Alpha1-antitrypsin Deficiency
Conditions
Brief summary
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the safety of long-term administration of ARALAST. Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every 6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to ARALAST, and chemistry panel. Subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the ARALAST package insert.
Interventions
DRUGARALAST Alpha1-Proteinase Inhibitor
Weekly ARALAST infusions for 2 years, dose and mode of administration as prescribed by the physician
Sponsors
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 18 years of age or older * Diagnosis of AAT deficiency associated emphysema * Active prescription for augmentation therapy with ARALAST * On service with Coram (a speciality pharmacy provider) * Signed and dated informed consent
Exclusion criteria
* Clinically significant medical (other than COPD), psychiatric, or cognitive illness that, in the opinion of Coram or the sponsor or the investigator, may compromise subject safety or compliance (such as end stage renal or hepatic or heart disease, or metastatic cancer or any difficulty in communicating over the telephone lines) * Previous treatment with ARALAST (i.e. subjects who had previously received and then discontinued ARALAST augmentation therapy and are now restarting ARALAST will be excluded from the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Baseline to 24 months | SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'General Health (GH)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Vitality (VT)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. |
| HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. |
| HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Baseline to 12 months | SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Baseline to 12 months | SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
| HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months | Screening to ≤ 6 Months | Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | One year prior to baseline to 24 months post-baseline | Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | One year prior to baseline to 24 months post-baseline | Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | Baseline to 24 Months | Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | One year prior to baseline to 24 months post-baseline | Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | Baseline to 24 Months | Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | One year prior to baseline to 24 months post-baseline | Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | One year prior to baseline to 24 months post-baseline | Number of steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Hepatic Chemistry Parameters: Change From Baseline/Screening | Baseline to 24 months | Summary of changes in hepatic (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase) parameters from screening/baseline through each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Baseline to 24 months | Summary of changes in hepatic (total bilirubin) and renal (Blood urea nitrogen (BUN), creatinine) parameters from screening/baseline through each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
| ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | Baseline to 24 Months | All IgG and IgM titers at screening were ≤ 4. A 2-dilution step increase was defined as follows: • The titer at each 6-month visit must be ≥ 4 when the screening titer = 0 • Each 6-month visit titer / screening titer should be ≥ 4. 6 month window periods are: baseline to ≤6 months, \>6 months to ≤12 months, \>12 months to ≤18 months, and \>18 months to ≤24 months |
| Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital' | Baseline to 24 months | Mean LOS during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months) |
Countries
United States
Participant flow
Recruitment details
This was a surveillance study conducted by Coram, Inc., in locations throughout the United States, and supervised by Baxter. Enrollment began in June 2006 and the study was terminated early, in December 2008, due to Aralast being phased out of the market.
Pre-assignment details
127 participants enrolled in the study, of these 126 participated in the health related quality of life (HRQoL) and healthcare resource utilization (HCRU) portion, 61 consented to the blood draw portion, and 66 only consented to the Quality of Life portion
Participants by arm
| Arm | Count |
|---|---|
| Overall Study | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse event - transient | 5 |
| Overall Study | Change to different product | 1 |
| Overall Study | Death | 7 |
| Overall Study | Discontinue Aralast ≥4 consecutive doses | 12 |
| Overall Study | Due to termination of the study | 66 |
| Overall Study | Insurance (homecare provider) change | 1 |
