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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00896 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2006-4937 | |||
| UCI03-1-01 | |||
| CDR0000540141 | |||
| UCI 06-06 | Other Identifier | Chao Family Comprehensive Cancer Center | |
| UCI03-1-01 | Other Identifier | DCP | |
| N01CN35160 | U.S. NIH Grant/Contract | View source |
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The use of lovastatin may slow disease progression in patients at high risk of melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or placebo works in treating patients at high risk of melanoma.
PRIMARY OBJECTIVES:
I. To evaluate the primary endpoint of the trial, by analysis of histopathologic regression of atypical nevi in response to a 6-month trial of oral (PO) lovastatin vs. placebo in subjects with atypical nevi.
SECONDARY OBJECTIVES:
I. To evaluate clinical regression of atypical nevi in the lovastatin vs. placebo group.
II. To evaluate the secondary endpoint of changes in nevi numbers on subjects' backs in the lovastatin vs. placebo groups.
III. To evaluate a number of molecular biomarkers as secondary endpoints in the lovastatin vs. placebo groups.
IV. To evaluate the correlation of serum markers known to be affected by lovastatin with the endpoints chosen above.
V. To evaluate the safety and tolerability of the dosing regimen, and the dose escalation.
OUTLINE: Patients are randomized into 1 of 2 treatment arms per group.
ARM I: Patients (with two matched nevi OR one large nevi) receive lovastatin PO once daily (QD) for up to 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients (with two matched nevi OR one large nevi) receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two matched nevi group - Lovastatin | Experimental | Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. |
|
| Two Matched Nevi Group - Placebo | Placebo Comparator | Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity |
|
| One large nevi group - Lovastatin | Experimental | Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity |
|
| One Large Nevi Group - Placebo | Placebo Comparator | Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lovastatin | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation | The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers. | From baseline up to 24 weeks |
| Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation | The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers. | From baseline up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations | From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin. |
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Inclusion Criteria:
Presence of at least 2 clinically atypical nevi on the body that are reasonably matched in regards to level of clinical atypia, or one atypical mole and another atypical mole >= 8 mm in diameter (for this pair the two moles do not have to be closely matched and only one of them must be >= 8 mm in diameter)
A history of melanoma is not required for study entry
Patients with completely resected stage I or II who have not received adjuvant therapy in the past 3 months
Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better (Karnofsky > 70%)
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 100,000/uL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X within normal limits
Creatinine within normal institutional limits
Ability to understand and the willingness to sign the written informed consent
Subjects willing and able to participate for the full duration of the study
For women of child-bearing potential (women are considered not of childbearing potential if they are at least 2 years post-menopausal and/or surgically sterile), she:
Men partnered with a female of child-bearing age must agree to use adequate contraception while on the study (i.e. abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom)
Exclusion Criteria:
Subjects with untreated melanoma of any stage or locally advanced (>= 4 mm in Breslow's thickness) or metastatic (stage III or IV) melanoma; subjects with melanoma may be considered for trial after complete resection of Stage I or II melanoma and those who have declined or are ineligible to go on any available adjuvant clinical trials known to the investigators or the subjects are eligible
Subjects who are on adjuvant therapy or experimental therapy for melanoma currently or within the last 3 months prior to enrollment into this study
Subjects currently or within the last three months before enrollment on lipid lowering agents of any type
History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin
Clinically significant unrelated systemic illness
Subjects with any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize his/her participation in and compliance with the study
Subjects may not be receiving any other investigational agents
Pregnant or breast feeding females, or females of child bearing age not using a reliable method of contraception (use of lovastatin is contraindicated in pregnancy)
Subjects who have been diagnosed with malignancies other than cutaneous melanoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma within 5 years of study entry, unless they:
Chronic use of: itraconazole; ketoconazole; erythromycin; clarithromycin; telithromycin; human immunodeficiency virus (HIV) protease inhibitors; nefazodone; cyclosporine; gemfibrozil and other fibrates; danazol; amiodarone (amiodarone hydrochloride); verapamil; coumarin anticoagulants; niacin (nicotinic acid) (>= 1 g/day); or large quantities of grapefruit juice (> l quart daily)
Subjects with a history of coronary artery disease or stroke
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Linden | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Medical Center At Irvine-Orange Campus | Orange | California | 92868 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Two Matched Nevi Group - Lovastatin | Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| FG001 | Two Matched Nevi Group - Placebo | Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| FG002 | One Large Nevi Group - Lovastatin | Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| FG003 | One Large Nevi Group - Placebo | Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Two Matched Nevi Group-Lovastatin | Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| BG001 | Two Matched Nevi Group-Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 1's Evaluation | The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers. | Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers. | Posted | Mean | Standard Deviation | score | From baseline up to 24 weeks |
|
The onset date of adverse event is between the randomization date and the date of off-study.
