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| Name | Class |
|---|---|
| Abbott Japan Co.,Ltd | INDUSTRY |
| Eisai Co., Ltd. | INDUSTRY |
Not provided
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The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in Japanese subjects with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab 40 mg every other week (eow) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | 40 mg eow, sc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
A subject who experienced any of the following during prior study:
A subject who has been prescribed excluded medications during prior study.
History of following during prior study:
A subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period
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| Name | Affiliation | Role |
|---|---|---|
| Shigeki Hashimoto, Ph.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Metropolis | Japan | ||||
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Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab 40 mg Eow | Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab 40 mg Eow | Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) | Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Number | participants | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
Onset after first injection of study drug through 70 days after last injection for subjects who discontinued and through Week 216 for those who remained on study
Not provided
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 | Adalimumab 40 mg Eow | Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
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 |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
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| Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). |
| Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). |
| Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). |
| Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Presence of Morning Stiffness | The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Presence of Rheumatoid Factor (RF) | The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
| Aichi |
| Prefecture |
| Japan |
| Chiba | Prefecture | Japan |
| Ehime | Prefecture | Japan |
| Fukui | Prefecture | Japan |
| Fukuoka | Prefecture | Japan |
| Gunma | Prefecture | Japan |
| Hokkaido | Prefecture | Japan |
| Hyōgo | Prefecture | Japan |
| Ibaraki | Prefecture | Japan |
| Ishikawa | Prefecture | Japan |
| Kagoshima | Prefecture | Japan |
| Kanagawa | Prefecture | Japan |
| Kyoto | Prefecture | Japan |
| Miyagi | Prefecture | Japan |
| Nagano | Prefecture | Japan |
| Nagasaki | Prefecture | Japan |
| Niigata | Prefecture | Japan |
| Okayama | Prefecture | Japan |
| Osaka | Prefecture | Japan |
| Saitama | Prefecture | Japan |
| Shizuoka | Prefecture | Japan |
| Tochigi | Prefecture | Japan |
| Tokushima | Prefecture | Japan |
| Toyama | Prefecture | Japan |
| Withdrawal by Subject |
|
| Administrative reason |
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Adalimumab 40 mg Eow | Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan |
|
|
| Secondary | Mean Change From Baseline in Tender Joint Count (TJC, Max=68), a Component of the American College of Rheumatology (ACR) by Visit | Mean change from Baseline in TJC (max=68) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | TJC | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Mean Change From Baseline in Swollen Joint Count (SJC, Max=66), a Component of the American College of Rheumatology (ACR) by Visit | Mean change from Baseline in SJC (max=66) at each visit, a component of ACR. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing)] of the M02-575 study; for the M02-575 rescue arm, the baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | SJC | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Mean Change From Baseline in Physician Global Assessment of Disease Activity (PGA), a Component of the ACR Criteria by Visit | Change from Baseline in PGA (a visual analog scale from 0-100 mm, with 0 being the absence of disease activity and 100 mm being very strong disease activity, a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | mm on a scale | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). |
|
|
|
| Secondary | Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Change from Baseline in Subject's Global Assessment of Disease Activity (a visual analog scale from 0-100 mm (0 being absence of disease activity and 100 being very strong disease activity), a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | mm on unit scale | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). |
|
|
|
| Secondary | Mean Change From Baseline in Subject's Assessment of Pain Using a Visual Analog Scale, a Component of the ACR Criteria by Visit | Change from Baseline in subject's assessment of pain (a visual analog scale from 0-100 mm [0 being no pain and 100 being unbearable pain], a component of the ACR criteria by visit). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 (before dosing) of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 (before dosing) of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | mm on unit scale | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value). |
