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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00839 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000617846 | |||
| MAY06-8-01 | Other Identifier | Mayo Clinic | |
| MAY06-8-01 | Other Identifier | DCP | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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This randomized phase II trial is studying inositol to see how well it works compared with a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of inositol may prevent lung cancer. It is not yet known whether inositol is more effective than a placebo in preventing lung cancer in smokers with bronchial dysplasia.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of myo-inositol (inositol) 9 grams by mouth twice a day for 6 months versus placebo to revert bronchial dysplasia in current/former smokers with or without curatively treated Stage 0/I non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. To further define the mechanism(s) of action of pharmacological doses of myo-inositol as a lung cancer chemopreventive agent by evaluating changes in: the number of dysplastic lesions, Ki-67, caspase-3, peroxisome proliferator-activated receptor (PPAR) gamma, cyclin D1, cyclin E and vascular endothelial growth factor (VEGF) immunostaining in bronchial biopsies; gene expression analysis of ribonucleic acid (RNA) from bronchial brush cells; and changes in inflammatory biomarkers (C-reactive protein [CRP], monocyte chemotactic protein-1 [MCP-1], myeloid progenitor inhibitory factor-1 [MPIF-1] and L-Selectin) levels in bronchoalveolar lavage (BAL) and plasma before and after treatment.
II. To collect additional safety and adverse event profiles of participants enrolled in both intervention arms. III. To establish a biospecimen repository archive for future correlative studies.
OUTLINE: Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of dysplastic lesions at baseline (1 vs > 1). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
ARM II: Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
Patients undergo white light and autofluorescence bronchoscopy with bronchoalveolar lavage, bronchial brushings, and biopsies as well as optical coherence tomography imaging and blood sample collection at baseline and after completion of study treatment. Samples are analyzed for tissue biomarkers (e.g., PPAR gamma, Ki-67, caspase-3, cyclin D1, cyclin E, and VEGF) by immunohistochemistry (IHC); cytokine levels (e.g., CRP, MCP-1, MPIF-1, and L-selectin) by ELISA; and gene expression profiles of RNA by microarray.
After completion of study treatment, patients are followed within 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (inositol) | Experimental | Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
|
| Arm II (placebo) | Experimental | Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression. | From baseline up to 6 months |
| Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease | From baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment | The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions. | From baseline up to 6 months |
| Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia |
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Inclusion Criteria:
Histologically confirmed bronchial dysplasia in ≥ 1 site AND meets one of the following criteria:
Current or former smoker with ≥ a 30 pack-year smoking history and no history of lung cancer
Stage 0 or I non-small cell lung cancer (NSCLC) curatively treated by surgery (local ablation or resection), adjuvant chemotherapy, or radiotherapy with a ≥ 30 pack-year smoking history
No current evidence of lung cancer by CT scan
ECOG performance status 0-1
Hemoglobin normal
Leukocyte count ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 1.5 times ULN
ALT and AST ≤ 1.5 times ULN
BUN ≤ 1.5 times ULN
Chloride ≤ 1.5 times ULN
Total CO_2 ≤ 1.5 times ULN
Sodium ≤ 1.5 times ULN
Calcium ≤ 1.5 times ULN
Potassium ≤ 1.5 times ULN
Phosphorus ≤ 1.5 times ULN
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30mL/min
Fasting blood glucose normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No cancer within the past 3 years except stage 0 or I NSCLC, nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was treated > 6 months ago
No concurrent uncontrolled illness including, but not limited to, any of the following:
No schizophrenia or bipolar disorder
No diabetes
No requirement for supplemental oxygen (continuous or intermittent)
SaO_2 ≥ 90% on room air
No history of allergic reactions attributed to inositol
No history of allergies to any ingredient in the study agent or placebo
No other concurrent investigational agents
At least 7 days since prior anticoagulant use (e.g., coumadin or heparin)
More than 6 months since prior participation in another chemoprevention clinical trial
No prior pneumonectomy
No prior solid organ transplantation
No concurrent lithium, carbamazepine, or valproate
No concurrent use of other natural health products containing inositol
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| Name | Affiliation | Role |
|---|---|---|
| Paul Limburg | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
363 subjects were excluded from pre-assignment: 342 ineligible via bronchoscopy, 3 participant decision, 13 lab values out of range, 1 screening time line issue and 4 suspicious of cancer.