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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 | Two Matched Nevi Group-Lovastatin | Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ELEVATED CPK | Investigations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 3 NEW MOLES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth G. Linden | University of California, Irvine | 714-456-3719 | kglinden@uci.edu |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| placebo | Other | Given PO |
|
|
| biopsy | Procedure | Correlative studies |
|
|
| laboratory biomarker analysis | Procedure | Correlative studies |
|
| From baseline up to 24 weeks |
| Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Assessed by photos of subjects' back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation | HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation | (e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation | (n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation | VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation | RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation | p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation | Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation | HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation | (e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation | (n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation | VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation | RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation | p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation | Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | From baseline up to 24 weeks |
| Change in Cholesterol (mg/dL) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in LDL (mg/dL) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in HDL (mg/dL) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in Triglycerides (mg/dL) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in SGOT/AST (U/L) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in SGOT/ALT (U/L) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in CPK (U/L) From Baseline After Treatment | Baseline up to 24 weeks |
| Change in C-reactive Protein (mg/dL) From Baseline After Treatment | Baseline up to 24 weeks |
| At Least 1 Study-related Adverse Event Reported During the Study | All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. | Baseline up to 26 weeks |
| H. Lee Moffitt Cancer Center and Research Institute |
| Tampa |
| Florida |
| 33612 |
| United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| BG002 | One Large Nevi Group-Lovastatin | Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| BG003 | One Large Nevi Group-Placebo | Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. lovastatin: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
| OG001 | Two Matched Nevi Group - Placebo | Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies |
|
|
| Secondary | Clinical Regression of Atypical Moles - Average of Three Reviewers' Evaluations | From close-up photos of target atypical nevi, lesions will be graded clinically. After unblinding of pre- or post-treatment status for photos, the grading score was as follows: 1= Post-treatment (Post-TX) photo shows a complete resolution of atypia relative to pre-treatment (Pre-TX) photo, 2 = Post-TX photo shows a strong lessening of atypia relative to Pre-TX photo, 3 = Post-TX photo shows a mild lessening of atypia relative to Pre-TX photo, 4 = Post-TX and Pre-TX photos show same degree of atypia, 5 = Pre-TX photo shows a mild lessening of atypia relative to Post-TX photo, 6 = Pre-TX photo shows a strong lessening of atypia relative to Post-TX photo, 7 = Pre-TX photo shows a complete resolution of atypia relative to Post-TX photo. The Wilcoxon rank sum test will be applied to compare the scores for patients treated with placebo vs. those treated with lovastatin. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | Standard Deviation | score | From baseline up to 24 weeks |
|
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|
|
| Secondary | Total Nevus Number on Patient's Back - Combined Three Reviewers' Evaluations | Assessed by photos of subjects' back pre and post treatment. These photos will be used to count, by blinded evaluators, the number of nevi on the back pre and post therapy. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Number | pairs of photos | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - HIF1alpha: Pathologist 3's Evaluation | HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 3's Evaluation | (e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Primary | Histopathologic Regression of Target Atypical Nevi With Treatment - Pathologist 2's Evaluation | The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. For each patient, the change from baseline in the level of atypia was calculated. Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers. | Only the Two Matched Nevi Group - Lovastatin and Two Matched Nevi Group - Placebo data were used and analyzed for the primary outcome. One-Large Nevi Group - Lovastatin and One-Large Nevi Group - Placebo sample data were not used or analyzed due to insufficient numbers. | Posted | Mean | Standard Deviation | score | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 3's Evaluation | (n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - VEGF: Pathologist 3's Evaluation | VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - RelA: Pathologist 3's Evaluation | RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 3's Evaluation | p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - Ki-67: Pathologist 3's Evaluation | Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - HIF1alpha: Pathologist 4's Evaluation | HIF1alpha expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - (e)-Cadherin: Pathologist 4's Evaluation | (e)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - (n)-Cadherin: Pathologist 4's Evaluation | (n)-cadherin expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - VEGF: Pathologist 4's Evaluation | VEGF expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - RelA: Pathologist 4's Evaluation | RelA expression was assessed via cytoplasmic staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - p21 (WAF1/CIP1): Pathologist 4's Evaluation | p21 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Serum and Molecular Biomarkers - Ki-67: Pathologist 4's Evaluation | Ki-67 expression was assessed via nuclear staining, and the change in the percentage of positive stained cells from baseline to 24 weeks is calculated. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | percentage of cells that are positive | From baseline up to 24 weeks |
