Cavernoma, Cavernous Angioma, CCM, Cerebral Cavernous Malformation, Cerebral Cavernous Malformations 1, Cerebral Cavernous Malformations 2, Cerebral Cavernous Malformations 3
Conditions
Keywords
CCM (Cerebral Cavernous Malformations), Dynamic Contrast Enhanced Quantitative Perfusion (DCEQP), Quantitative Susceptibility Mapping (QSM), Cerebral Cavernous Malformation, Cavernoma, Cavernous Angioma
Brief summary
Brain Cavernous Angiomas with Symptomatic Hemorrhage (CASH) are rare, but they exact a heavy burden of neurologic disability from recurrent bleeding, for which there is no proven therapy. This trial readiness project aims to address current critical obstacles in identifying cases at multiple sites, characterizing their relevant features, and measuring their outcome. The timing cannot be more opportune, with therapeutic targets already identified, exceptional collaboration among researchers and with the patient community, and several drugs ready to benefit from a track to clinical testing in the next five years.
Detailed description
The Trial Readiness grant mechanism, funded by NINDS, proposes to address knowledge gaps and establish a research network as infrastructure for future research. This project includes an observational cohort study of 181 patients with an operational goal of demonstrating the feasibility of screening, enrollment rates, baseline disease categorization and follow-up of CASH using common data elements at multiple sites, and to assess the following endpoints for 123 participants enrolled at centers prespecified to do prospective follow-up: (1) the rates of recurrent hemorrhage; (2) the reliability of imaging biomarkers including quantitative susceptibility mapping and permeability measures which have been shown to correlate with lesion activity, and (3) change in functional status during prospective follow-up.
Interventions
None listed
Sponsors
Mayo Clinic
Johns Hopkins University
University of California, San Francisco
National Institute of Neurological Disorders and Stroke (NINDS)
University of Utah
University of New Mexico
Barrow Neurological Institute
University of Chicago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age and older 2. Diagnosed with a brain CA (single or multiple) 3. Had a SH within the past year (with demonstrated new lesional bleeding or hemorrhagic growth on diagnostic studies AND attributable new symptoms) 4. Subject is able to provide informed consent
Exclusion criteria
1. Spinal CA as source of SH 2. Prior brain irradiation 3. Cases where verification of SH with clinical and imaging review cannot be accomplished 4. Prior or planned treatment of the symptomatic lesion (after neurosurgical consultation) To be eligible for Aims 2 and 3, CASH cases enrolled in Aim 1 will be further excluded from follow-up and baseline validation (FUBV) for the following reasons: 1. Contraindication for administration of contrast agent or otherwise unwilling or unable to undergo research MRI studies 2. Pregnant or breastfeeding women 3. Homeless or incarcerated persons, or other reason a subject will be unable/unlikely to return for follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. | 2 year | Number of new bleeds reported during the two year follow-up period in the cohort with CASH. We will assess the change in the number of new symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) | 2 years of follow-up | Change in DCEQP value (vascular permeability) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs |
| Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | 2 years of follow-up | Compare the number of patients with MRS 2 or higher who had prospective symptomatic hemorrhage to those with MRS 2 or higher without prospective symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up periods. The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent. |
| Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | 2 years of follow-up | Percentage of patients with National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ from baseline to year 1 and year 1 to year 2 follow-up periods. NIHSS values range from 0 to 42, with stroke severity categorized as mild (0 to 4), moderate (5 to 14), severe (15 to 24), and very severe (≥25). 4-point decline in ischemic stroke clinical trials typically measures functional decline. |
| Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. | 2 years of follow-up | Median score of European Quality of Life Visual Analogue Scale (EQ-VAS) at baseline, year 1, year 2. The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health. |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | 2 years of follow-up | Proportion of patients with no problems, mild problems, or severe problems in the Mobility domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | 2 years of follow-up | Proportion of patients with no problems, mild problems, or severe problems in the Self-care domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | 2 years of follow-up | Proportion of patients with no problems, mild problems, or severe problems in the Usual activities domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | 2 years of follow-up | Proportion of patients with no problems, mild problems, or severe problems in the Pain / Discomfort domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. |
| Percent Change in QSM Value (Lesional Iron Content) | 2 years of follow-up | Change in QSM value (lesional iron content) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs |
| Median T-score for Anxiety Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Anxiety domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Median T-score for Depression Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Depression domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Median T-score for Fatigue Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Fatigue domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Median T-score for Pain Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Pain domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Median T-score for Sleep Disturbance Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Sleep Disturbance domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Median T-score for Social Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Social domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Median T-score for Physical Function Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 2 years of follow-up | Median T-score for Physical Function domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome. |
| Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | 2 years of follow-up | Proportion of patients with no problems, mild problems, or severe problems in the Anxiety / Depression domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems. |
Countries
United States
Participant flow
Recruitment details
123 participants were enrolled and followed up for 2 years and all results are provided only for these participants.