448 subjects were pre-registered through 3 Cancer Prevention Network (CPN) member organizations from 2008 to 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Myo-inositol) | Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
| FG001 | Arm B (Placebo) | Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Myo-inositol) | Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
| BG001 | Arm B (Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Participant-specific Analysis. | The definitions of responses are: Complete response: regression of all dysplastic lesion (DL) found at baseline to lesions that were no worse than hyperplasia and no new DL that were mild dysplasia or worse; Partial response: regression of some but not all of the DL with no new lesions that are mild dysplasia or worse; Progressive disease: progression of one or more sites by two or more grades or new DL that were mild dysplasia or worse; Stable disease: no complete response, partial response or progression. | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy. | Posted | Number | percentage of participants | From baseline up to 6 months |
|
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Adverse events reported on all participants. The adverse events: cardiac disorders, blood disorders, gastrointestinal disorder and etc. which are simply repeating their organ system names were referred to other, specify category of the adverse events.
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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 | Arm A (Myo-inositol) | Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | CTCAEV3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTCAEV3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul J. Limburg, M.D., M.P.H. | Mayo Clinic Rochester | 507-284-2511 | limburg.paul@mayo.edu |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| inositol |
| Drug |
Given orally |
|
|
| From baseline up to 6 months |
| Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | From baseline up to 6 months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Albuquerque Veterans Administration Medical Center | Albuquerque | New Mexico | 87108-5128 | United States |
| BCCA-Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Lost to Follow-up |
|
Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index, kg/m^2 | Median | Full Range | kg/m^2 |
|
| Smoking Status | Number | participants |
|
| Prior NSAID (nonsteroidal anti-inflammatory drugs) Use | Number | participants |
|
| Alcohol Intake | Number | participants |
|
| Dysplastic Lesions Identified | Number | participants |
|
| Mucosal Biopsies Obtained | Median | Full Range | biopsies |
|
| Most Advanced Histology | Number | participants |
|
Patients receive oral inositol once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
| OG001 | Arm B (Placebo) | Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. |
|
|
| Primary | Percentage of Participants With Response Determined by Change in the Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples on Lesion-specific Analysis. | The definitions of responses are: Complete response: the regression of a dysplastic lesion (DL) of any grade to one classified as being hyperplastic/normal; Progressive disease: appearance of lesions that were classified as mild dysplasia or worse; Stable disease: lesions that are not classified as complete response or progressive disease | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy. | Posted | Number | percentage of participants | From baseline up to 6 months |
|
|
|
|
| Secondary | Percent Change in the Number of Bronchial Dysplastic Lesions Before and After Treatment | The change in the number of bronchial dysplastic lesions is defined as disappearance or appearance of lesions. | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied. | Posted | Mean | Standard Deviation | percentage change in number of lesions | From baseline up to 6 months |
|
|
|
| Secondary | Mean Percent Change in Ki-67 Expression Level in the Bronchial Biopsies With Dysplasia | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with lesions biopsied. | Posted | Mean | Standard Deviation | percentage of Ki67 expression level | From baseline up to 6 months |
|
|
|
| Secondary | Change in Gene Expression Profiles of RNA in Bronchial Brush Cell Samples as Assessed by Microarray | Data were not collected due to a study team decision not to analyze this endpoint. | Posted | From baseline up to 6 months |
|
|
| Secondary | Change in Inflammatory Biomarkers Levels (CC-16) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
|
|
|
|
| Secondary | Change in Inflammatory Biomarkers Levels (IL-6) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | pg/mL | From baseline up to 6 months |
|
|
|
|
| Secondary | Change in Inflammatory Biomarkers Levels (CCL-2) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | pg/mL | From baseline up to 6 months |
|
|
|
|
| Secondary | Change in Inflammatory Biomarkers Levels (MPO) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
|
|
|
|
| Secondary | Change in Inflammatory Biomarkers Levels (CC18) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
|
|
|
|
| Secondary | Change in Inflammatory Biomarkers Levels (SFTPD) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (Total Glutathione) in Bronchoalveolar Lavage Samples as Assessed by Enzyme-linked Immunoassay (ELISA) | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with bronchoalveolar lavage samples available | Posted | Median | Inter-Quartile Range | umol/L | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (CC-16) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (CRP) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (IL-6) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | pg/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (CCL-2) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | pg/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (MPO) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (Nitrotyrosine) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | mmol/L | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (CC18) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
