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Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00118365
Collaborator
(none)
375
Enrollment
1
Location
2
Arms
121
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

PRIMARY OBJECTIVES:

  1. Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.

  2. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients.

  3. Compare the rate of side effects in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).

Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral double placebo once daily.

Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.

In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

Study Design

Study Type:
Interventional
Actual Enrollment :
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon
Study Start Date :
Jul 1, 1998
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Arm II (placebo)

Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

Other: placebo
Given orally
Other Names:
  • PLCB

    • Other: laboratory biomarker analysis
    Correlative studies
    Experimental: Arm I (eflornithine and sulindac)

    Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

    Drug: eflornithine
    Given orally
    Other Names:
  • 2-difluoromethylornithine
  • DFMO
  • difluromethylornithine

    • Drug: sulindac
    Given orally
    Other Names:
  • Aflodac
  • Algocetil
  • Clinoril
  • SULIN

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Detection of Any Adenoma at the End of the Study [Up to 36 months]

      Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.

    Secondary Outcome Measures

    1. Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment [Up to 36 months]

      This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.

    2. Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment [Up 36 months]

      The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.

    3. Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment [Up 36 months]

      The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort. In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.

    4. Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment [Up to 36 months]

      PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.

    5. Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment [Up to 36 months]

      Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.

    6. Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment [Up to 36 months]

      Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.

    7. Adverse Events With a Grade of 3 and Above [Up to 36 months]

      Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other. Per protocol, not all grade 3 events are considered as serious events.

    8. Baseline Putrescine by ODC Genotype [Baseline]

      ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    9. Baseline Spermidine by ODC Genotype [Baseline]

      ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    10. Baseline Spermine by ODC Genotype [Baseline]

      ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    11. At the End of the Study - Putrescine Response by ODC Genotype [At the end of the study]

      Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30. ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    12. At the End of the Study - Spermidine Response by ODC Genotype [At the end of the study]

      Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30. ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    13. At the End of the Study - Spermine Response by ODC Genotype [At the end of the study]

      Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30. ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    14. Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group [Up to 36 months]

      ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.

    15. Biomarker in Adenoma: Apoptosis [At the end of the study]

      Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.

    16. Biomarker in Adenoma - Ki-67 [At the end of the study]

      Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates

    17. Biomarker in Adenoma: CEA [At the end of the study]

      carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.

    18. Biomarker in Adenoma: Sialyl-TN (B72.3) [At the end of the study]

      sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.

    19. Biomarker in Adenoma - p53 [At the end of the study]

      Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates. Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene.

    20. Biomarker in Adenoma: Bcl-2 [At the end of the study, up to 3 years]

      bcl-2 is the anti-apoptotic protein BCL2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Criteria:

    • History of >= 1 surgically resected adenomatous polyp of the colon measuring >= 3 mm within the past 5 years

    • Screening colonoscopy performed within the past 6 months

    • All polyps must have been removed during colonoscopy, pathologically examined, and archived

    • No prior surgical resection removing > 40 cm of the colon

    • No personal or family history of familial polyposis or hereditary non-polyposis colon cancer

    • SWOG 0-1

    • Bilirubin =< 2.0 mg/dL

    • AST and ALT =< 2 times normal

    • Creatinine =< 1.5 mg/dL

    • Urine protein =<, urine casts 0-3, urine WBC and RBC count 0-5 cells by urinalysis

    • No history of inflammatory bowel disease

    • No gastric or duodenal ulcers within the past 12 months

    • Gastric or duodenal ulcers that were adequately treated > 24 months ago are allowed

    • No symptomatic gastric or duodenal ulcers

    • Not pregnant or nursing

    • Negative pregnancy test

    • Must have regional geographic stability over the next 36 months

    • Pure tone audiometry evaluation normal

    • Patients with >= 20 dB of uncorrectable hearing loss (for age) of any 2 contiguous frequencies are not allowed

    • No invasive malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, level I (or Breslow < 0.76 mm) cutaneous melanoma, Duke's A colon cancer, stage I cervical cancer, or stage 0 chronic lymphocytic leukemia

    • No severe metabolic disorder

    • No other significant acute or chronic disease that would preclude study participation

    • No history of abnormal wound healing or repair

    • No conditions that would confer risk of abnormal wound healing or repair

    • No history of allergy to NSAIDs or eflornithine

    • No concurrent chemotherapy

    • No concurrent corticosteroids on a regular or predictable intermittent basis

    • No concurrent radiotherapy

    • Concurrent calcium supplements (=< 1,000 mg/day) allowed

    • Concurrent lipid-lowering drugs (i.e., high-dose statins) allowed

    • No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular or predictable intermittent basis