| Overall Study | Liver transplant | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Terminated by sponsor/ homecare provider | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 52.3 years |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Bodily Pain (BP) | 46.368 Scores on a scale STANDARD_DEVIATION 11.116 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) General Health (GH) | 37.351 Scores on a scale STANDARD_DEVIATION 10.12 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Mental Component Score (MCS) | 50.340 Scores on a scale STANDARD_DEVIATION 11.897 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Mental Health (MH) | 47.326 Scores on a scale STANDARD_DEVIATION 11.358 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Physical Component Score (PCS) | 34.150 Scores on a scale STANDARD_DEVIATION 11.263 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Physical Functioning (PF) | 31.612 Scores on a scale STANDARD_DEVIATION 11.678 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Role Limitation Due to Emotional Problems (RE) | 48.474 Scores on a scale STANDARD_DEVIATION 10.687 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Role Limitation Due to Physical Health (RP) | 37.281 Scores on a scale STANDARD_DEVIATION 11.871 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Social Functioning (SF) | 41.699 Scores on a scale STANDARD_DEVIATION 14.069 |
| Health Related Quality of Life (HRQoL): Baseline Assessment SF-36 Health Domain Scores (n=126) Vitality (VT) | 42.279 Scores on a scale STANDARD_DEVIATION 11.209 |
| Region of Enrollment United States | 127 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 97 / 127 |
| serious Total, serious adverse events | 39 / 127 |
Outcome results
Primary
HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months | 46.474 Scores on a scale | Standard Deviation 10.895 |
| Baseline to ≤6 Months | HRQoL 'Bodily Pain (BP)' From Baseline to ≤6 Months | 48.950 Scores on a scale | Standard Deviation 11.579 |
p-value: 0.044Paired t-test
Primary
HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months
SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Baseline to 12 months
Population: Participants with baseline and participating during the period from baseline to ≤12 months data for HRQoL
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Physical Functioning (PF) | 34.822 Scores on a scale | Standard Deviation 11.173 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Role Limitation Due to Physical Health (RP) | 40.539 Scores on a scale | Standard Deviation 11.627 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Bodily Pain (BP) | 47.203 Scores on a scale | Standard Deviation 11.375 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | General Health (GH) | 38.853 Scores on a scale | Standard Deviation 10.197 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Vitality (VT) | 44.646 Scores on a scale | Standard Deviation 11.546 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Social Functioning (SF) | 44.683 Scores on a scale | Standard Deviation 13.864 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Role Limitation Due to Emotional Problems (RE) | 48.403 Scores on a scale | Standard Deviation 11.214 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Mental Health (MH) | 47.365 Scores on a scale | Standard Deviation 11.04 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Physical Component Score (PCS) | 37.346 Scores on a scale | Standard Deviation 10.906 |
| Baseline | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Mental Component Score (MCS) | 50.442 Scores on a scale | Standard Deviation 11.896 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Physical Component Score (PCS) | 37.890 Scores on a scale | Standard Deviation 10.499 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Physical Functioning (PF) | 35.632 Scores on a scale | Standard Deviation 11.251 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Social Functioning (SF) | 47.200 Scores on a scale | Standard Deviation 11.799 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Vitality (VT) | 45.703 Scores on a scale | Standard Deviation 11.516 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Role Limitation Due to Physical Health (RP) | 39.484 Scores on a scale | Standard Deviation 11.615 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Mental Component Score (MCS) | 52.508 Scores on a scale | Standard Deviation 10.354 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Mental Health (MH) | 50.311 Scores on a scale | Standard Deviation 8.962 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Bodily Pain (BP) | 50.227 Scores on a scale | Standard Deviation 11.267 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Role Limitation Due to Emotional Problems (RE) | 48.583 Scores on a scale | Standard Deviation 10.59 |
| Baseline to ≤6 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | General Health (GH) | 39.990 Scores on a scale | Standard Deviation 10.013 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Mental Health (MH) | 49.488 Scores on a scale | Standard Deviation 11.705 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | General Health (GH) | 40.026 Scores on a scale | Standard Deviation 11.72 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Vitality (VT) | 44.742 Scores on a scale | Standard Deviation 11.058 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Social Functioning (SF) | 43.927 Scores on a scale | Standard Deviation 14.384 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Physical Component Score (PCS) | 36.272 Scores on a scale | Standard Deviation 11.238 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Role Limitation Due to Emotional Problems (RE) | 48.942 Scores on a scale | Standard Deviation 12.011 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Physical Functioning (PF) | 34.143 Scores on a scale | Standard Deviation 11.914 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Mental Component Score (MCS) | 51.854 Scores on a scale | Standard Deviation 12.088 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Role Limitation Due to Physical Health (RP) | 38.542 Scores on a scale | Standard Deviation 13.061 |
