n=6,0 | 0.997 Nanograms per liter (ng/L) | Standard Deviation 1.3819 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day -2, n=5,0 | -0.208 Nanograms per liter (ng/L) | Standard Deviation 0.5949 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 1, predose, n=5,0 | -0.214 Nanograms per liter (ng/L) | Standard Deviation 0.8527 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 1, 1 hour, n=5,0 | 0.160 Nanograms per liter (ng/L) | Standard Deviation 1.5494 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 1, 3 hour, n=5,0 | 0.218 Nanograms per liter (ng/L) | Standard Deviation 1.5011 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 1, 6 hour, n=5,0 | -0.412 Nanograms per liter (ng/L) | Standard Deviation 1.1373 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 2, n=5,0 | -0.122 Nanograms per liter (ng/L) | Standard Deviation 0.6977 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 3, predose, n=5,0 | 0.606 Nanograms per liter (ng/L) | Standard Deviation 0.5265 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 3, 1 hour, n=5,0 | 0.100 Nanograms per liter (ng/L) | Standard Deviation 0.5074 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 3, 3 hour, n=5,0 | 0.098 Nanograms per liter (ng/L) | Standard Deviation 0.7172 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 3, 6 hour, n=5,0 | -0.702 Nanograms per liter (ng/L) | Standard Deviation 0.5368 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 4, n=5,0 | -0.270 Nanograms per liter (ng/L) | Standard Deviation 0.7576 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 4, Day 5, n=4,0 | 0.095 Nanograms per liter (ng/L) | Standard Deviation 0.4456 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day -2, n=4,0 | -0.350 Nanograms per liter (ng/L) | Standard Deviation 0.5814 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 1, predose, n=4,0 | -0.320 Nanograms per liter (ng/L) | Standard Deviation 0.6703 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 1, 1 hour, n=4,0 | -0.130 Nanograms per liter (ng/L) | Standard Deviation 1.2227 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 1, 3 hour, n=4,0 | -0.055 Nanograms per liter (ng/L) | Standard Deviation 1.0728 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 1, 6 hour, n=4,0 | -0.513 Nanograms per liter (ng/L) | Standard Deviation 1.1003 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 2, n=4,0 | -0.498 Nanograms per liter (ng/L) | Standard Deviation 0.9752 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 3, predose, n=4,0 | 0.147 Nanograms per liter (ng/L) | Standard Deviation 0.8951 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 3, 1 hour, n=4,0 | -0.188 Nanograms per liter (ng/L) | Standard Deviation 0.7406 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 3, 3 hour, n=4,0 | -0.378 Nanograms per liter (ng/L) | Standard Deviation 0.9306 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 3, 6 hour, n=4,0 | -0.630 Nanograms per liter (ng/L) | Standard Deviation 0.7857 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 4, n=4,0 | -0.100 Nanograms per liter (ng/L) | Standard Deviation 1.0725 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 5, Day 5, n=4,0 | 0.168 Nanograms per liter (ng/L) | Standard Deviation 0.3909 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day -2, n=4,0 | -0.428 Nanograms per liter (ng/L) | Standard Deviation 1.3664 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 1, predose, n=4,0 | -0.238 Nanograms per liter (ng/L) | Standard Deviation 1.3158 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 1, 1 hour, n=4,0 | -0.303 Nanograms per liter (ng/L) | Standard Deviation 1.3853 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 1, 3 hour, n=4,0 | -0.145 Nanograms per liter (ng/L) | Standard Deviation 1.8684 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 1, 6 hour, n=4,0 | -0.500 Nanograms per liter (ng/L) | Standard Deviation 1.402 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 2, n=4,0 | -0.000 Nanograms per liter (ng/L) | Standard Deviation 1.3253 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 3, 1 hour, n=4,0 | -0.195 Nanograms per liter (ng/L) | Standard Deviation 1.6007 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 3, 3 hour, n=4,0 | -0.385 Nanograms per liter (ng/L) | Standard Deviation 1.4669 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 6, Day 5, n=4,0 | 0.322 Nanograms per liter (ng/L) | Standard Deviation 1.2795 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, predose, n=6,1 | 0.075 Nanograms per liter (ng/L) | Standard Deviation 1.6224 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, 1 hour, n=6,1 | -1.373 Nanograms per liter (ng/L) | Standard Deviation 2.1255 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, 3 hour, n=6,1 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, 6 hour, n=6,1 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 2, n=6,1 | 1.713 Nanograms per liter (ng/L) | Standard Deviation 7.5955 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 3, predose, n=6,1 | 17.122 Nanograms per liter (ng/L) | Standard Deviation 27.398 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 3, 1 hour, n=6,0 | 12.118 Nanograms per liter (ng/L) | Standard Deviation 22.0807 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 3, 3 hour, n=6,0 | 7.150 Nanograms per liter (ng/L) | Standard Deviation 18.4949 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 3, 6 hour, n=6,0 | 0.538 Nanograms per liter (ng/L) | Standard Deviation 8.5114 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 4, n=6,0 | 3.242 Nanograms per liter (ng/L) | Standard Deviation 12.2847 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 