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To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.
This was a Phase 3, multicenter, open-label, Early Access Study with an induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 in subjects with moderately to severely active Crohn's Disease (CD) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. Failure of prior therapy was determined by the Investigator. Subjects were to have an 8-week wash-out period prior to Baseline from the last dose of infliximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open Label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | 160 mg loading dose, 80 mg at week 2, 40 mg every other week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Extent of Exposure - Duration in Days | Extent of exposure for all adalimumab treated subjects | Up to 24 weeks |
| Total Number of Injections of Adalimumab | Extent of exposure for all adalimumab treated subjects | Up to 24 weeks |
| Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections. | Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study). | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline). | Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit. | Week 12, Week 24, and Last Assessment Value (last nonmissing value) |
| Overall Health Care Resource Utilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jimmy Baloukas | Abbott | Study Director |
| Remo Panaccione, MD, FRCPC | Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Medical Information - Abbott | Abbott Park | Illinois | 60064 | United States |
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| Label | URL |
|---|---|
| For more information, see attached website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 40 mg Adalimumab Every Other Week | Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 40 mg Adalimumab Every Other Week | Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Extent of Exposure - Duration in Days | Extent of exposure for all adalimumab treated subjects | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | days | Up to 24 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 40 mg Adalimumab Every Other Week | Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MeDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
Subjects who failed prior infliximab therapy were eligible to enter study after minimum 8 week wash-out since last dose. Includes subjects who previously used infliximab & never responded or responded & developed intolerance/lost efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Specialist | Abbott Laboratories | Phone: (800) 633-9110 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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From the "Overall Health Care Resource Utilization Questionnaire": Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization. |
| Up to 24 weeks |
| Employment Status: Number of Subjects Employed | Summary of employment status of those employed. | Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
| 50% Improvement in Draining Fistula Count and Fistula Healing | Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent. | Week 12, Week 24, Last Assessment Value (last nonmissing value) |
| Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment | Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity). Minimal clinically important difference = 7 points. Measure is Mean percent change. | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
| Hematology - Change From Baseline to Final Visit | Changes from the Group mean at baseline are compared to the final visit Group mean value | Up to 24 weeks |
| Clinical Chemistry - Change From Baseline to Final Visit | Changes from the Group mean at Baseline are compared to the final visit Group mean value | Up to 24 weeks |
| Urinalysis - Change From Baseline to Final Visit | Changes from the Group mean at baseline are compared to the final visit Group mean value | Up to 24 weeks |
| Work Productivity and Activity Impairment - Change From Baseline in Absenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%. | Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value) |
| Work Productivity and Activity Impairment - Change From Baseline in Presenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%. | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
| Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%. | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
| Other reason not specified |
|
| Adverse Event + Hospitalization |
|
| Adverse Event + Withdrew Consent |
|
| Adverse Event + No Response |
|
| Adverse Event + Worsening of CD |
|
| Adverse Event + No Therapeutic Benefit |
|
| Adverse Event + Lost Response |
|
| Adverse Event + Withdrawn from Study |
|
| Withdrew Consent + Lack of Efficacy |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | Participants |
|
| Alcohol | Number | participants |
|
| C-Reactive protein mg/dL | Number | participants |
|
| Nicotine | Number | participants |
|
| Number Subjects With Draining Cutaneous Fistulas at Screening | Number | participants |
|
| Number Subjects with Perianal Fistulas at Screening | Number | Participants |
|
| Number of Subjects with Abdominal Fistulas at Screening | Number | Participants |
|
| Summary of Locations of Crohn's Disease at Screening (All Treated Subjects) | Crohn's Disease may be at multiple locations | Number | participants |
|
| Weight in kilograms | Number | Participants |
|
| Duration of Crohn's Disease at Screening in Years | Mean | Standard Deviation | years |
|
| Participants |
|
|
| Post-Hoc | Harvey-Bradshaw Index (HBI) Mean Change From Baseline | HBI score (range 0-30) sum subtotal of 5 parameters of subject's CD activity: a)Well being 0=very well-4=terrible b) Abdominal pain 0=none- 3=severe c) Number liquid stools per day d) Abdominal mass 0=none-3=tender e) Complications: 1 point each. Decrease indicates improvement. Absolute decrease of 3 units on scale is clinically important. | Intent to Treat - subjects who received at least one dose of study drug. | Posted | Mean | 95% Confidence Interval | Units on scale | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| Secondary | Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline). | Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit. | Posted | Mean | Standard Deviation | number of fistulas | Week 12, Week 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| Primary | Total Number of Injections of Adalimumab | Extent of exposure for all adalimumab treated subjects | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | injections | Up to 24 weeks |
|
|
|