| >6 Months to ≤12 Months | HRQoL For: PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS: Baseline, Baseline to ≤6 Months, and >6 Months to ≤12 Months | Bodily Pain (BP) | 47.788 Scores on a scale | Standard Deviation 13.139 |
Primary
HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months
SF-36 Scores- baseline thru 24 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Baseline to 24 months
Population: Participants with baseline and participating during the period from baseline to ≤24 months data for HRQoL
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Physical Health (RP) | 43.092 Scores on a scale | Standard Deviation 13.267 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Emotional Problems (RE) | 49.215 Scores on a scale | Standard Deviation 14.077 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Health (MH) | 48.801 Scores on a scale | Standard Deviation 13.404 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Bodily Pain (BP) | 52.036 Scores on a scale | Standard Deviation 13.33 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Component Score (MCS) | 51.510 Scores on a scale | Standard Deviation 14.484 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | General Health (GH) | 38.452 Scores on a scale | Standard Deviation 11.496 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Functioning (PF) | 36.489 Scores on a scale | Standard Deviation 11.174 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Vitality (VT) | 47.036 Scores on a scale | Standard Deviation 11.949 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Social Functioning (SF) | 46.980 Scores on a scale | Standard Deviation 16.418 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Component Score (PCS) | 39.963 Scores on a scale | Standard Deviation 11.722 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Component Score (MCS) | 53.011 Scores on a scale | Standard Deviation 12.441 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Bodily Pain (BP) | 53.988 Scores on a scale | Standard Deviation 11.695 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Component Score (PCS) | 40.480 Scores on a scale | Standard Deviation 11.113 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | General Health (GH) | 40.744 Scores on a scale | Standard Deviation 10.222 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Social Functioning (SF) | 48.538 Scores on a scale | Standard Deviation 12.026 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Emotional Problems (RE) | 49.400 Scores on a scale | Standard Deviation 12.002 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Physical Health (RP) | 42.509 Scores on a scale | Standard Deviation 11.39 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Vitality (VT) | 48.969 Scores on a scale | Standard Deviation 10.116 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Health (MH) | 50.007 Scores on a scale | Standard Deviation 10.686 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Functioning (PF) | 35.988 Scores on a scale | Standard Deviation 10.874 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Component Score (PCS) | 38.287 Scores on a scale | Standard Deviation 12.037 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Vitality (VT) | 49.118 Scores on a scale | Standard Deviation 10.187 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Physical Health (RP) | 40.643 Scores on a scale | Standard Deviation 13.245 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Bodily Pain (BP) | 52.559 Scores on a scale | Standard Deviation 14.045 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Functioning (PF) | 34.585 Scores on a scale | Standard Deviation 12.241 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Component Score (MCS) | 53.120 Scores on a scale | Standard Deviation 13.91 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Health (MH) | 50.812 Scores on a scale | Standard Deviation 13.626 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Emotional Problems (RE) | 49.770 Scores on a scale | Standard Deviation 12.984 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | General Health (GH) | 39.632 Scores on a scale | Standard Deviation 11.72 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Social Functioning (SF) | 44.123 Scores on a scale | Standard Deviation 14.361 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Component Score (PCS) | 40.716 Scores on a scale | Standard Deviation 10.711 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Functioning (PF) | 35.487 Scores on a scale | Standard Deviation 12.782 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Physical Health (RP) | 42.276 Scores on a scale | Standard Deviation 11.577 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Bodily Pain (BP) | 56.041 Scores on a scale | Standard Deviation 10.951 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | General