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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004126-16 |
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This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8mg/kg iv every 4 weeks for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs. | Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score (DAS28) | DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanta-Hämeen Keskussairaala ; Reumatologia | Hämeenlinna | 13530 | Finland | |||
| Kiljavan Lääketutkimus Oy |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab | Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all participants who entered the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab | Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs. | Analysis population included all participants who entered the study. | Posted | Number | percentage of participants | Baseline up to Week 24 |
|
Up to 24 weeks
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tocilizumab | Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erysipelas | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
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| Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6) | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response | ACR20, ACR50, and ACR70 response: greater than or equal to (>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do). | Weeks 4, 8, 12, 16, 20, and 24 |
| C-Reactive Protein (CRP) Level | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Erythrocyte Sedimentation Rate (ESR) | The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour. | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
| Percentage of Participants Who Discontinued the Study | Up to Week 24 |
| Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal | Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum. | Up to Week 24 |
| Percentage of Participants With Lipid Level Elevations | Low density lipoprotein (LDL) level was categorized as 'Optimal (less than [<] 100 milligram per deciliter [mg/dL])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as 'Acceptable (40-59 mg/dL)', 'High (>=60 mg/dL)'. Total cholesterol (TC) level was categorized as 'Desirable (<200 mg/dL)', 'Borderline High (200-239 mg/dL)', 'High (>=240 mg/dL)'. | Week 24 |
| Neutrophil Count | Baseline, Weeks 4, 8, and 12 |
| Hyvinkää |
| 05800 |
| Finland |
| Kanta-Hämeen keskussairaala; Riihimäen aluesairaala Reumapoliklinikka | Riihimäki | 11101 | Finland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Disease Activity Score (DAS28) | DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6) | DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*GH of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission. | Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response | ACR20, ACR50, and ACR70 response: greater than or equal to (>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do). | Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category. | Posted | Number | percentage of participants | Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | C-Reactive Protein (CRP) Level | Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | milligram per liter (mg/L) | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Erythrocyte Sedimentation Rate (ESR) | The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour. | Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | millimeter per hour (mm/h) | Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Discontinued the Study | Analysis population included all participants who entered the study. | Posted | Number | percentage of participants | Up to Week 24 |
|
|
|
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal | Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum. | Analysis population included all participants who entered the study. | Posted | Number | percentage of participants | Up to Week 24 |
|
|
|
| Secondary | Percentage of Participants With Lipid Level Elevations | Low density lipoprotein (LDL) level was categorized as 'Optimal (less than [<] 100 milligram per deciliter [mg/dL])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as 'Acceptable (40-59 mg/dL)', 'High (>=60 mg/dL)'. Total cholesterol (TC) level was categorized as 'Desirable (<200 mg/dL)', 'Borderline High (200-239 mg/dL)', 'High (>=240 mg/dL)'. | Analysis population included all participants who entered the study. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Secondary | Neutrophil Count | Analysis population included all participants who entered the study. 'n'=number of participants evaluable for specified category. | Posted | Mean | Standard Deviation | E^9 per liter | Baseline, Weeks 4, 8, and 12 |
|
|
|
| 1 |
| 14 |
| 13 |
| 14 |
| Arrhythmia | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Oral infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Lipids increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| DAS28 ESR: Week 12 (n=12) |
|
| DAS28 ESR: Week 16 (n=13) |
|
| DAS28 ESR: Week 20 (n=13) |
|
| DAS28 ESR: Week 24 (n=13) |
|
| DAS28 CRP: Baseline (n=14) |
|
| DAS28 CRP: Week 4 (n=14) |
|
| DAS28 CRP: Week 8 (n=13) |
|
| DAS28 CRP: Week 12 (n=12) |
|
| DAS28 CRP: Week 16 (n=13) |
|
| DAS28 CRP: Week 20 (n=13) |
|
| DAS28 CRP: Week 24 (n=13) |
|
| Title | Measurements |
|---|---|
|
| DAS28 ESR: Week 16 (n=13) |
|
| DAS28 ESR: Week 20 (n=13) |
|
| DAS28 ESR: Week 24 (n=13) |
|
| DAS28 CRP: Week 4 (n=14) |
|
| DAS28 CRP: Week 8 (n=13) |
|
| DAS28 CRP: Week 12 (n=12) |
|
| DAS28 CRP: Week 16 (n=13) |
|
| DAS28 CRP: Week 20 (n=13) |
|
| DAS28 CRP: Week 24 (n=13) |
|
| Title | Measurements |
|---|---|
|
| ACR20: Week 16 (n=13) |
|
| ACR20: Week 20 (n=13) |
|
| ACR20: Week 24 (n=13) |
|
| ACR50: Week 4 (n=14) |
|
| ACR50: Week 8 (n=13) |
|
| ACR50: Week 12 (n=13) |
|
| ACR50: Week 16 (n=13) |
|
| ACR50: Week 20 (n=13) |
|
| ACR50: Week 24 (n=13) |
|
| ACR70: Week 4 (n=14) |
|
| ACR70: Week 8 (n=13) |
|
| ACR70: Week 12 (n=13) |
|
| ACR70: Week 16 (n=13) |
|
| ACR70: Week 20 (n=13) |
|
| ACR70: Week 24 (n=13) |
|
|
| Week 12 (n=12) |
|
| Week 16 (n=13) |
|
| Week 20 (n=13) |
|
| Week 24 (n=13) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=12) |
|
| Week 16 (n=13) |
|
| Week 20 (n=13) |
|
| Week 24 (n=13) |
|
| Title | Measurements |
|---|---|
|
| LDL: High |
|
| LDL: Very high |
|
| HDL: Acceptable |
|
| HDL: High |
|
| TC: Desirable |
|
| TC: Borderline High |
|
| TC: High |
|
|
| Week 12 (n=11) |
|