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| ID | Type | Description | Link |
|---|---|---|---|
| C4411001 | Other Identifier | Alias Study Number |
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This is a rollover study designed to investigate the safety and effectiveness of investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and may, in the Investigator's opinion, derive benefit from continued treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-371797 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-371797, p38 inhibitor, oral | Drug | multiple dose, single schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | In this outcome measure, number of participants with baseline laboratory hematology values as per National Cancer Institute Common Terminology Criteria (NCI-CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes/shift to the worst CTC grades post baseline were presented. Shift data have been reported for hematology parameters: hemoglobin (g/L), platelets (10^9/L), leukocytes (10^9/L), neutrophils (10^9/L), lymphocytes (10^9/L) and eosinophils (10^9/L). Baseline was defined as last non-missing value before the initial administration of study treatment in parent study and worst post-baseline value defined as worst value between first dose of study drug up to the maximum of 282 weeks. Only those categories in which at least 1 participant had data were reported. | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) |
| Number of Participants With Change From Baseline Value in Clinical Laboratory Chemistry Test Results to Worst Value | In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTC grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes/shift to the worst CTC grades post baseline were presented. Shift data have been reported for laboratory parameters: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, international unit per liter (IU/L), albumin, bilirubin, urea nitrogen, calcium, creatinine, glucose, magnesium, protein and phosphate grams per deciliter (g/dL), potassium and sodium, millimol per liter (mmol/L). Baseline was defined as last non-missing value before the initial administration of study treatment in parent study and worst post-baseline value defined as worst value between first dose of study drug up to the maximum of 282 weeks. Only those categories in which at least 1 participant had data were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Six Minute Walk Test (6MWT) Distance at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | 6MWT was the distance that a participant could quickly walk on a flat, hard surface in a period of 6 minutes. Participants were asked to walk a set course of 30 meters for 6 minutes (timed), and the distance walked (in meters) was recorded. Change from baseline in 6MWT distance at specified time points were reported. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38979608 | Derived | Garcia-Pavia P, Palomares JFR, Sinagra G, Barriales-Villa R, Lakdawala NK, Gottlieb RL, Goldberg RI, Elliott P, Lee P, Li H, Angeli FS, Judge DP, MacRae CA; REALM-DCM Investigators. REALM-DCM: A Phase 3, Multinational, Randomized, Placebo-Controlled Trial of ARRY-371797 in Patients With Symptomatic LMNA-Related Dilated Cardiomyopathy. Circ Heart Fail. 2024 Jul;17(7):e011548. doi: 10.1161/CIRCHEARTFAILURE.123.011548. Epub 2024 Jul 9. | |
| 36718638 |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Total 8 participants signed the informed consent form (ICF). All were enrolled into the study and assigned to a study treatment. None of them were screen failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | ARRY-371797 | Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA (Gene encoding the Lamin A/C protein) mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 milligram (mg) twice a day (BID) until treatment discontinuation criteria [withdrawal of consent, unacceptable adverse events (AE) or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | ARRY-371797 | Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 mg BID until treatment discontinuation criteria [withdrawal of consent, unacceptable AE or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
|
Baseline up to 30 days after last dose of study drug (maximum up to 282 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARRY-371797 | Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 mg BID until treatment discontinuation criteria [withdrawal of consent, unacceptable AE or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure acute | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2014 | Dec 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 7, 2017 | Dec 13, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D000083083 | Laminopathies |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| C000592910 | ARRY-371797 |
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| Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) |
| Number of Participants With Abnormal Physical Examination Findings | Physical examination included the assessment of skin, head, ears, eyes, nose, throat, cardiovascular system, abdomen and lungs. Abnormality in physical examination were based on investigator's discretion. | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