|
|
|
| Secondary | Change in Cholesterol (mg/dL) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in LDL (mg/dL) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in HDL (mg/dL) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in Triglycerides (mg/dL) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in SGOT/AST (U/L) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | U/L | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in SGOT/ALT (U/L) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | U/L | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in CPK (U/L) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | U/L | Baseline up to 24 weeks |
|
|
|
| Secondary | Change in C-reactive Protein (mg/dL) From Baseline After Treatment | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. The total number of participants who have complete data are analyzed in this outcome measure. | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline up to 24 weeks |
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| Secondary | At Least 1 Study-related Adverse Event Reported During the Study | All participants will be evaluable for toxicity from the time of their informed consent. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. | One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the "Lovastatin" arm while One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the "Placebo" arm. | Posted | Number | participants | Baseline up to 26 weeks |
|
|
|
| 1 |
| 34 |
| 27 |
| 34 |
| EG001 | Two Matched Nevi Group-Placebo | Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity. placebo: Given PO biopsy: Correlative studies laboratory biomarker analysis: Correlative studies | 2 | 32 | 25 | 32 |
| EG002 | One Large Nevi Group-Lovastatin | Patients who have one large nevi received lovastatin PO QD for up to 6 months | 0 | 7 | 4 | 7 |
| EG003 | One Large Nevi Group-Placebo | Patients who have one large nevi receive placebo PO QD for up to 6 months | 1 | 7 | 5 | 7 |
| HYPERBILIRUBINEMIA | Investigations | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Non-systematic Assessment |
|
| ROTATOR CUFF SURGERY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ACID REFLUX | Gastrointestinal disorders | Non-systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| ALT SGPT | Investigations | Non-systematic Assessment |
|
| ARMS TINGLING AT NIGHT | Nervous system disorders | Non-systematic Assessment |
|
| AST SGOT | Investigations | Non-systematic Assessment |
|
| ATYPICAL MOLE BIOPSY | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| BIOPSY SITE INFECTION | Infections and infestations | Non-systematic Assessment |
|
| BLADDER INFECTION | Renal and urinary disorders | Non-systematic Assessment |
|
| BLOATING | Gastrointestinal disorders | Non-systematic Assessment |
|
| BREAST TENDERNESS | Reproductive system and breast disorders | Non-systematic Assessment |
|
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| COLD | General disorders | Non-systematic Assessment |
|
| COLD SORE OUTBREAK | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| COLD SYMPTOMS | General disorders | Non-systematic Assessment |
|
| COLD-FEVER | General disorders | Non-systematic Assessment |
|
| COLPOSCOPY-STOMACH DISCOMFORT | Gastrointestinal disorders | Non-systematic Assessment |
|
| COMMON COLD | Infections and infestations | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
|
| CONSTIPATION( INTERMITTANT) | Gastrointestinal disorders | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| CPK | Investigations | Non-systematic Assessment |
|
| CRAMPS | Gastrointestinal disorders | Non-systematic Assessment |
|
| DECREASED LIBIDO | Psychiatric disorders | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| DIZZINESS | Nervous system disorders | Non-systematic Assessment |
|
| DIZZINESS - INTERMITTENT - 2-3 TIMES A WEEK | Nervous system disorders | Non-systematic Assessment |
|
| DRY FINGER TIPS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| ELEVATED BILIRUBIN LEVEL | Investigations | Non-systematic Assessment |
|
| ELEVATED CPK | Investigations | Non-systematic Assessment |
|
| ELEVATED CREATINE KINASE | Investigations | Non-systematic Assessment |
|
| ELEVATED LDH | Investigations | Non-systematic Assessment |
|
| ELEVATED TOTAL CK | Investigations | Non-systematic Assessment |
|
| ELEVATED TRIGLYCERIDES | Investigations | Non-systematic Assessment |
|
| EXTRA URINE | Renal and urinary disorders | Non-systematic Assessment |
|
| FACELIFT | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| FATIGUE | General disorders | Non-systematic Assessment |
|
| FEVER | General disorders | Non-systematic Assessment |
|
| FEVER SORE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| FIBROIDS | Reproductive system and breast disorders | Non-systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
|
| FLU | General disorders | Non-systematic Assessment |
|
| FLU-FEVER | General disorders | Non-systematic Assessment |
|
| GAS | Gastrointestinal disorders | Non-systematic Assessment |
|
| HEADACHE | Nervous system disorders | Non-systematic Assessment |
|
| HEARTBURN | Gastrointestinal disorders | Non-systematic Assessment |
|
| HIGH BLOOD PRESSURE | Cardiac disorders | Non-systematic Assessment |
|
| HIGH CHOLESTEROL LEVEL | Investigations | Non-systematic Assessment |
|
| HIVES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| INDIGESTION | Gastrointestinal disorders | Non-systematic Assessment |
|
| INFLUENZA | General disorders | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
|
| INTERMITTENT INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
|