Participants by arm
| Arm | Count |
|---|---|
| CASH (Cavernous Angiomas With Symptomatic Hemorrhage) The adjudicated definition of CASH (Cavernous Angiomas with Symptomatic Hemorrhage) requires diagnostic evidence of new lesional bleeding or hemorrhagic growth, in association with directly attributable symptoms. | 123 |
| Total | 123 |
Baseline characteristics
| Characteristic | CASH (Cavernous Angiomas With Symptomatic Hemorrhage) |
|---|---|
| Age, Continuous | 43.9 Years STANDARD_DEVIATION 15.3 |
| Alcohol use | 56 Participants |
| Birth control | 2 Participants |
| Body mass index | 26.7 kg/m^2 STANDARD_DEVIATION 5.1 |
| Diastolic blood pressure, mm Hg | 78.3 mmHg STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Familial cavernous malformation syndrome | 48 Participants |
| History of diabetes | 6 Participants |
| History of hypertension | 35 Participants |
| Obstructive sleep apnea | 10 Participants |
| Propranolol | 7 Participants |
| Qualifying Symptomatic Hemorrhage (SH) location: Brainstem Brainstem | 50 Participants |
| Qualifying Symptomatic Hemorrhage (SH) location: Brainstem Cerebellum | 12 Participants |
| Qualifying Symptomatic Hemorrhage (SH) location: Brainstem Lobar | 35 Participants |
| Qualifying Symptomatic Hemorrhage (SH) location: Brainstem Other | 13 Participants |
| Qualifying Symptomatic Hemorrhage (SH) location: Brainstem Thalamus | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 99 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 48 Participants |
| Statin use | 25 Participants |
| Systolic blood pressure, mm Hg | 122.7 mmHg STANDARD_DEVIATION 14.7 |
| Tobacco use | 11 Participants |
| Vitamin D supplementation | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH.
Number of new bleeds reported during the two year follow-up period in the cohort with CASH. We will assess the change in the number of new symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up.
Time frame: 2 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline to Year 1 | Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. | 10 Number of new bleeds |
| Year 1 to Year 2 | Rate of Recurrent Symptomatic Hemorrhage During the Two Year Follow-up Period in Patients With CASH. | 11 Number of new bleeds |
Secondary
Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period.
Compare the number of patients with MRS 2 or higher who had prospective symptomatic hemorrhage to those with MRS 2 or higher without prospective symptomatic hemorrhage from baseline to year 1 and year 1 to year 2 follow-up periods. The mRS is a simple global measure of functional disability. Scores range from 0 (no symptoms) to 6 (death). An mRS score of 0 to 1 is considered a minimal clinical disability, and 0 to 2 is independent.
Time frame: 2 years of follow-up
Population: At year 1, 5 participants with symptomatic hemorrhage were analyzed, and 97 without symptomatic hemorrhage totaling, 102 participants analyzed. At year 2, 7 participants with symptomatic hemorrhage were analyzed, and 62 without symptomatic hemorrhage, totaling 69 participants analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | Symptomatic hemorrhage | 1 Participants |
| Baseline to Year 1 | Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | No symptomatic hemorrhage | 27 Participants |
| Year 1 to Year 2 | Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | Symptomatic hemorrhage | 2 Participants |
| Year 1 to Year 2 | Compare the Number of Patients With MRS 2 or Higher Who Had Prospective Symptomatic Hemorrhage to Those With MRS 2 or Higher Without Prospective Symptomatic Hemorrhage During the 2 Year Follow-up Period. | No symptomatic hemorrhage | 15 Participants |
p-value: 1Chi-squared
Secondary
Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period.
Median score of European Quality of Life Visual Analogue Scale (EQ-VAS) at baseline, year 1, year 2. The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. | 80 score on a scale |
| Year 1 to Year 2 | Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. | 80 score on a scale |
| Year 2 | Median Score of European Quality of Life Visual Analogue Scale (EQ-VAS) During the 2 Year Follow-up Period. | 80 score on a scale |
Secondary
Median T-score for Anxiety Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Anxiety domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Anxiety Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 53.7 T-score |
| Year 1 to Year 2 | Median T-score for Anxiety Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 51.2 T-score |
| Year 2 | Median T-score for Anxiety Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 51.2 T-score |
Secondary
Median T-score for Depression Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Depression domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Depression Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 41.0 T-score |
| Year 1 to Year 2 | Median T-score for Depression Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 41.0 T-score |
| Year 2 | Median T-score for Depression Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 41.0 T-score |
Secondary
Median T-score for Fatigue Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Fatigue domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1, and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Fatigue Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 48.6 T-score |
| Year 1 to Year 2 | Median T-score for Fatigue Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 48.6 T-score |
| Year 2 | Median T-score for Fatigue Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 46.0 T-score |
Secondary
Median T-score for Pain Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Pain domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Pain Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 49.6 T-score |
| Year 1 to Year 2 | Median T-score for Pain Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 49.6 T-score |
| Year 2 | Median T-score for Pain Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 41.6 T-score |
Secondary
Median T-score for Physical Function Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Physical Function domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Physical Function Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 56.9 T-score |
| Year 1 to Year 2 | Median T-score for Physical Function Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 56.9 T-score |
| Year 2 | Median T-score for Physical Function Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 56.9 T-score |
Secondary
Median T-score for Sleep Disturbance Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Sleep Disturbance domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Sleep Disturbance Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 50.5 T-score |
| Year 1 to Year 2 | Median T-score for Sleep Disturbance Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 50.5 T-score |
| Year 2 | Median T-score for Sleep Disturbance Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 50.5 T-score |
Secondary
Median T-score for Social Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period.