| Primary | Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections. | Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study). | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | Percentage of injections | Up to 24 weeks |
|
|
|
| Post-Hoc | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline | Quality of life questionnaire for patients with IBD consisting of 4 domains: systemic, social, emotional, and bowel. This is a 10-item questionnaire, and all items are reported with a 7-point scale (ranging from 1 = poor HRQOL, to 7 = optimum HRQOL). Total SIBDQ score ranges from 10 (quality of life has been negatively affected tremendously by IBD) to 70 (quality of life is barely impacted by IBD). A change greater than 9 points was the minimal clinically important difference (MCID). | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| Secondary | Overall Health Care Resource Utilization | From the "Overall Health Care Resource Utilization Questionnaire": Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization. | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | number of visits | Up to 24 weeks |
|
|
|
| Secondary | Employment Status: Number of Subjects Employed | Summary of employment status of those employed. | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Number | participants | Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| Secondary | 50% Improvement in Draining Fistula Count and Fistula Healing | Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent. | Intent To Treat | Posted | Number | participants | Week 12, Week 24, Last Assessment Value (last nonmissing value) |
|
|
|
| Secondary | Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment | Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity). Minimal clinically important difference = 7 points. Measure is Mean percent change. | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | Units on scale | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| Secondary | Hematology - Change From Baseline to Final Visit | Changes from the Group mean at baseline are compared to the final visit Group mean value | Posted | Mean | Standard Deviation | number | Up to 24 weeks |
|
|
|
| Secondary | Clinical Chemistry - Change From Baseline to Final Visit | Changes from the Group mean at Baseline are compared to the final visit Group mean value | Posted | Mean | Standard Deviation | number | Up to 24 weeks |
|
|
|
| Secondary | Urinalysis - Change From Baseline to Final Visit | Changes from the Group mean at baseline are compared to the final visit Group mean value | Posted | Mean | Standard Deviation | number | Up to 24 weeks |
|
|
|
| Secondary | Work Productivity and Activity Impairment - Change From Baseline in Absenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%. | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value) |
|
|
|
| Secondary | Work Productivity and Activity Impairment - Change From Baseline in Presenteeism | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%. | In addition to the ITT population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | Units on scale | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| Secondary | Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment | The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%. | In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set. | Posted | Mean | Standard Deviation | Units on scale | Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) |
|
|
|
| 44 |
| 133 |
| heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| atroventricular block complete | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Crohn's Disease | Gastrointestinal disorders | , MedDRA 10.1 | Systematic Assessment |
|
| GI haemorrhage | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| GI motility disorder | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| ileal perforation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| internal hernia | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| small intestinal obstruction | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| subileus | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| death | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| inflammation | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| abdominal abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| appendicitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| perianal abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| pneumonia legionella | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| rectal abscess | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| anastomotic complication | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| anatomotic leak | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| haemoglobin decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| fistula | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| nephrolithiasis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| renal colic | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| pulmonary emolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Crohn's Disease | Gastrointestinal disorders | Systematic Assessment |
|
Responsibility of preparation and maintenance of the single database, first publication, and, presentation of Study shall reside with Abbott. No independent manuscript may be submitted for publication until first manuscript has been accepted for publication or twelve (12) months after completion of the Study at all sites, which ever occurs first.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Last Assessment Value |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Last Assessment Value |
|
|
| Number of days of hospitalizations |
|
| Title | Measurements |
|---|---|
|
| Week 12 |
|
| Week 24 |
|
| Last Assessment Value |
|
| Title | Measurements |
|---|---|
|
| Week 12 Fistula Healing |
|
| Week 24 Fistula Healing |
|
| Last Assessment Value Fistula Healing |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Last Assessment Value |
|
|
| Platelet Count (x10^9/L) |
|
| White blood cell count (x10^9/L) |
|
| Neutrophils (x10^9/L) |
|
| Lymphocytes (x10^9/L) |
|
| Monocytes (x10^9/L) |
|
| Eosinophils (x10^9/L) |
|
| Basophils (x10^9/L) |
|
|
| Total Bilirubin (mcmol/L) |
|
| Creatinine (mcmol/L) |
|
| BUN (mmol/L) |
|
| Uric acid (mcmol/L) |
|
| Inorganic phosphate |
|
| Calcium (mmol/L) |
|
| Sodium (mmol/L) |
|
| Potassium (mmol/L) |
|
| Albumin (G/L) |
|
| Total protein (G/L) |
|
| Cholesterol (mmol/L) |
|
| Triglycerides (mmol/L) |
|
| C-reactive protein (mg/L) |
|
| Glucose - fasting (mmol/L) |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Last Assessment Value |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Last Assessment Value |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Last Assessment Value |
|