Health (GH) | 40.245 Scores on a scale | Standard Deviation 11.852 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Vitality (VT) | 47.036 Scores on a scale | Standard Deviation 9.797 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Social Functioning (SF) | 46.980 Scores on a scale | Standard Deviation 13.756 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Emotional Problems (RE) | 49.770 Scores on a scale | Standard Deviation 12.142 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Health (MH) | 49.471 Scores on a scale | Standard Deviation 12.581 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Component Score (MCS) | 51.990 Scores on a scale | Standard Deviation 12.726 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Social Functioning (SF) | 48.019 Scores on a scale | Standard Deviation 15.181 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Vitality (VT) | 47.631 Scores on a scale | Standard Deviation 10.705 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | General Health (GH) | 38.293 Scores on a scale | Standard Deviation 11.171 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Emotional Problems (RE) | 49.030 Scores on a scale | Standard Deviation 12.348 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Component Score (PCS) | 37.890 Scores on a scale | Standard Deviation 12.785 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Bodily Pain (BP) | 51.674 Scores on a scale | Standard Deviation 12.214 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Role Limitation Due to Physical Health (RP) | 41.576 Scores on a scale | Standard Deviation 12.841 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Physical Functioning (PF) | 33.883 Scores on a scale | Standard Deviation 12.836 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Component Score (MCS) | 53.389 Scores on a scale | Standard Deviation 15.119 |
| >18 Months to ≤24 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, >12 Months to ≤18 Months, and >18 Months to ≤24 Months | Mental Health (MH) | 50.276 Scores on a scale | Standard Deviation 13.084 |
Primary
HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months
SF-36 Scores- baseline thru 12 months, where data was available. Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The Data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Baseline to 12 months
Population: Participants with baseline and participating during the period from baseline to ≤18 months data for HRQoL
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Functioning (PF) | 34.197 Scores on a scale | Standard Deviation 11.375 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Physical Health (RP) | 40.492 Scores on a scale | Standard Deviation 12.31 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Bodily Pain (BP) | 47.525 Scores on a scale | Standard Deviation 12.023 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | General Health (GH) | 38.684 Scores on a scale | Standard Deviation 10.164 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Vitality (VT) | 45.714 Scores on a scale | Standard Deviation 11.843 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Social Functioning (SF) | 45.825 Scores on a scale | Standard Deviation 14.089 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Emotional Problems (RE) | 49.014 Scores on a scale | Standard Deviation 11.497 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Health (MH) | 48.390 Scores on a scale | Standard Deviation 11.74 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Component Score (PCS) | 36.803 Scores on a scale | Standard Deviation 11.105 |
| Baseline | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Component Score (MCS) | 51.885 Scores on a scale | Standard Deviation 12.215 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Bodily Pain (BP) | 50.726 Scores on a scale | Standard Deviation 10.942 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Component Score (PCS) | 37.655 Scores on a scale | Standard Deviation 10.609 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | General Health (GH) | 39.718 Scores on a scale | Standard Deviation 9.697 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Vitality (VT) | 46.245 Scores on a scale | Standard Deviation 10.807 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Social Functioning (SF) | 47.218 Scores on a scale | Standard Deviation 11.665 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Emotional Problems (RE) | 48.187 Scores on a scale | Standard Deviation 11.158 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Component Score (MCS) | 52.575 Scores on a scale | Standard Deviation 10.846 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Health (MH) | 50.187 Scores on a scale | Standard Deviation 9.347 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Functioning (PF) | 34.958 Scores on a scale | Standard Deviation 11.048 |