| Number of Participants With Abnormalities in Vital Signs | Following vital signs parameters were analyzed using prespecified range of results for signs of clinical significance: systolic blood pressure in millimeters of mercury (mmHg): <90 mmHg and ≥160 mmHg, diastolic blood pressure: <60 mmHg and ≥100 mmHg, heart rate in beats per minute (bpm): <40bpm and >120 bpm, temperature in degree Celsius (C): <36.1 and > 37.2 degree C. | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Following ECG parameters were analyzed using prespecified range of results for signs of clinical significance: heart rate: <40bpm and >120 bpm; QT/QTcF (QT interval corrected using Fridericia's formula) criteria: QT interval >500 ms; QTcF interval >450 ms; or change from baseline in QTcF >30 ms. | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
| Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Left Ventricular End Systolic Index (LVESVI) and Left Ventricular End Diastolic Volume Index (LVEDVI) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVESVI and LVEDVI were echocardiographic assessment of left ventricular remodeling. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Left Ventricular Mass (LVM) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVM is the weight of the left ventricle in grams estimated by echocardiography. For this outcome measure, Baseline is the pre-dose baseline of parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVEF was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Left Ventricular Mass (LVM) to Volume Ratio at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVM divided by the end diastolic volume, estimated by echocardiography. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Right Ventricular End Diastolic Diameter at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | The internal diameter of the right ventricle at the end of diastole, measured by echocardiography. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Right Ventricular Fractional Area at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Right ventricular fractional area change is a measure of global right ventricular systolic function estimated by echocardiography. For this outcome measure, Baseline is the pre-dose baseline of parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in 36-Item Short-Form (SF-36) Health Survey Score at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | The SF-36 health survey is a participant-reported survey to measure participant's health. It is a 36-item questionnaire used to measure 8 various aspects of health (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). The score range for each of the 8 aspects was from 0 (maximum disability) to 100 (no disability), higher scores indicating good health condition. For this analysis, baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Change From Baseline in Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | KCCQ was a 23-item heart failure specific questionnaire quantified into following 10 summary scores: physical limitation score, symptom frequency score, symptom severity score, symptom stability score, total symptoms score, quality of life score, social interference score, self-efficacy score, overall summary score and clinical summary score. These scores ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. For this analysis, baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
| Mean Plasma Concentration of ARRY-371797 and Metabolites (AR00420643, AR00428028, AR00486705) | Plasma concentrations of ARRY-371797 and its metabolites (AR00420643, AR00428028 and AR00486705) was summarized on Day 1, Weeks 12 and 24 at both pre and post dose. | Pre dose and post dose on Day 1, Weeks 12 and 24 |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Meriter Wisconsin Heart | Madison | Wisconsin | 53713 | United States |
| Derived |
| MacRae CA, Taylor MR, Mestroni L, Moses J, Ashley EA, Wheeler MT, Lakdawala NK, Hershberger RE, Sandor V, Saunders ME, Oliver C, Lee PA, Judge DP. Plain Language Summary of Publication of the safety and efficacy of ARRY-371797 in people with dilated cardiomyopathy and a faulty LMNA gene. Future Cardiol. 2023 Feb;19(2):55-63. doi: 10.2217/fca-2022-0099. Epub 2023 Jan 31. |
| 36114020 | Derived | Judge DP, Lakdawala NK, Taylor MRG, Mestroni L, Li H, Oliver C, Angeli FS, Lee PA, MacRae CA. Long-Term Efficacy and Safety of ARRY-371797 (PF-07265803) in Patients With Lamin A/C-Related Dilated Cardiomyopathy. Am J Cardiol. 2022 Nov 15;183:93-98. doi: 10.1016/j.amjcard.2022.08.001. Epub 2022 Sep 13. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| ARRY-371797 |
Participants with symptomatic genetic dilated cardiomyopathy due to a LMNA mutation, and who received ARRY-371797 in the parent study, NCT02057341, were enrolled in this rollover study ARRAY-797-001. Participants received ARRY-371797 at the same dose and schedule they were administered at the end of parent study: ARRY-371797 tablet or capsules 400 mg BID until treatment discontinuation criteria [withdrawal of consent, unacceptable AE or failure to tolerate ARRY-371797, pregnancy or initiation of breastfeeding, lost to follow-up] were met, (up to a maximum of 282 weeks). If participant had tolerability concerns at 400 mg BID, they were down-titrated to 200 mg BID (400 mg total daily dose). If participant had tolerability concerns at 200 mg BID, they were down-titrated to 100 mg BID (200 mg total daily dose). Participants were followed up to 30 days for safety after last dose of study drug. |