5, n=6,0 | 19.502 Nanograms per liter (ng/L) | Standard Deviation 38.3215 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day -2, n=6,0 | -1.045 Nanograms per liter (ng/L) | Standard Deviation 3.4175 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 1, predose, n=6,0 | 0.452 Nanograms per liter (ng/L) | Standard Deviation 3.5018 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 1, 1 hour, n=6,0 | 0.145 Nanograms per liter (ng/L) | Standard Deviation 3.218 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 1, 3 hour, n=6,0 | -1.833 Nanograms per liter (ng/L) | Standard Deviation 1.3991 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 1, 6 hour, n=6,0 | -3.072 Nanograms per liter (ng/L) | Standard Deviation 2.6378 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 2, n=6,0 | -2.660 Nanograms per liter (ng/L) | Standard Deviation 3.5043 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 3, predose, n=6,0 | -1.045 Nanograms per liter (ng/L) | Standard Deviation 2.226 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 3, 1 hour, n=6,0 | -1.580 Nanograms per liter (ng/L) | Standard Deviation 2.5672 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 3, 3 hour, n=6,0 | -2.473 Nanograms per liter (ng/L) | Standard Deviation 2.5631 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 3, 6 hour, n=6,0 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 4, n=6,0 | -2.572 Nanograms per liter (ng/L) | Standard Deviation 3.404 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 2, Day 5, n=6,0 | -1.993 Nanograms per liter (ng/L) | Standard Deviation 2.8977 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day -2, n=5,0 | -2.190 Nanograms per liter (ng/L) | Standard Deviation 3.9839 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 1, predose, n=6,0 | -1.035 Nanograms per liter (ng/L) | Standard Deviation 4.4739 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 1, 1 hour, n=6,0 | -2.180 Nanograms per liter (ng/L) | Standard Deviation 3.8365 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 1, 3 hour, n=6,0 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 1, 6 hour, n=6,0 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 2, n=5,0 | -2.936 Nanograms per liter (ng/L) | Standard Deviation 3.7855 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 3, predose, n=6,0 | -2.948 Nanograms per liter (ng/L) | Standard Deviation 2.3737 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 3, 1 hour, n=6,0 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 3, 3 hour, n=6,0 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 3, 6 hour, n=6,0 | -3.298 Nanograms per liter (ng/L) | Standard Deviation 3.1409 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 4, n=6,0 | -3.048 Nanograms per liter (ng/L) | Standard Deviation 3.1886 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 3, Day 5, n=6,0 | -2.752 Nanograms per liter (ng/L) | Standard Deviation 3.2989 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day -2, n=5,0 | 0.298 Nanograms per liter (ng/L) | Standard Deviation 5.3631 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 1, predose, n=5,0 | -0.760 Nanograms per liter (ng/L) | Standard Deviation 4.229 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 1, 1 hour, n=5,0 | -1.240 Nanograms per liter (ng/L) | Standard Deviation 4.3736 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 1, 3 hour, n=5,0 | -2.778 Nanograms per liter (ng/L) | Standard Deviation 3.957 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 1, 6 hour, n=5,0 | -3.274 Nanograms per liter (ng/L) | Standard Deviation 3.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 2, n=5,0 | -3.274 Nanograms per liter (ng/L) | Standard Deviation 3.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 3, predose, n=5,0 | -2.836 Nanograms per liter (ng/L) | Standard Deviation 2.6051 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 3, 1 hour, n=5,0 | -3.274 Nanograms per liter (ng/L) | Standard Deviation 3.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 3, 3 hour, n=5,0 | -3.274 Nanograms per liter (ng/L) | Standard Deviation 3.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 3, 6 hour, n=5,0 | -3.274 Nanograms per liter (ng/L) | Standard Deviation 3.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 4, n=5,0 | -3.274 Nanograms per liter (ng/L) | Standard Deviation 3.511 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 4, Day 5, n=4,0 | -2.910 Nanograms per liter (ng/L) | Standard Deviation 3.1667 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day -2, n=4,0 | -0.930 Nanograms per liter (ng/L) | Standard Deviation 3.548 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 1, predose, n=4,0 | -1.328 Nanograms per liter (ng/L) | Standard Deviation 2.1878 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 1, 1 hour, n=4,0 | -1.423 Nanograms per liter (ng/L) | Standard Deviation 1.9828 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 1, 3 hour, n=4,0 | -2.725 Nanograms per liter (ng/L) | Standard Deviation 2.823 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 1, 6 hour, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 2, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 3, predose, n=4,0 | 0.753 Nanograms per liter (ng/L) | Standard Deviation 4.9155 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 3, 1 hour, n=4,0 | 0.203 Nanograms per liter (ng/L) | Standard Deviation 4.5195 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 3, 3 hour, n=4,0 | -1.388 Nanograms per liter (ng/L) | Standard Deviation 4.8505 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 3, 6 hour, n=4,0 | -2.838 