| Baseline to ≤6 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Physical Health (RP) | 39.033 Scores on a scale | Standard Deviation 11.686 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Health (MH) | 49.229 Scores on a scale | Standard Deviation 12.562 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Emotional Problems (RE) | 48.022 Scores on a scale | Standard Deviation 13.331 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Component Score (MCS) | 51.843 Scores on a scale | Standard Deviation 13.323 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Functioning (PF) | 33.301 Scores on a scale | Standard Deviation 11.764 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | General Health (GH) | 39.475 Scores on a scale | Standard Deviation 11.435 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Social Functioning (SF) | 44.781 Scores on a scale | Standard Deviation 14.11 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Component Score (PCS) | 36.171 Scores on a scale | Standard Deviation 10.848 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Physical Health (RP) | 37.887 Scores on a scale | Standard Deviation 12.964 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Vitality (VT) | 45.249 Scores on a scale | Standard Deviation 11.002 |
| >6 Months to ≤12 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Bodily Pain (BP) | 48.990 Scores on a scale | Standard Deviation 13.177 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Vitality (VT) | 45.648 Scores on a scale | Standard Deviation 10.901 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Health (MH) | 48.569 Scores on a scale | Standard Deviation 11.902 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Social Functioning (SF) | 45.013 Scores on a scale | Standard Deviation 14.127 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Mental Component Score (MCS) | 50.814 Scores on a scale | Standard Deviation 12.729 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Emotional Problems (RE) | 47.360 Scores on a scale | Standard Deviation 11.93 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Role Limitation Due to Physical Health (RP) | 40.336 Scores on a scale | Standard Deviation 12.324 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Bodily Pain (BP) | 50.537 Scores on a scale | Standard Deviation 11.789 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | General Health (GH) | 39.586 Scores on a scale | Standard Deviation 10.848 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Functioning (PF) | 33.839 Scores on a scale | Standard Deviation 12.546 |
| >12 Months to ≤18 Months | HRQoL for PF, RP, BP, GH, VT, SF, RE, MH, PCS, and MCS Scores: Baseline, Baseline to ≤6 Months, >6 Months to ≤12 Months, and >12 Months to ≤18 Months | Physical Component Score (PCS) | 38.060 Scores on a scale | Standard Deviation 11.45 |
Primary
HRQoL 'General Health (GH)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'General Health (GH)' From Baseline to ≤6 Months | 37.365 Scores on a scale | Standard Deviation 10.038 |
| Baseline to ≤6 Months | HRQoL 'General Health (GH)' From Baseline to ≤6 Months | 38.737 Scores on a scale | Standard Deviation 10.49 |
Primary
HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months
SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The MCS is a summary scale of the dimensions vitality, social functioning, role emotional, and mental health Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months | 50.464 Scores on a scale | Standard Deviation 11.713 |
| Baseline to ≤6 Months | HRQoL 'Mental Component Score (MCS)' From Baseline to ≤6 Months | 52.378 Scores on a scale | Standard Deviation 10.639 |
p-value: 0.046Paired t-test
Primary
HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months | 47.457 Scores on a scale | Standard Deviation 10.711 |
| Baseline to ≤6 Months | HRQoL 'Mental Health (MH)' From Baseline to ≤6 Months | 50.007 Scores on a scale | Standard Deviation 9.48 |
p-value: 0.006Paired t-test
Primary
HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months
SF-36 scores for baseline (screening) versus the period from baseline to ≤6 Months. The PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months | 34.453 Scores on a scale | Standard Deviation 10.957 |
| Baseline to ≤6 Months | HRQoL 'Physical Component Score (PCS)' From Baseline to ≤6 Months | 35.826 Scores on a scale | Standard Deviation 10.881 |
p-value: 0.044Paired t-test
Primary
HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months | 31.958 Scores on a scale | Standard Deviation 11.291 |
| Baseline to ≤6 Months | HRQoL 'Physical Functioning (PF)' From Baseline to ≤6 Months | 33.129 Scores on a scale | Standard Deviation 11.527 |
Primary
HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months | 48.361 Scores on a scale | Standard Deviation 10.972 |
| Baseline to ≤6 Months | HRQoL 'Role Limitation Due to Emotional Problems (RE)' From Baseline to ≤6 Months | 47.921 Scores on a scale | Standard Deviation 10.855 |
Primary
HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months | 37.631 Scores on a scale | Standard Deviation 11.819 |
| Baseline to ≤6 Months | HRQoL 'Role Limitation Due to Physical Health (RP)' From Baseline to ≤6 Months | 38.139 Scores on a scale | Standard Deviation 11.338 |
Primary
HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months | 42.340 Scores on a scale | Standard Deviation 14.06 |
| Baseline to ≤6 Months | HRQoL 'Social Functioning (SF)' From Baseline to ≤6 Months | 45.581 Scores on a scale | Standard Deviation 12.78 |
p-value: 0.005Paired t-test
Primary
HRQoL 'Vitality (VT)' From Baseline to ≤6 Months
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Quality Metric Incorporated; 2000.