| INTERMITTENT NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| ITCHY AT BIOPSY SITE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| ITCHY HAND | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| JOINT PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| JOINT/BONE PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| KIDNEY INFECTION | Infections and infestations | Non-systematic Assessment |
|
| LARYNGITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| LEFT HIP PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| LEFT HIP SENSITIVITY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| LIGHTHEADEDNESS | Nervous system disorders | Non-systematic Assessment |
|
| LOOSE STOOLS | Gastrointestinal disorders | Non-systematic Assessment |
|
| LOWER BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MENSTRUAL CRAMPS | Reproductive system and breast disorders | Non-systematic Assessment |
|
| MIGRAINE | Nervous system disorders | Non-systematic Assessment |
|
| MOLE CHANGE, FATTER AND LIGHTER | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| MOLE ON NECK CHANGE IN APPEARANCE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| MOLE REMOVAL | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| MOLES (2) BIOPSIED | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| MOTION SICKNESS | Gastrointestinal disorders | Non-systematic Assessment |
|
| MOUTH ULCERS | Gastrointestinal disorders | Non-systematic Assessment |
|
| MUSCLE ACHE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MUSCLE CRAMPS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MUSCLE CRAMPS/PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MUSCLE PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MUSCLE PAIN - NECK, BACK, SHOULDER | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MUSCLE PAIN AND ACHES; | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| MUSCLE TWITCHES IN THE UPPER LEFT ARM | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| NECK PAIN-ARTHRITIC | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| NEW FOOT PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| NUMBNESS AND SHOOTING PAIN IN LOWER BACK AND LEGS | Nervous system disorders | Non-systematic Assessment |
|
| NUMBNESS AND TINGLING IN THE RIGHT ARM | Nervous system disorders | Non-systematic Assessment |
|
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PAIN IN BREASTS | Reproductive system and breast disorders | Non-systematic Assessment |
|
| PAIN LOWER BACK | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PAIN-SHOULDER MUSCLE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PERIPHERAL NERVOUS SYSTEM ( PARESTHESIA) TINGLING SKIN- LEFT SIDE FACE. | Nervous system disorders | Non-systematic Assessment |
|
| PHARYNIGITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PNS LEFT HAND PARESTHESIA | Nervous system disorders | Non-systematic Assessment |
|
| PULLED BACK - LUMBAR SPINE INJURY | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| PULLED TENDON | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| RIB PAIN - INTERMITTENT | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| RIGHT HIP PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| RIGHT KNEE PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| RIGHT LEG WEAKNESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| ROOT CANAL | Gastrointestinal disorders | Non-systematic Assessment |
|
| SCALY MOLE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SEBORRHEIC KERATOSIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SHINGLES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| SINUS INFECTION | Infections and infestations | Non-systematic Assessment |
|
| SINUSITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| SKIN CHANGES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SKIN RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SKIN REACTION TO BANDAID ADHESIVE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SKIN TAG CHANGE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SLIGHTLY ATYPICAL LENTIGO | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SOFT STOOLS | Gastrointestinal disorders | Non-systematic Assessment |
|
| SORE BACK | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SORE CALF MUSCLES | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| SORE THROAT | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| SPRAINED FINGER-PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| STOMACH ACHE | Gastrointestinal disorders | Non-systematic Assessment |
|
| STOMACH DISCOMFORT | Gastrointestinal disorders | Non-systematic Assessment |
|
| STOMACH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
|
| STOMACH UPSET | Gastrointestinal disorders | Non-systematic Assessment |
|
| STOMACH UPSET/GASTROENTERITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| STREP THROAT | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| SUNBURN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SWOLLEN ANKLE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| TEETH SENSITIVITY | Gastrointestinal disorders | Non-systematic Assessment |
|
| THYROID CANCER | Endocrine disorders | Non-systematic Assessment |
|
| TINGLING IN R PALM | Nervous system disorders | Non-systematic Assessment |
|
| TINGLING IN R THUMB & R INDEX | Nervous system disorders | Non-systematic Assessment |
|
| TINGLING IN THE FEET | Nervous system disorders | Non-systematic Assessment |
|
| TIRED | General disorders | Non-systematic Assessment |
|
| TOOTH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
|
| UNKNOWN CHANGE IN THE CERVICAL LYMPH NODE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| UNKNOWN PERIPHERAL NERVOUS SYSTEM | Nervous system disorders | Non-systematic Assessment |
|
| UPPER RESPIRATORY INFECTION | Infections and infestations | Non-systematic Assessment |
|
| URI | Infections and infestations | Non-systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
|
| VISUAL DISTURBANCES | Eye disorders | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
|
| WISDOM TEETH EXTRACTION - TOOTH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
|
| YEAST INFECTION | Infections and infestations | Non-systematic Assessment |
|
Not provided
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| More nevi after the treatment |
|