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The purpose of this study was to evaluate the impact of the co-morbidities profile on treatment response to biological therapy in inflammatory bowel disease (IBD) participants.
This was a retrospective, non-interventional, observational study that included participants diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013. The study looked at the impact of the co-morbidities on the treatment response in IBD participants.
The study enrolled 310 patients included both UC and CD patients.
This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Crohn's Disease | Participants with Crohn's disease who received biological treatment between June 2011 and June 2013. |
| |
| Cohort 2: Ulcerative Colitis | Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy | Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease. | Up to 10 weeks after start of treatment with biologics |
| Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease. | Up to 6 months after start of treatment with biologics |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy | Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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Ulcerative colitis (UC) and Crohn's disease (CD) participants who started treatment with biologics between June 2011 and June 2013 will participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santiago de Compostela | A Coruna | Spain | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32337054 | Derived | Marin-Jimenez I, Bastida G, Fores A, Garcia-Planella E, Arguelles-Arias F, Sarasa P, Tagarro I, Fernandez-Nistal A, Montoto C, Aguas M, Santos-Fernandez J, Bosca-Watts MM, Ferreiro R, Merino O, Aldeguer X, Cortes X, Sicilia B, Mesonero F, Barreiro-de Acosta M. Impact of comorbidities on anti-TNFalpha response and relapse in patients with inflammatory bowel disease: the VERNE study. BMJ Open Gastroenterol. 2020 Mar 26;7(1):e000351. doi: 10.1136/bmjgast-2019-000351. eCollection 2020. |
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Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants with a diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013, participated in the study. Total 357 participants were registered, out of which only 310 participants were analyzed.
Participants took part in the study at the 25 investigative sites in Spain from 26 October 2016 to 04 April 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Crohn's Disease | Participants with Crohn's disease who received biological treatment between June 2011 and June 2013. |
| FG001 | Cohort 2: Ulcerative Colitis | Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2017 | Apr 2, 2019 |
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| Up to 10 weeks after start of treatment with biologics |
| Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease. | Up to 6 months after start of treatment with biologics |
| Percentage of IBD Participants With Comorbidities | Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition. | Day 1 |
| Percentage of CD Participants With Comorbidities According to the Level of IBD Severity | Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. | Day 1 |
| Percentage of UC Participants With Comorbidities According to the Level of IBD Severity | Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score is sum of sub scale scores ranging from 0=normal to 9=severe disease. | Day 1 |
| Huesca |
| Aragon |
| Spain |
| Alcázar de San Juan | Ciudad Real | Spain |
| Girona | Gerona | Spain |
| Las Palmas | Gran Canaria | Spain |
| Alcorcón | Madrid | Spain |
| Fuenlabrada | Madrid | Spain |
| Parla | Madrid | Spain |
| Pamplona | Navarre | Spain |
| Vigo | Pontevedra | Spain |
| Gijón | Principality of Asturias | Spain |
| Castellon | Valencia | Spain |
| Sagunto | Valencia | Spain |
| Barakaldo | Vizcaya | Spain |
| Barcelona | Spain |
| Burgos | Spain |
| Ciudad Real | Spain |
| Madrid | Spain |
| Murcia | Spain |
| Santander | Spain |
| Seville | Spain |
| Valencia | Spain |
| Valladolid | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Crohn's Disease | Participants with Crohn's disease who received biological treatment between June 2011 and June 2013. |
| BG001 | Cohort 2: Ulcerative Colitis | Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Working Status | Count of Participants | Participants |
| ||||||||||||||||
| Level of Education | Count of Participants | Participants |
| ||||||||||||||||
| Smoking Habits | Count of Participants | Participants |
| ||||||||||||||||
| Alcohol Abuse | Number analyzed is the number of participants with evaluable data at this baseline measure. | Count of Participants | 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 | Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy | Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. | Posted | Number | 95% Confidence Interval | odds ratio | Up to 10 weeks after start of treatment with biologics |
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| Primary | Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. | Posted | Number | 95% Confidence Interval | odds ratio | Up to 6 months after start of treatment with biologics |
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| Secondary | Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy | Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. | Posted | Number | 95% Confidence Interval | odds ratio | Up to 10 weeks after start of treatment with biologics |
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| Secondary | Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy | Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, logistic regression models were conducted. Loss of response was defined as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. | Posted | Number | 95% Confidence Interval | odds ratio | Up to 6 months after start of treatment with biologics |
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| Secondary | Percentage of IBD Participants With Comorbidities | Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Number | percentage of participants | Day 1 |
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| Secondary | Percentage of CD Participants With Comorbidities According to the Level of IBD Severity | Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Number | percentage of participants | Day 1 |
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| Secondary | Percentage of UC Participants With Comorbidities According to the Level of IBD Severity | Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score is sum of sub scale scores ranging from 0=normal to 9=severe disease. | Analyzed participants included all participants who didn't had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point. | Posted | Number | percentage of participants | Day 1 |
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Time since participants started biological treatment until study visit (Day 1)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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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 | Cohort 1: Crohn's Disease | Participants with Crohn's disease who received biological treatment between June 2011 and June 2013. | 0 | 194 | 0 | 194 | 0 | 194 |
| EG001 | Cohort 2: Ulcerative Colitis | Participants with ulcerative colitis who received biological treatment between June 2011 and June 2013. | 0 | 116 | 1 | 116 | 0 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 13, 2016 | Jul 9, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| Female |
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| Not Available |
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| Latin |
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| Gipsy |
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| Arab |
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| Not Available |
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| Self Employed |
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| Retired |
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| Housework |
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| Unemployed |
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| Student |
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| Permanently Unable to Work |
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| Temporarily Unable to Work |
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| Other |
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| Not Available |
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| Primary Education |
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| University Education |
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| Uneducated |
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| Not Available |
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| Ex-smoker |
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| Smoker |
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| Not Available |
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| No |
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| Not Available |
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| Title | Measurements |
|---|---|
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| Other |
| Chronic Obstructive Pulmonary Disease | Regression, Logistic | 0.006 | Other |
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| Units | Counts |
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