Nanograms per liter (ng/L) | Standard Deviation 4.4804 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 4, n=4,0 | -1.653 Nanograms per liter (ng/L) | Standard Deviation 6.0355 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 5, Day 5, n=4,0 | -0.615 Nanograms per liter (ng/L) | Standard Deviation 2.9091 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day -2, n=4,0 | -2.625 Nanograms per liter (ng/L) | Standard Deviation 4.4662 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 1, predose, n=4,0 | -2.668 Nanograms per liter (ng/L) | Standard Deviation 4.4299 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 1, 1 hour, n=4,0 | -2.823 Nanograms per liter (ng/L) | Standard Deviation 4.3091 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 1, 3 hour, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 1, 6 hour, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 2, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 3, predose, n=4,0 | -1.988 Nanograms per liter (ng/L) | Standard Deviation 5.0857 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 3, 1 hour, n=4,0 | -3.018 Nanograms per liter (ng/L) | Standard Deviation 4.1848 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 3, 3 hour, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 3, 6 hour, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 4, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 6, Day 5, n=4,0 | -3.373 Nanograms per liter (ng/L) | Standard Deviation 4.0462 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day -2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 2, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 3, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 1, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 1, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 1, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 1, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 3, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 3, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 3, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 3, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 4, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 4, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 5, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 6, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day -2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 2, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 3, predose, n=6,0 | 0.333 Nanograms per liter (ng/L) | Standard Deviation 0.8165 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 3, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 1, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 1, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 1, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 1, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 3, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 3, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 3, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 3, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 4, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 4, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 3, 1 hour, n=4,0 | 0.283 Nanograms per liter (ng/L) | Standard Deviation 0.565 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 5, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 4, n=4,0 | 0.488 Nanograms per liter (ng/L) | Standard Deviation 0.975 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 6, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day -2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 2, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 3, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 3, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day -2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 1, predose, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 1, 1 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 1, 3 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 1, 6 hour, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 4, Day 2, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 5, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 6, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 3, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 3, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 4, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 5, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day -2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 1, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 1, 1 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 1, 3 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 1, 6 hour, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 2, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 2, Day 3, predose, n=6,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day -2, n=6,0 | 7.848 Nanograms per liter (ng/L) | Standard Deviation 12.9271 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 2, Day 1, predose, n=6,0 | 4.920 Nanograms per liter (ng/L) | Standard Deviation 8.3853 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 4, n=5,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 4, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 5, Day 5, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day -2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 1, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 1, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 1, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 1, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 2, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 3, predose, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 3, 1 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 3, 3 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 3, 6 hour, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 6, Day 4, n=4,0 | 0.000 Nanograms per liter (ng/L) | Standard Deviation 0 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, 6 hour, n=6,1 | 8.350 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, 1 hour, n=6,1 | 8.580 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 3, predose, n=6,1 | 16.980 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, 3 hour, n=6,1 | 5.260 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 1, 6 hour, n=6,1 | 6.020 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 2, n=6,1 | 1.150 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-10, Session 1, Day 3, predose, n=6,1 | 1.280 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-1 beta, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, predose, n=6,1 | 0.320 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, 1 hour, n=6,1 | 0.450 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, 1 hour, n=6,1 | 0.100 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, 3 hour, n=6,1 | 0.880 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, predose, n=6,1 | 1.860 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 1, 6 hour, n=6,1 | 2.300 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 2, n=6,1 | 5.130 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | TNF, Session 1, Day 3, predose, n=6,1 | 3.010 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 3, predose, n=6,1 | 9.350 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 2, n=6,1 | 1.930 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | INF gamma, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, 3 hour, n=6,1 | 0.480 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-2, Session 1, Day 3, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 2, n=6,1 | 12.720 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 1, 6 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-8, Session 1, Day 1, predose, n=6,1 | 1.140 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-4, Session 1, Day 2, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, 3 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-13, Session 1, Day 1, predose, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 1, 6 hour, n=6,1 | 2.880 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-12, Session 1, Day 1, 1 hour, n=6,1 | 0.000 Nanograms per liter (ng/L) | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Plasma Cytokines Over Time | IL-6, Session 1, Day 2, n=6,1 | 29.030 Nanograms per liter (ng/L) | — |
Secondary
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
E/e' ratio was measured by ECHO at indicated time points. It had 2 separate measurements: lateral and septal. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, 8 Week follow-up, n=6,0 | 2.83 Ratio | Standard Deviation 4.236 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 1, Day 24, n=6,1 | -1.55 Ratio | Standard Deviation 2.813 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 5, Day 24, n=4,0 | 4.48 Ratio | Standard Deviation 3.01 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 6, Day 24, n=4,0 | 6.23 Ratio | Standard Deviation 5.917 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, 6 month follow-up, n=4,0 | 4.95 Ratio | Standard Deviation 1.708 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 2, Day 24, n=6,0 | -0.77 Ratio | Standard Deviation 3.555 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 3, Day 24, n=6,0 | 3.20 Ratio | Standard Deviation 2.197 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 4, Day 24, n=5,0 | -0.64 Ratio | Standard Deviation 4.75 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 5, Day 24, n=4,0 | 1.22 Ratio | Standard Deviation 5.134 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 6, Day 24, n=4,0 | 3.25 Ratio | Standard Deviation 2.3 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, 8 Week follow-up, n=6,1 | 0.05 Ratio | Standard Deviation 2.681 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, 6 month follow-up, n=4,0 | -0.58 Ratio | Standard Deviation 4.442 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 1, Day 24, n=6,1 | 0.50 Ratio | Standard Deviation 2.995 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 2, Day 24, n=6,0 | 0.52 Ratio | Standard Deviation 4.64 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 3, Day 24, n=6,0 | 5.33 Ratio | Standard Deviation 5.136 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 4, Day 24, n=5,0 | 2.96 Ratio | Standard Deviation 3.462 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, Session 1, Day 24, n=6,1 | -2.80 Ratio | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Lateral Ratio, 8 Week follow-up, n=6,1 | 2.90 Ratio | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio) | E/e Septal Ratio, Session 1, Day 24, n=6,1 | -2.00 Ratio | — |
Secondary
Change From Baseline in Stroke Volume (SV) by CMR
Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Stroke Volume (SV) by CMR | Session 5, Day 24, n=4,0 | -11.477 Milliliter | Standard Deviation 14.4238 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Stroke Volume (SV) by CMR | Session 3, Day 24, n=6,0 | -1.228 Milliliter | Standard Deviation 24.3834 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Stroke Volume (SV) by CMR | Session 4, Day 24, n=5,0 | -9.766 Milliliter | Standard Deviation 9.7838 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Stroke Volume (SV) by CMR | Session 2, Day 24, n=6,0 | -2.760 Milliliter | Standard Deviation 7.8305 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Stroke Volume (SV) by CMR | 8 Week follow-up, n=6,1 | 2.400 Milliliter | Standard Deviation 19.1252 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in Stroke Volume (SV) by CMR | 6 month follow-up, n=2,0 | -6.160 Milliliter | Standard Deviation 12.0491 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in Stroke Volume (SV) by CMR | 8 Week follow-up, n=6,1 | -6.750 Milliliter | — |
Secondary
Change From Baseline in SV by ECHO
Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | 6 month follow-up, n=4,0 | -4.275 Milliliter | Standard Deviation 9.9743 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | 8 Week follow-up, n=6,1 | -4.343 Milliliter | Standard Deviation 7.3457 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | Session 1, Day 24, n=6,1 | 2.580 Milliliter | Standard Deviation 5.4518 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | Session 2, Day 24, n=6,0 | -1.885 Milliliter | Standard Deviation 4.6569 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | Session 3, Day 24, n=6,0 | -1.398 Milliliter | Standard Deviation 8.0106 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | Session 4, Day 24, n=5,0 | -7.484 Milliliter | Standard Deviation 6.5228 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | Session 5, Day 24, n=4,0 | -9.043 Milliliter | Standard Deviation 9.5173 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Change From Baseline in SV by ECHO | Session 6, Day 24, n=4,0 | -5.095 Milliliter | Standard Deviation 7.1431 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in SV by ECHO | Session 1, Day 24, n=6,1 | -5.640 Milliliter | — |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Change From Baseline in SV by ECHO | 8 Week follow-up, n=6,1 | -6.490 Milliliter | — |
Secondary
Cmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants
Blood samples were planned to be collected for evaluation of PK parameters including Cmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants.'
Time frame: Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)
Population: Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Secondary
Maximum Concentration (Cmax) of GSK2398852
Blood samples were collected for evaluation of Pharmacokinetic (PK) parameters including Cmax at indicated time points. Geometric mean and geometric coefficient of variation of Cmax is presented.
Time frame: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 3, n=6,0 | 222.23 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 44.4 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 6, n=4,0 | 228.51 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 49.73 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 2, n=6,0 | 235.48 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 25.22 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 1, n=6,1 | 86.94 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 31.58 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 4, n=5,0 | 179.82 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 33.87 |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 5, n=4,0 | 185.52 Micrograms per milliliter (ug/mL) | Geometric Coefficient of Variation 34.06 |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Maximum Concentration (Cmax) of GSK2398852 | Session 1, n=6,1 | 88.64 Micrograms per milliliter (ug/mL) | — |
Secondary
Number of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers
Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population. Data was not collected due to project termination.
Secondary
Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies
Skin biopsy samples were collected for histopathological examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies | 2 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies | 0 Participants |
Secondary
Number of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers
Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population. Data was not collected due to project termination.
Secondary
Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies
Skin biopsy samples were collected for immunohistochemical examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented.
Time frame: Up to the end of study (Up to 369 days)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies | 2 Participants |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies | 0 Participants |
Secondary
Time Associated With Cmax (Tmax) of GSK2398852
Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented.
Time frame: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 6, n=4,0 | 54.18 Hour |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 3, n=6,0 | 54.06 Hour |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 1, n=6,1 | 54.18 Hour |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 2, n=6,0 | 54.07 Hour |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 4, n=5,0 | 54.50 Hour |
| Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 5, n=4,0 | 54.28 Hour |
| Group 2: Post-chemotherapy AL Amyloidosis Participants | Time Associated With Cmax (Tmax) of GSK2398852 | Session 1, n=6,1 | 6.1 Hour |
Secondary
Tmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants
Blood samples were planned to be collected for evaluation of PK parameters including Tmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.
Time frame: Day 1: Pre-dose; Day 2: pre-dose and 2 hours post-dose; Day 3: Pre-dose in each session (each session of 24 days)
Population: Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.