|
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| Primary | Number of Participants With Change From Baseline Value in Clinical Laboratory Hematology Test Results to Worst Value | In this outcome measure, number of participants with baseline laboratory hematology values as per National Cancer Institute Common Terminology Criteria (NCI-CTC) grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes/shift to the worst CTC grades post baseline were presented. Shift data have been reported for hematology parameters: hemoglobin (g/L), platelets (10^9/L), leukocytes (10^9/L), neutrophils (10^9/L), lymphocytes (10^9/L) and eosinophils (10^9/L). Baseline was defined as last non-missing value before the initial administration of study treatment in parent study and worst post-baseline value defined as worst value between first dose of study drug up to the maximum of 282 weeks. Only those categories in which at least 1 participant had data were reported. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here, "Number Analyzed" signifies participants evaluable for specific parameter. | Posted | Count of Participants | Participants | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) |
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|
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| Primary | Number of Participants With Change From Baseline Value in Clinical Laboratory Chemistry Test Results to Worst Value | In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTC grade (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) and corresponding changes/shift to the worst CTC grades post baseline were presented. Shift data have been reported for laboratory parameters: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, international unit per liter (IU/L), albumin, bilirubin, urea nitrogen, calcium, creatinine, glucose, magnesium, protein and phosphate grams per deciliter (g/dL), potassium and sodium, millimol per liter (mmol/L). Baseline was defined as last non-missing value before the initial administration of study treatment in parent study and worst post-baseline value defined as worst value between first dose of study drug up to the maximum of 282 weeks. Only those categories in which at least 1 participant had data were reported. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here, "Number Analyzed" signifies participants evaluable for specific parameter. | Posted | Count of Participants | Participants | Baseline, Post-Baseline (anytime from first dose of study drug to maximum duration of up to 282 weeks) |
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| Primary | Number of Participants With Abnormal Physical Examination Findings | Physical examination included the assessment of skin, head, ears, eyes, nose, throat, cardiovascular system, abdomen and lungs. Abnormality in physical examination were based on investigator's discretion. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
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| Primary | Number of Participants With Abnormalities in Vital Signs | Following vital signs parameters were analyzed using prespecified range of results for signs of clinical significance: systolic blood pressure in millimeters of mercury (mmHg): <90 mmHg and ≥160 mmHg, diastolic blood pressure: <60 mmHg and ≥100 mmHg, heart rate in beats per minute (bpm): <40bpm and >120 bpm, temperature in degree Celsius (C): <36.1 and > 37.2 degree C. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
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| Primary | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | Following ECG parameters were analyzed using prespecified range of results for signs of clinical significance: heart rate: <40bpm and >120 bpm; QT/QTcF (QT interval corrected using Fridericia's formula) criteria: QT interval >500 ms; QTcF interval >450 ms; or change from baseline in QTcF >30 ms. | Safety analysis set included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 30 days after last dose of study drug (i.e., maximum up to 282 weeks) |
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| Secondary | Change From Baseline in Six Minute Walk Test (6MWT) Distance at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | 6MWT was the distance that a participant could quickly walk on a flat, hard surface in a period of 6 minutes. Participants were asked to walk a set course of 30 meters for 6 minutes (timed), and the distance walked (in meters) was recorded. Change from baseline in 6MWT distance at specified time points were reported. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set included participants who had at least 1 post-baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Meters | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in Left Ventricular End Systolic Index (LVESVI) and Left Ventricular End Diastolic Volume Index (LVEDVI) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVESVI and LVEDVI were echocardiographic assessment of left ventricular remodeling. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set included participants who had at least 1 post-baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Milliliter per meter square | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in Left Ventricular Mass (LVM) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVM is the weight of the left ventricle in grams estimated by echocardiography. For this outcome measure, Baseline is the pre-dose baseline of parent study. | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Grams | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVEF was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Percentage of EDV | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in Left Ventricular Mass (LVM) to Volume Ratio at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | LVM divided by the end diastolic volume, estimated by echocardiography. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Grams per milliliter | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in Right Ventricular End Diastolic Diameter at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | The internal diameter of the right ventricle at the end of diastole, measured by echocardiography. Baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Centimeter | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in Right Ventricular Fractional Area at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | Right ventricular fractional area change is a measure of global right ventricular systolic function estimated by echocardiography. For this outcome measure, Baseline is the pre-dose baseline of parent study. | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Percentage | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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| Secondary | Change From Baseline in 36-Item Short-Form (SF-36) Health Survey Score at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | The SF-36 health survey is a participant-reported survey to measure participant's health. It is a 36-item questionnaire used to measure 8 various aspects of health (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). The score range for each of the 8 aspects was from 0 (maximum disability) to 100 (no disability), higher scores indicating good health condition. For this analysis, baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
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|
|
| Secondary | Change From Baseline in Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores at Day 1, Weeks 24, 48, 72, 96 and Early Termination Visit | KCCQ was a 23-item heart failure specific questionnaire quantified into following 10 summary scores: physical limitation score, symptom frequency score, symptom severity score, symptom stability score, total symptoms score, quality of life score, social interference score, self-efficacy score, overall summary score and clinical summary score. These scores ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life. For this analysis, baseline was defined as last non-missing value before the initial administration of study treatment in parent study. | Efficacy analysis set was included participants who had at least 1 post-Baseline efficacy evaluation. Here, "Number Analyzed" signifies participants evaluable for specific time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Day 1, Weeks 24, 48, 72, 96 and early termination visit (anytime within the maximum duration of up to 282 weeks) |
|
|
|
| Secondary | Mean Plasma Concentration of ARRY-371797 and Metabolites (AR00420643, AR00428028, AR00486705) | Plasma concentrations of ARRY-371797 and its metabolites (AR00420643, AR00428028 and AR00486705) was summarized on Day 1, Weeks 12 and 24 at both pre and post dose. | Pharmacokinetic (PK) analysis set included all participants who had at least 1 plasma sample with associated PK concentration results. Here, "Number Analyzed" signifies participants evaluable at specific time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre dose and post dose on Day 1, Weeks 12 and 24 |
|
|
|
| 0 |
| 8 |
| 6 |
| 8 |
| 7 |
| 8 |
| Cardiac failure congestive | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Heart transplant | Surgical and medical procedures | MedDRA v23.1 | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| External ear cellulitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA v23.1 | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v23.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
|
| Coronavirus test positive | Investigations | MedDRA v23.1 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA v23.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA v23.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| Hemoglobin: grade 0 (baseline grade) to post baseline grade 3 |
|
|
| Platelets: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Platelets: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Platelets: grade 1 (baseline grade) to post baseline grade 3 |
|
|
| Leukocytes: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Leukocytes: grade 1 (baseline grade) to post baseline grade 1 |
|
|
| Neutrophils: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Neutrophils: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Lymphocytes: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Lymphocytes: grade 0 (baseline grade) to post baseline grade 2 |