    • Concurrent aspirin for cardiovascular prophylaxis (i.e., 81 mg/day) allowed

    • No concurrent anticoagulants on a regular or predictable intermittent basis

    • No concurrent treatment for gastric or duodenal ulcers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California Medical Center At Irvine-Orange Campus Orange California United States 92868

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Frank Meyskens, University of California Medical Center At Irvine-Orange Campus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00118365
    Other Study ID Numbers:
    • NCI-2009-00880
    • UCI 97-05
    • R01CA088078
    • NCT00005882
    First Posted:
    Jul 11, 2005
    Last Update Posted:
    Jan 22, 2015
    Last Verified:
    Feb 1, 2014
    Additional relevant MeSH terms:
    Precancerous Conditions
    Eflornithine
    Sulindac

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Period Title: Overall Study
    STARTED 191 184
    COMPLETED 132 124
    NOT COMPLETED 59 60

    Baseline Characteristics

    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo) Total
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Total of all reporting groups
    Overall Participants 191 184 375
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    60
    (8.6)
    61
    (8.4)
    60.5
    (8.40)
    Sex: Female, Male (Count of Participants)
    Female
    44
    23%
    46
    25%
    90
    24%
    Male
    147
    77%
    138
    75%
    285
    76%

    Outcome Measures

    1. Primary Outcome
    Title Detection of Any Adenoma at the End of the Study
    Description Detection of any adenoma at the end of the study. This analysis is based on the participants who had the end-of-study colonscopy procedure done.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    This analysis is based on the participants who had the end-of-study colonscopy procedure done.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 138 129
    Yes
    17
    8.9%
    53
    28.8%
    No
    121
    63.4%
    76
    41.3%
    2. Secondary Outcome
    Title Detection of Any Adenoma at the End of the Study Stratified by Baseline Prostaglandin E2 (PGE2) and Treatment
    Description This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    This analysis is based on the participants who had the end-of-study colonscopy procedure done and their baseline PGE2 values are available. The low PGE2 is defined as the values that are below the median PGE2 value in the analysis cohort. The high PGE2 is defined as the values that are above the median PGE2 value in the analysis cohort.
    Arm/Group Title Eflornithine and Sulindac + Low PGE2 at Baseline Eflornithine and Sulindac + High PGE2 at Baseline Placebo + Low PGE2 at Baseline Placebo + High PGE2 at Baseline
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 values is below the median Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 values is above the median Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is below median Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline PGE2 value is above median
    Measure Participants 53 44 42 53
    Yes
    12
    6.3%
    3
    1.6%
    19
    5.1%
    21
    NaN
    No
    41
    21.5%
    41
    22.3%
    23
    6.1%
    32
    NaN
    3. Secondary Outcome
    Title Detection of Any Adenoma at the End of the Study Stratified by Baseline Putrescine and Treatment
    Description The low is defined as the values that are below the median putrescine level in the analysis cohort. The high is defined as the values that are above the median putrescine level in the analysis cohort.
    Time Frame Up 36 months

    Outcome Measure Data

    Analysis Population Description
    In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title Eflornithine and Sulindac + Low Putrescine at Baseline Eflornithine and Sulindac + High Putrescine at Baseline Placebo + Low Putrescine at Baseline Placebo + High Putrescine at Baseline
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies baseline Putrescine values is below the median Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies baseline Putrescine values is above the median Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline Putrescine value is below median Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline Putrescine value is above median
    Measure Participants 70 66 62 67
    Yes
    7
    3.7%
    10
    5.4%
    24
    6.4%
    31
    NaN
    No
    63
    33%
    56
    30.4%
    38
    10.1%
    36
    NaN
    4. Secondary Outcome
    Title Detection of Any Adenoma at the End of the Study Stratified by Baseline Spermidine-to-spermine Ratio and Treatment
    Description The low is defined as the ratios that are below the median spermidine-to-spermine ratio in the analysis cohort. The high is defined as the ratios that are above the median spermidine-to-spermine ratio in the analysis cohort. In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Up 36 months