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| Secondary | Change in Inflammatory Biomarkers Levels (SFTPD) in Plasma Samples as Assessed by ELISA | The biomarkers that were examined were: 1) pro-inflammatory proteins: C-reactive protein (CRP, R&D Systems), interleukin-6 (IL-6, R&D Systems), and CCL-2 (R&D Systems); 2) oxidant/antioxidants: myeloperoxidase (MPO, R&D Systems), nitrotyrosine (Hycult Biotech) and glutathione (Millipore-Calbiochem); and 3) pneumoproteins: Clara cell protein-16 (CC-16, Biovendor), surfactant protein-D (SFTPD, R&D Systems) and CC18 (R&D Systems). | The analysis population included the participants who received study intervention and completed both the pre- and post-intervention bronchoscopy with plasma samples available | Posted | Median | Inter-Quartile Range | ng/mL | From baseline up to 6 months |
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| 1 |
| 44 |
| 36 |
| 44 |
| EG001 | Arm B (Placebo) | Patients receive oral placebo once daily for 2 weeks and then twice daily for up to 6 months in the absence of unacceptable toxicity. | 0 | 41 | 32 | 41 |
| Palpitations | Cardiac disorders | CTCAEV3.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAEV3.0 | Systematic Assessment |
|
| Middle ear inflammation | Ear and labyrinth disorders | CTCAEV3.0 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAEV3.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAEV3.0 | Systematic Assessment |
|
| Cataract | Eye disorders | CTCAEV3.0 | Systematic Assessment |
|
| Vitreous hemorrhage | Eye disorders | CTCAEV3.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Chest pain | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Chills | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| General symptom | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Localized edema | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Pain | General disorders | CTCAEV3.0 | Systematic Assessment |
|
| Hepatobiliary disease | Hepatobiliary disorders | CTCAEV3.0 | Systematic Assessment |
|
| Bladder infection | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Peripheral nerve infection | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAEV3.0 | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAEV3.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | CTCAEV3.0 | Systematic Assessment |
|
| Laboratory test abnormal | Investigations | CTCAEV3.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAEV3.0 | Systematic Assessment |
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| Weight gain | Investigations | CTCAEV3.0 | Systematic Assessment |
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| Weight loss | Investigations | CTCAEV3.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAEV3.0 | Systematic Assessment |
|
| Blood glucose increased | Metabolism and nutrition disorders | CTCAEV3.0 | Systematic Assessment |
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| Blood uric acid increased | Metabolism and nutrition disorders | CTCAEV3.0 | Systematic Assessment |
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| Serum sodium decreased | Metabolism and nutrition disorders | CTCAEV3.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Joint disorder | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Joint range of motion decreased cervical spine | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAEV3.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAEV3.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAEV3.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAEV3.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | CTCAEV3.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAEV3.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAEV3.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAEV3.0 | Systematic Assessment |
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| Hemoglobin urine positive | Renal and urinary disorders | CTCAEV3.0 | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAEV3.0 | Systematic Assessment |
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| Urogenital disorder | Renal and urinary disorders | CTCAEV3.0 | Systematic Assessment |
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| Penile pain | Reproductive system and breast disorders | CTCAEV3.0 | Systematic Assessment |
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| Prostatic pain | Reproductive system and breast disorders | CTCAEV3.0 | Systematic Assessment |
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| Reproductive tract disorder | Reproductive system and breast disorders | CTCAEV3.0 | Systematic Assessment |
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| Testicular pain | Reproductive system and breast disorders | CTCAEV3.0 | Systematic Assessment |
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| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
|
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Rash desquamating | Skin and subcutaneous tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Sweating | Skin and subcutaneous tissue disorders | CTCAEV3.0 | Systematic Assessment |
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| Hematoma | Vascular disorders | CTCAEV3.0 | Systematic Assessment |
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| Hemorrhage | Vascular disorders | CTCAEV3.0 | Systematic Assessment |
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| Hot flashes | Vascular disorders | CTCAEV3.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAEV3.0 | Systematic Assessment |
|
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Progressive disease |
|