|
|
| Lymphocytes: grade 1 (baseline grade) to post baseline grade 2 |
|
|
| Eosinophils: grade 0 (baseline grade) to post baseline grade 0 |
|
|
|
| Alanine aminotransferase: grade 1 (baseline grade) to post baseline grade 1 |
|
|
| Albumin: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Albumin: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Alkaline phosphatase: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Aspartate aminotransferase: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Aspartate aminotransferase: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Aspartate aminotransferase: grade 1 (baseline grade) to post baseline grade 0 |
|
|
| Bilirubin: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Bilirubin: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Bilirubin: grade 0 (baseline grade) to post baseline grade 3 |
|
|
| Urea nitrogen: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Urea nitrogen: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Urea nitrogen: grade 0 (baseline grade) to post baseline grade 3 |
|
|
| Calcium: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Calcium: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Calcium: grade 0 (baseline grade) to post baseline grade 2 |
|
|
| Creatinine: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Creatinine: grade 0 (baseline grade) to post baseline grade 2 |
|
|
| Glucose: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Glucose: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Glucose: grade 0 (baseline grade) to post baseline grade 2 |
|
|
| Glucose: grade 1 (baseline grade) to post baseline grade 0 |
|
|
| Glucose: grade 2 (baseline grade) to post baseline grade 1 |
|
|
| Magnesium: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Phosphate: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Phosphate: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Phosphate: grade 0 (baseline grade) to post baseline grade 3 |
|
|
| Potassium: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Potassium: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Protein: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Protein: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Protein: grade 0 (baseline grade) to post baseline grade 3 |
|
|
| Protein: grade 1 (baseline grade) to post baseline grade 1 |
|
|
| Sodium: grade 0 (baseline grade) to post baseline grade 0 |
|
|
| Sodium: grade 0 (baseline grade) to post baseline grade 1 |
|
|
| Sodium: grade 2 (baseline grade) to post baseline grade 2 |
|
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Early Termination Visit |
|
|
|
| LVESVI: change at Week 24 |
|
|
| LVESVI: change at Week 48 |
|
|
| LVESVI: change at Week 72 |
|
|
| LVESVI: change at Week 96 |
|
|
| LVESVI: change at Early Termination Visit |
|
|
| LVEDVI: Baseline |
|
|
| LVEDVI: change at Day 1 |
|
|
| LVEDVI: change at Week 24 |
|
|
| LVEDVI: change at Week 48 |
|
|
| LVEDVI: change at Week 72 |
|
|
| LVEDVI: change at Week 96 |
|
|
| LVEDVI: change at Early Termination Visit |
|
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Early Termination Visit |
|
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Early Termination Visit |
|
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Early Termination Visit |
|
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Early Termination Visit |
|
|
|
| Change at Week 24 |
|
|
| Change at Week 48 |
|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Early Termination Visit |
|
|
|
| Vitality: change at Week 24 |
|
|
| Vitality: change at Week 48 |
|
|
| Vitality: change at Week 72 |
|
|
| Vitality: change at Week 96 |
|
|
| Vitality: change at Early Termination Visit |
|
|
| Physical functioning: Baseline |
|
|
| Physical functioning: change at Day 1 |
|
|
| Physical functioning: change at Week 24 |
|
|
| Physical functioning: change at Week 48 |
|
|
| Physical functioning: change at Week 72 |
|
|
| Physical functioning: change at Week 96 |
|
|
| Physical functioning: change at Early Termination Visit |
|
|
| Bodily pain: Baseline |
|
|
| Bodily pain: change at Day 1 |
|
|
| Bodily pain: change at Week 24 |
|
|
| Bodily pain: change at Week 48 |
|
|
| Bodily pain: change at Week 72 |
|
|
| Bodily pain: change at Week 96 |
|
|
| Bodily pain: change at Early Termination Visit |
|
|
| General health: Baseline |
|
|
| General health: change at Day 1 |
|
|
| General health: change at Week 24 |
|
|
| General health: change at Week 48 |
|
|
| General health: change at Week 72 |
|
|
| General health: change at Week 96 |
|
|
| General health: change at Early Termination Visit |
|
|
| Role physical: Baseline |
|
|
| Role physical: change at Day 1 |
|
|
| Role physical: change at Week 24 |
|
|
| Role physical: change at Week 48 |
|
|
| Role physical: change at Week 72 |
|
|
| Role physical: change at Week 96 |
|
|
| Role physical: change at Early Termination Visit |
|
|
| Role emotional: Baseline |
|
|
| Role emotional: change at Day 1 |
|
|
| Role emotional: change at Week 24 |
|
|
| Role emotional: change at Week 48 |
|
|
| Role emotional: change at Week 72 |
|
|
| Role emotional: change at Week 96 |
|
|
| Role emotional: change at Early Termination Visit |
|
|
| Social functioning: Baseline |
|
|
| Social functioning: change at Day 1 |