|
|
|
| Secondary | Mean Change From Baseline in the Disability Index of the Health Assessment Questionaire (DI-HAQ, a Component of the American College of Rheumatology (ACR) Criteria by Visit | Mean change from Baseline in DI-HAQ overall score (includes 20 questions assessing physical function in 8 domains - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities). Each question is on a scale of 0-3 mm to measure the ability to perform certain activities (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do so), a component of the ACR criteria by visit. DI-HAQ is derived based on the mean of individual responses not the total of individual questions | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | mm on a scale | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Mean Change From Baseline in C-reactive Protein (CRP), a Component of the American College of Rheumatology (ACR) Criteria by Visit | Mean change from Baseline in CRP (mg/dL), a component of the ACR criteria by visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | mg/dL | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Presence of Morning Stiffness | The number of subjects with morning stiffness at each visit. For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Number | participants | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Mean Change From Baseline in the Duration (Minutes) of Morning Stiffness by Visit | Mean change (minutes) from Baseline in morning stiffness (duration). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | minutes | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Presence of Rheumatoid Factor (RF) | The number of subjects who were positive for rheumatoid factor (RF) at each visit. RF considered negative if <=20 IU/mL and positive if >20 IU/mL. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Number | participants | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| Secondary | Mean Change From Baseline in Rheumatoid Factor (IU/ML) by Visit | Mean change from Baseline in RF (IU/mL). For M02-575 completers, the Baseline for all efficacy analyses was defined as the Week 0 [before dosing] of the M02-575 study; for the M02-575 rescue arm, the Baseline was defined as the Week 0 [before dosing] of the M03-651 study. | Full Analysis Set - all subjects who received at least one treatment with the study drug were included in the maximum population for analysis. In this study, the safety set was defined to be identical to the full analysis set. Analysis was based on observed data. | Posted | Mean | Standard Deviation | IU/mL | Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) |
|
|
|
| 111 |
| 309 |
| 285 |
| 309 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Atlantoaxial instability | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Atypical mycobacterial infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Blood Beta-D-Glucan increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchiectasis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebral hemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cervical cord compression | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cervical myelopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Chest x-ray abnormal | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Computerised tomogram abnormal | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cryptogenic organizing pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Decreased activity | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dermoid cyst of ovary | Congenital, familial and genetic disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Entertis infectious | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Femur fracture | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Foot deformity | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hand deformity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Herpes ophthalmic | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Joint destruction | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Medical device complication | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Middle lobe syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteoarthritis | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteonecrosis | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Parovarian cyst | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyothorax | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Scapula fracture | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Secondary amyloidosis | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Splenic haemorrhage | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Splenic infarction | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Staphylococcal bacteremia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
|