Time frame: Screening to ≤ 6 Months
Population: Participants with baseline and participating during the period from baseline to ≤6 months data for HRQoL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | HRQoL 'Vitality (VT)' From Baseline to ≤6 Months | 42.578 Scores on a scale | Standard Deviation 11.164 |
| Baseline to ≤6 Months | HRQoL 'Vitality (VT)' From Baseline to ≤6 Months | 45.081 Scores on a scale | Standard Deviation 10.916 |
p-value: 0.009Paired t-test
Secondary
ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening
All IgG and IgM titers at screening were ≤ 4. A 2-dilution step increase was defined as follows: • The titer at each 6-month visit must be ≥ 4 when the screening titer = 0 • Each 6-month visit titer / screening titer should be ≥ 4. 6 month window periods are: baseline to ≤6 months, \>6 months to ≤12 months, \>12 months to ≤18 months, and \>18 months to ≤24 months
Time frame: Baseline to 24 Months
Population: Subjects who participated in the blood draws with data available during each window period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgG | 2 Participants |
| Baseline | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgM | 2 Participants |
| Baseline to ≤6 Months | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgM | 1 Participants |
| Baseline to ≤6 Months | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgG | 0 Participants |
| >6 Months to ≤12 Months | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgG | 0 Participants |
| >6 Months to ≤12 Months | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgM | 1 Participants |
| >12 Months to ≤18 Months | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgG | 0 Participants |
| >12 Months to ≤18 Months | ARALAST Antibody Titers: Participants With at Least 2-Dilution Step Increases From Screening | IgM | 0 Participants |
Secondary
Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits'
Number of participants with indicated number of ER visits (0, 1, 2, 3, ≥4 ER visits per participant) during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: Baseline to 24 Months
Population: Participants with data available during each window period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 3 ER visits | 1 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 1 ER visits | 16 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | ≥4 ER visits | 0 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 2 ER visits | 5 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 0 ER visits | 84 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 2 ER visits | 2 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 3 ER visits | 0 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | ≥4 ER visits | 0 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 1 ER visits | 14 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 0 ER visits | 49 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 2 ER visits | 1 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 0 ER visits | 41 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 1 ER visits | 5 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 3 ER visits | 0 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | ≥4 ER visits | 0 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 3 ER visits | 0 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 1 ER visits | 2 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 0 ER visits | 19 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | 2 ER visits | 0 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Emergency Room (ER) Visits' | ≥4 ER visits | 0 Participants |
Secondary
Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations'
Number of participants with indicated number of hospitalizations during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: Baseline to 24 Months
Population: Participants with data available during each window period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 3 Hospitalizations | 1 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 1 Hospitalizations | 17 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | ≥4 Hospitalizations | 0 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 2 Hospitalizations | 2 Participants |
| Baseline | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 0 Hospitalizations | 86 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 2 Hospitalizations | 1 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 3 Hospitalizations | 0 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | ≥4 Hospitalizations | 0 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 1 Hospitalizations | 6 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 0 Hospitalizations | 58 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 2 Hospitalizations | 1 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 0 Hospitalizations | 45 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 1 Hospitalizations | 1 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 3 Hospitalizations | 0 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | ≥4 Hospitalizations | 0 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 3 Hospitalizations | 0 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 1 Hospitalizations | 1 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 0 Hospitalizations | 20 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | 2 Hospitalizations | 0 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Frequency of Hospitalizations' | ≥4 Hospitalizations | 0 Participants |
Secondary
Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital'