Median T-score for Social domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) at baseline, year 1 and year 2. PROMIS-29 (Version 2.0) is a generic health-related quality of life measure including 7 domains (anxiety, depression, fatigue, pain interference, sleep disturbance, and ability to participate in social roles and activities, and physical function).12 Each domain contains questions ranked using a 5-point Likert scale. PROMIS-29 domain scores are converted to T scores and have been standardized to a reference population (mean, 50; SD, 10). Clinically meaningful change is considered to be at least half the SD (5 points). Higher T-score indicates better outcome.
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline to Year 1 | Median T-score for Social Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 51.9 T-score |
| Year 1 to Year 2 | Median T-score for Social Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 51.9 T-score |
| Year 2 | Median T-score for Social Domain of Patient-Reported Outcome Measurement Information System (PROMIS-29) During the 2 Year Follow-up Period. | 64.2 T-score |
Secondary
Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period.
Percentage of patients with National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ from baseline to year 1 and year 1 to year 2 follow-up periods. NIHSS values range from 0 to 42, with stroke severity categorized as mild (0 to 4), moderate (5 to 14), severe (15 to 24), and very severe (≥25). 4-point decline in ischemic stroke clinical trials typically measures functional decline.
Time frame: 2 years of follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 5-14 | 5 Participants |
| Baseline to Year 1 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 0-4 | 117 Participants |
| Baseline to Year 1 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 14+ | 1 Participants |
| Year 1 to Year 2 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 5-14 | 1 Participants |
| Year 1 to Year 2 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 0-4 | 97 Participants |
| Year 1 to Year 2 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 14+ | 0 Participants |
| Year 2 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 0-4 | 61 Participants |
| Year 2 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 14+ | 0 Participants |
| Year 2 | Percentage of Patients With National Institutes of Health Stroke Scale (NIHSS) 0-4, 5-14 and 14+ During the 2 Year Follow-up Period. | NIHSS score 5-14 | 0 Participants |
Secondary
Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability)
Change in DCEQP value (vascular permeability) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline to Year 1 | Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) | 61.62 percent change | Standard Deviation 248.8 |
| Year 1 to Year 2 | Percent Change in Contrast-enhanced Quantitative Perfusion (DCEQP) Value (Vascular Permeability) | 52.45 percent change | Standard Deviation 206.4 |
p-value: 0.3459t-test, 2 sided
Secondary
Percent Change in QSM Value (Lesional Iron Content)
Change in QSM value (lesional iron content) will be presented as a mean value across all participants from baseline to year 1 and year 1 to year 2 follow-up MRIs
Time frame: 2 years of follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline to Year 1 | Percent Change in QSM Value (Lesional Iron Content) | 16.33 percent change | Standard Deviation 74.93 |
| Year 1 to Year 2 | Percent Change in QSM Value (Lesional Iron Content) | 19.61 percent change | Standard Deviation 70.96 |
p-value: 0.033t-test, 2 sided
Secondary
Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period.
Proportion of patients with no problems, mild problems, or severe problems in the Anxiety / Depression domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.
Time frame: 2 years of follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 46 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 72 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 5 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 62 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 38 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 2 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 49 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 0 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Anxiety / Depression Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 19 Participants |
Secondary
Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period.
Proportion of patients with no problems, mild problems, or severe problems in the Mobility domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.
Time frame: 2 years of follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 40 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 83 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe Problems | 0 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 33 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 69 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe Problems | 0 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 44 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe Problems | 0 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Mobility Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 24 Participants |
Secondary
Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period.
Proportion of patients with no problems, mild problems, or severe problems in the Pain / Discomfort domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.
Time frame: 2 years of follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 51 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 63 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 9 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 36 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 63 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 3 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 48 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 1 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Pain / Discomfort Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 19 Participants |
Secondary
Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period.
Proportion of patients with no problems, mild problems, or severe problems in the Self-care domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.
Time frame: 2 years of follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 12 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 111 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 0 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 7 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 95 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 0 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 63 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 0 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Self-care Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 5 Participants |
Secondary
Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period.
Proportion of patients with no problems, mild problems, or severe problems in the Usual activities domain of EQ-5D-3 L will be assessed at baseline, year 1, and year 2 follow-up periods. EQ-5D-3 L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease and includes 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are 3 questions per domain where patients respond if they have no problems, mild, or severe problems.
Time frame: 2 years of follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 50 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 72 Participants |
| Baseline to Year 1 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 1 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 34 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 66 Participants |
| Year 1 to Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 2 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | No problems | 50 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Severe problems | 1 Participants |
| Year 2 | Proportion of Patients With No Problems, Mild Problems, or Severe Problems in the Usual Activities Domain of European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3 L) During the 2 Year Follow-up Period. | Mild problems | 17 Participants |