|
|
| Social functioning: change at Week 24 |
|
|
| Social functioning: change at Week 48 |
|
|
| Social functioning: change at Week 72 |
|
|
| Social functioning: change at Week 96 |
|
|
| Social functioning: change at Early Termination Visit |
|
|
| Mental health: Baseline |
|
|
| Mental health: change at Day 1 |
|
|
| Mental health: change at Week 24 |
|
|
| Mental health: change at Week 48 |
|
|
| Mental health: change at Week 72 |
|
|
| Mental health: change at Week 96 |
|
|
| Mental health: change at Early Termination Visit |
|
|
| Mental Classification System (MCS): Baseline |
|
|
| MCS: change at Day 1 |
|
|
| MCS: change at Week 24 |
|
|
| MCS: change at Week 48 |
|
|
| MCS: change at Week 72 |
|
|
| MCS: change at Week 96 |
|
|
| MCS: change at Early Termination Visit |
|
|
| Physical Classification System (PCS): Baseline |
|
|
| PCS: change at Day 1 |
|
|
| PCS: change at Week 24 |
|
|
| PCS: change at Week 48 |
|
|
| PCS: change at Week 72 |
|
|
| PCS: change at Week 96 |
|
|
| PCS: change at Early Termination Visit |
|
|
|
| Physical limitation score: change at Week 24 |
|
|
| Physical limitation score: change at Week 48 |
|
|
| Physical limitation score: change at Week 72 |
|
|
| Physical limitation score: change at Week 96 |
|
|
| Physical limitation score: change at Early Termination Visit |
|
|
| Symptom stability score: Baseline |
|
|
| Symptom stability score: change at Day 1 |
|
|
| Symptom stability score: change at Week 24 |
|
|
| Symptom stability score: change at Week 48 |
|
|
| Symptom stability score: change at Week 72 |
|
|
| Symptom stability score: change at Week 96 |
|
|
| Symptom stability score: change at Early Termination Visit |
|
|
| Symptom frequency score: Baseline |
|
|
| Symptom frequency score: change at Day 1 |
|
|
| Symptom frequency score: change at Week 24 |
|
|
| Symptom frequency score: change at Week 48 |
|
|
| Symptom frequency score: change at Week 72 |
|
|
| Symptom frequency score: change at Week 96 |
|
|
| Symptom frequency score: change at Early Termination Visit |
|
|
| Symptom burden score: Baseline |
|
|
| Symptom burden score: change at Day 1 |
|
|
| Symptom burden score: change at Week 24 |
|
|
| Symptom burden score: change at Week 48 |
|
|
| Symptom burden score: change at Week 72 |
|
|
| Symptom burden score: change at Week 96 |
|
|
| Symptom burden score: change at Early Termination Visit |
|
|
| Total symptom score: Baseline |
|
|
| Total symptom score: change at Day 1 |
|
|
| Total symptom score: change at Week 24 |
|
|
| Total symptom score: change at Week 48 |
|
|
| Total symptom score: change at Week 72 |
|
|
| Total symptom score: change at Week 96 |
|
|
| Total symptom score: change at Early Termination Visit |
|
|
| Self-efficacy score: Baseline |
|
|
| Self-efficacy score: change at Day 1 |
|
|
| Self-efficacy score: change at Week 24 |
|
|
| Self-efficacy score: change at Week 48 |
|
|
| Self-efficacy score: change at Week 72 |
|
|
| Self-efficacy score: change at Week 96 |
|
|
| Self-efficacy score: change at Early Termination Visit |
|
|
| Quality of life score: Baseline |
|
|
| Quality of life score: change at Day 1 |
|
|
| Quality of life score: change at Week 24 |
|
|
| Quality of life score: change at Week 48 |
|
|
| Quality of life score: change at Week 72 |
|
|
| Quality of life score: change at Week 96 |
|
|
| Quality of life score: change at Early Termination Visit |
|
|
| Social limitation score: Baseline |
|
|
| Social limitation score: change at Day 1 |
|
|
| Social limitation score: change at Week 24 |
|
|
| Social limitation score: change at Week 48 |
|
|
| Social limitation score: change at Week 72 |
|
|
| Social limitation score: change at Week 96 |
|
|
| Social limitation score: change at Early Termination Visit |
|
|
| Overall summary score: Baseline |
|
|
| Overall summary score: change at Day 1 |
|
|
| Overall summary score: change at Week 24 |
|
|
| Overall summary score: change at Week 48 |
|
|
| Overall summary score: change at Week 72 |
|
|
| Overall summary score: change at Week 96 |
|
|
| Overall summary score: change at Early Termination Visit |
|
|
| Clinical summary score: Baseline |
|
|
| Clinical summary score: change at Day 1 |
|
|
| Clinical summary score: change at Week 24 |
|
|
| Clinical summary score: change at Week 48 |
|
|
| Clinical summary score: change at Week 72 |
|
|
| Clinical summary score: change at Week 96 |
|
|
| Clinical summary score: change at Early Termination Visit |
|
|
|
| ARRY-371797 Week 12 (Pre-dose) |
|
|
| ARRY-371797 Week 12 (Post-dose) |
|
|
| ARRY-371797 Week 24 (Pre-dose) |
|
|
| ARRY-371797 Week 24 (Post-dose) |
|
|
| AR00420643 Day 1 (Pre-dose) |
|
|
| AR00420643 Day 1 (Post-dose) |
|
|
| AR00420643 Week 12 (Pre-dose) |
|
|
| AR00420643 Week 12 (Post-dose) |
|
|
| AR00420643 Week 24 (Pre-dose) |
|
|
| AR00420643 Week 24 (Post-dose) |
|
|
| AR00428028 Day 1 (Pre-dose) |
|
|
| AR00428028 Day 1 (Post-dose) |
|
|
| AR00428028 Week 12 (Pre-dose) |
|
|
| AR00428028 Week 12 (Post-dose) |
|
|
| AR00428028 Week 24 (Pre-dose) |
|
|
| AR00428028 Week 24 (Post-dose) |
|
|
| AR00486705 Day 1 (Pre-dose) |
|
|
| AR00486705 Day 1 (Post-dose) |
|
|
| AR00486705 Week 12 (Pre-dose) |
|
|
| AR00486705 Week 12 (Post-dose) |
|
|
| AR00486705 Week 24 (Pre-dose) |
|
|
| AR00486705 Week 24 (Post-dose) |
|
|