Mean LOS during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: Baseline to 24 months
Population: Participants with data available during each window period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital' | 0.8585 Days | Standard Deviation 2.29467 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital' | 0.6462 Days | Standard Deviation 2.68346 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital' | 0.25532 Days | Standard Deviation 1.374742 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Mean Length of Stay (LOS) in Hospital' | 1.1905 Days | Standard Deviation 5.45545 |
Secondary
Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits'
Mean number of ER visits one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: One year prior to baseline to 24 months post-baseline
Population: Participants with data available during each window period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | 0.85 ER visits per time period | Standard Deviation 1.492 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | 0.274 ER visits per time period | Standard Deviation 0.594 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | 0.28 ER visits per time period | Standard Deviation 0.516 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | 0.15 ER visits per time period | Standard Deviation 0.416 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Mean Number of Emergency Room (ER) Visits' | 0.10 ER visits per time period | Standard Deviation 0.301 |
Secondary
Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses'
Number of antibiotic courses (i.e. number of antibiotic prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: One year prior to baseline to 24 months post-baseline
Population: Participants with data available during each window period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | All antibiotic courses (oral and I.V.) | 2.3095 Antibiotic courses | Standard Deviation 2.84384 |
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | I.V. antibiotic courses | 0.4603 Antibiotic courses | Standard Deviation 1.08555 |
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | Oral antibiotic courses | 1.8571 Antibiotic courses | Standard Deviation 2.39571 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | Oral antibiotic courses | 0.8679 Antibiotic courses | Standard Deviation 1.08738 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | All antibiotic courses (oral and I.V.) | 0.9906 Antibiotic courses | Standard Deviation 1.27612 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | I.V. antibiotic courses | 0.1038 Antibiotic courses | Standard Deviation 0.3633 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | Oral antibiotic courses | 0.8154 Antibiotic courses | Standard Deviation 0.96651 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | All antibiotic courses (oral and I.V.) | 0.9231 Antibiotic courses | Standard Deviation 1.07975 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | I.V. antibiotic courses | 0.1077 Antibiotic courses | Standard Deviation 0.35895 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | All antibiotic courses (oral and I.V.) | 0.9787 Antibiotic courses | Standard Deviation 1.40634 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | I.V. antibiotic courses | 0.0851 Antibiotic courses | Standard Deviation 0.28206 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | Oral antibiotic courses | 0.8936 Antibiotic courses | Standard Deviation 1.25515 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | Oral antibiotic courses | 0.6667 Antibiotic courses | Standard Deviation 1.19722 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | All antibiotic courses (oral and I.V.) | 0.7143 Antibiotic courses | Standard Deviation 1.18924 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Antibiotic Courses' | I.V. antibiotic courses | 0.0476 Antibiotic courses | Standard Deviation 0.21822 |
Secondary
Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses'
Number of participants receiving steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: One year prior to baseline to 24 months post-baseline
Population: Participants with data available during each window period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | 65 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | 30 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | 14 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | 12 Participants |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Receiving Steroid Pulse Courses' | 4 Participants |
Secondary
Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics'
Number of participants taking antibiotics one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: One year prior to baseline to 24 months post-baseline
Population: Participants with data available during each window period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | 90 Participants |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | 58 Participants |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | 37 Participants |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | 25 Participants |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Participants Taking Antibiotics' | 8 Participants |
Secondary
Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses'
Number of steroid pulse courses (i.e. number of steroid prescriptions) one year prior to baseline/screening, and during each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: One year prior to baseline to 24 months post-baseline