| Vasodilatation | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Antinuclear antibody positive | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| DNA antibody positive | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| TJC Week 8 (n=304) |
|
| TJC Week 12 (n=298) |
|
| TJC Week 16 (n=287) |
|
| TJC Week 20 (n=271) |
|
| TJC Week 24 (n=261) |
|
| TJC Week 36 (n=245) |
|
| TJC Week 48(n=232) |
|
| TJC Week 60 (n=209) |
|
| TJC Week 72 (n=162) |
|
| TJC Week 84 (n=125) |
|
| TJC Week 96 (n=102) |
|
| TJC Week 108 (n=95) |
|
| TJC Week 120 (n=91) |
|
| TJC Week 132 (n=90) |
|
| TJC Week 144 (n=87) |
|
| TJC Week 156(n=82) |
|
| TJC Week 168 (n=78) |
|
| TJC Week 180 (n=59) |
|
| TJC Week 192 (n=33) |
|
| TJC Week 204 (n=9) |
|
| TJC Week 216 (n=1) |
|
| TJC Final Value (n=309) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=304) |
|
| Week 12 (n=298) |
|
| Week 16 (n=287) |
|
| Week 20 (n=271) |
|
| Week 24 (n=261) |
|
| Week 36 (n=245) |
|
| Week 48 (n=232) |
|
| Week 60 (n=209) |
|
| Week 72 (n=162) |
|
| Week 84 (n=125) |
|
| Week 96 (n=102) |
|
| Week 108 (n=95) |
|
| Week 120 (n=91) |
|
| Week 132 (n=90) |
|
| Week 144 (n=87) |
|
| Week 156 (n=82) |
|
| Week 168 (n=72) |
|
| Week 180 (n=59) |
|
| Week 192 (n=33) |
|
| Week 204 (n=9) |
|
| Week 216 (n=1) |
|
| Final Value (n=309) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=304) |
|
| Week 12 (n=298) |
|
| Week 16 (n=286) |
|
| Week 20 (n=271) |
|
| Week 24 (n=261) |
|
| Week 36 (n=245) |
|
| Week 48 (n=232) |
|
| Week 60 (n=209) |
|
| Week 72 (n=162) |
|
| Week 84 (n=125) |
|
| Week 96 (n=102) |
|
| Week 108 (n=94) |
|
| Week 120 (n=91) |
|
| Week 132 (n=90) |
|
| Week 144 (n=87) |
|
| Week 156 (n=82) |
|
| Week 168 (n=78) |
|
| Week 180 (n=59) |
|
| Week 192 (n=33) |
|
| Week 204 (n=9) |
|
| Week 216 (n=1) |
|
| Final Value (n=309) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=304) |
|
| Week 12 (n=298) |
|
| Week 16 (n=287) |
|
| Week 20 (n=271) |
|
| Week 24 (n=261) |
|
| Week 36 (n=244) |
|
| Week 48 (n=231) |
|
| Week 60 (n=209) |
|
| Week 72 (n=162) |
|
| Week 84 (n=125) |
|
| Week 96 (n=102) |
|
| Week 108 (n=95) |
|
| Week 120 (n=90) |
|
| Week 132 (n=90) |
|
| Week 144 (n=87) |
|
| Week 156 (n=82) |
|
| Week 168 (n=78) |
|
| Week 180 (n=59) |
|
| Week 192 (n=33) |
|
| Week 204 (n=8) |
|
| Week 216 (n=1) |
|
| Final Value (n=309) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=304) |
|
| Week 12 (n=298) |
|
| Week 16 (n=287) |
|
| Week 20 (n=271) |
|
| Week 24 (n=261) |
|
| Week 36 (n=244) |
|
| Week 48 (n=231) |
|
| Week 60 (n=209) |
|
| Week 72 (n=162) |
|
| Week 84 (n=125) |
|
| Week 96 (n=102) |
|
| Week 108 (n=95) |
|
| Week 120 (n=90) |
|
| Week 132 (n=90) |
|
| Week 144 (n=87) |
|
| Week 156 (n=82) |
|
| Week 168 (n=78) |
|
| Week 180 (n=59) |
|
| Week 192 (n=33) |
|
| Week 204 (n=9) |
|
| Week 216 (n=1) |
|
| Final Value (n=309) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=304) |
|
| Week 12 (n=298) |
|
| Week 16 (n=287) |
|
| Week 20 (n=271) |
|
| Week 24 (n=261) |
|
| Week 36 (n=244) |
|
| Week 48 (n=231) |
|
| Week 60 (n=209) |
|
| Week 72 (n=162) |
|
| Week 84 (n=125) |
|
| Week 96 (n=102) |
|
| Week 108 (n=95) |
|
| Week 120 (n=90) |
|
| Week 132 (n=90) |
|
| Week 144 (n=87) |
|
| Week 156 (n=82) |
|
| Week 168 (n=78) |
|
| Week 180 (n=59) |
|
| Week 192 (n=33) |
|
| Week 204 (n=9) |
|
| Week 216 (n=1) |
|
| Final Visit (n=309) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=303) |
|
| Week 12 (n=298) |
|
| Week 16 (n=287) |
|
| Week 20 (n=271) |
|
| Week 24 (n=261) |
|
| Week 36 (n=245) |
|
| Week 48 (n=231) |
|
| Week 60 (n=209) |
|
| Week 72 (n=162) |
|
| Week 84 (n=125) |
|
| Week 96 (n=102) |
|
| Week 108 (n=95) |
|
| Week 120 (n=91) |
|
| Week 132 (n=90) |
|
| Week 144 (n=87) |
|
| Week 156 (n=82) |
|
| Week 168 (n=78) |
|
| Week 180 (n=58) |
|
| Week 192 (n=33) |
|
| Week 204 (n=9) |
|
| Week 216 (n=1) |
|
| Final Value (n=309) |
|
| Title | Measurements |
|---|
|
| Week 12 |
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 36 |
|
| Week 48 |
|
| Week 60 |
|
| Week 72 |
|
| Week 84 |
|
| Week 96 |
|
| Week 108 |
|
| Week 120 |
|
| Week 132 |
|
| Week 144 |
|
| Week 156 |
|
| Week 168 |
|
| Week 180 |
|
| Week 192 |
|
| Week 204 |
|
| Week 216 |
|
| Final Value |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=168) |
|
| Week 12 (n=167) |
|
| Week 16 (n=154) |
|
| Week 20 (n=148) |
|
| Week 24 (n=138) |
|
| Week 36 (n=106) |
|
| Week 48 (n=93) |
|
| Week 60 (n=91) |
|
| Week 72 (n=68) |
|
| Week 84 (n=47) |
|
| Week 96 (n=39) |
|
| Week 108 (n=29) |
|
| Week 120 (n=29) |
|
| Week 132 (n=29) |
|
| Week 144 (n=32) |
|
| Week 156 (n=20) |
|
| Week 168 (n=19) |
|
| Week 180 (n=16) |
|
| Week 192 (n=11) |
|
| Week 204 (n=1) |
|
| Final Value (n=238) |
|
| Title | Measurements |
|---|
|
| Week 96 |
|
| Week 120 |
|
| Week 144 |
|
| Week 168 |
|
| Week 192 |
|
| Week 216 |
|
| Final Value |
|
| Title | Measurements |
|---|---|
|
| Week 72 (n=185) |
|
| Week 96 (n=112) |
|
| Week 120 (n=93) |
|
| Week 144 (n=88) |
|
| Week 168 (n=80) |
|
| Week 192 (n=41) |
|
| Week 216 (n=4) |
|
| Fina Value (n=308) |
|