Population: Participants with data available during each window period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | All steroid pulse courses (oral and I.V.) | 1.4365 Steroid Pulse Courses | Standard Deviation 2.51554 |
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | I.V. steroid pulse courses | 0.3492 Steroid Pulse Courses | Standard Deviation 0.96596 |
| Baseline | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | Oral steroid pulse courses | 1.0873 Steroid Pulse Courses | Standard Deviation 2.13174 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | Oral steroid pulse courses | 0.3585 Steroid Pulse Courses | Standard Deviation 0.84164 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | All steroid pulse courses (oral and I.V.) | 0.4340 Steroid Pulse Courses | Standard Deviation 0.89463 |
| Baseline to ≤6 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | I.V. steroid pulse courses | 0.0849 Steroid Pulse Courses | Standard Deviation 0.28007 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | Oral steroid pulse courses | 0.3692 Steroid Pulse Courses | Standard Deviation 1.03937 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | All steroid pulse courses (oral and I.V.) | 0.4154 Steroid Pulse Courses | Standard Deviation 1.07372 |
| >6 Months to ≤12 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | I.V. steroid pulse courses | 0.0462 Steroid Pulse Courses | Standard Deviation 0.21145 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | All steroid pulse courses (oral and I.V.) | 0.3404 Steroid Pulse Courses | Standard Deviation 0.66844 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | I.V. steroid pulse courses | 0.0638 Steroid Pulse Courses | Standard Deviation 0.24709 |
| >12 Months to ≤18 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | Oral steroid pulse courses | 0.2766 Steroid Pulse Courses | Standard Deviation 0.53981 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | Oral steroid pulse courses | 0.2381 Steroid Pulse Courses | Standard Deviation 0.70034 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | All steroid pulse courses (oral and I.V.) | 0.2857 Steroid Pulse Courses | Standard Deviation 0.71714 |
| >18 Months to ≤24 Months | Healthcare Resource Utilization (HCRU) 'Number of Steroid Pulse Courses' | I.V. steroid pulse courses | 0.0476 Steroid Pulse Courses | Standard Deviation 0.21822 |
Secondary
Hepatic Chemistry Parameters: Change From Baseline/Screening
Summary of changes in hepatic (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase) parameters from screening/baseline through each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: Baseline to 24 months
Population: Subjects who participated in the blood draws with data available during each window period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline | Hepatic Chemistry Parameters: Change From Baseline/Screening | Alkaline phosphatase | -1.00 U/L |
| Baseline | Hepatic Chemistry Parameters: Change From Baseline/Screening | AST | 1.00 U/L |
| Baseline | Hepatic Chemistry Parameters: Change From Baseline/Screening | ALT | 0.00 U/L |
| Baseline to ≤6 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | Alkaline phosphatase | 1.50 U/L |
| Baseline to ≤6 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | AST | 0.00 U/L |
| Baseline to ≤6 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | ALT | 2.50 U/L |
| >6 Months to ≤12 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | ALT | 2.00 U/L |
| >6 Months to ≤12 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | Alkaline phosphatase | -5.50 U/L |
| >6 Months to ≤12 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | AST | 1.00 U/L |
| >12 Months to ≤18 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | Alkaline phosphatase | 0.00 U/L |
| >12 Months to ≤18 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | AST | 0.00 U/L |
| >12 Months to ≤18 Months | Hepatic Chemistry Parameters: Change From Baseline/Screening | ALT | 2.00 U/L |
Secondary
Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening
Summary of changes in hepatic (total bilirubin) and renal (Blood urea nitrogen (BUN), creatinine) parameters from screening/baseline through each window period (Baseline to ≤6 Months, \>6 Months to ≤12 Months, \>12 Months to ≤18 Months, and \>18 Months to ≤24 Months)
Time frame: Baseline to 24 months
Population: Subjects who participated in the blood draws with data available during each window period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Baseline | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Creatinine | 0.02 mg/dL |
| Baseline | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | BUN | 0.65 mg/dL |
| Baseline | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Total bilirubin | 0.00 mg/dL |
| Baseline to ≤6 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Creatinine | 0.01 mg/dL |
| Baseline to ≤6 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | BUN | -0.15 mg/dL |
| Baseline to ≤6 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Total bilirubin | 0.00 mg/dL |
| >6 Months to ≤12 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Total bilirubin | 0.00 mg/dL |
| >6 Months to ≤12 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Creatinine | 0.04 mg/dL |
| >6 Months to ≤12 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | BUN | 1.50 mg/dL |
| >12 Months to ≤18 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Creatinine | 0.00 mg/dL |
| >12 Months to ≤18 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | BUN | -0.50 mg/dL |
| >12 Months to ≤18 Months | Renal and Hepatic Chemistry Parameters: Change From Baseline/Screening | Total bilirubin | 0.00 mg/dL |