    Outcome Measure Data

    Analysis Population Description
    In the finalized datasaet, the total number of adnoma detected in the placebo group is 55. The descrepancy in the total number of adnoma detected in placebo group between Outcome Measure 1 and this oucome is due to the revolution of the datatset. The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title Eflornithine and Sulindac + Low Spd:Spm at Baseline Eflornithine and Sulindac + High Spd:Spm at Baseline Placebo + Low Spd:Spm at Baseline Placebo + High Spd:Spm at Baseline
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies baseline spermidine-to-spermine ratio is below the median Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies baseline spermidine-to-spermine ratio is above the median Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline spermidine-to-spermine ratio is below median Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies baseline spermidine-to-spermine ratio is above median
    Measure Participants 64 72 68 61
    Yes
    5
    2.6%
    12
    6.5%
    31
    8.3%
    24
    NaN
    No
    59
    30.9%
    60
    32.6%
    37
    9.9%
    37
    NaN
    5. Secondary Outcome
    Title Detection of Any Adenoma at the End of the Study Stratified by Prostaglandin E2 (PGE2) Response and Treatment
    Description PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title Eflornithine and Sulindac + PGE2 Responders Eflornithine and Sulindac + PGE2 Nonresponders Placebo + PGE2 Responders Placebo + PGE2 Nonresponders
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline
    Measure Participants 11 35 17 32
    Yes
    1
    0.5%
    8
    4.3%
    4
    1.1%
    15
    NaN
    No
    10
    5.2%
    27
    14.7%
    13
    3.5%
    17
    NaN
    6. Secondary Outcome
    Title Detection of Any Adenoma at the End of the Study Stratified by Putrescine Response and Treatment
    Description Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title Eflornithine and Sulindac + Putrescine Responders Eflornithine and Sulindac + Putrescine Nonresponders Placebo + Putrescine Responders Placebo + Putrescine Nonresponders
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline
    Measure Participants 61 60 46 72
    Yes
    9
    4.7%
    7
    3.8%
    22
    5.9%
    28
    NaN
    No
    52
    27.2%
    53
    28.8%
    24
    6.4%
    44
    NaN
    7. Secondary Outcome
    Title Detection of Any Adenoma at the End of the Study Stratified by Spermidine-to-spermine Ratio Response and Treatment
    Description Spermidine-to-spermine ratio responder = ratios at 36-month are decreased by >=30% from baseline Spermidine-to-spermine ratio nonresponder = ratios at 36-month are increased, or decreased by < 30% from baseline The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title Eflornithine and Sulindac + Spd:Spm Responders Eflornithine and Sulindac + Spd:Spm Nonresponders Placebo + Spd:Spm Responders Placebo + Spd:Spm Nonresponders
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Spd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies SpSpd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline
    Measure Participants 83 38 41 77
    Yes
    8
    4.2%
    8
    4.3%
    17
    4.5%
    33
    NaN
    No
    75
    39.3%
    30
    16.3%
    24
    6.4%
    44
    NaN
    8. Secondary Outcome
    Title Adverse Events With a Grade of 3 and Above
    Description Participants reported at least 1 adverse event with a grade of 3 and above, regardless if the event is defined as serious per protocol or other. Per protocol, not all grade 3 events are considered as serious events.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 191 184
    Number [participants]
    46
    24.1%
    37
    20.1%
    9. Secondary Outcome
    Title Baseline Putrescine by ODC Genotype
    Description ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title ODC1 AA/GA ODC1 GG
    Arm/Group Description Patients with AA or GA genotype Patients with GG genotype
    Measure Participants 101 125
    Median (Full Range) [nmol/mg protein]
    0.47
    0.56
    10. Secondary Outcome
    Title Baseline Spermidine by ODC Genotype
    Description ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title ODC1 AA/GA ODC1 GG
    Arm/Group Description Patients with AA or GA genotype Patients with GG genotype
    Measure Participants 101 125
    Median (Full Range) [nmol/mg protein]
    1.99
    2.17
    11. Secondary Outcome
    Title Baseline Spermine by ODC Genotype
    Description ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title ODC1 AA/GA ODC1 GG
    Arm/Group Description Patients with AA or GA genotype Patients with GG genotype
    Measure Participants 101 125
    Median (Full Range) [nmol/mg protein]
    6.82
    7.29
    12. Secondary Outcome
    Title At the End of the Study - Putrescine Response by ODC Genotype
    Description Putrescine responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) ≥ the threshold. Putrescine non-responder was defined as (tissue putrescine value at baseline - tissue putrescine value at the end of the study)/(tissue putrescine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30. ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title DFMO + Sulindac - GG DFMO + Sulindac - AA/GA Placebo - GG Placebo - AA/GA
    Arm/Group Description Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 58 40 43 49
    Responder
    26
    13.6%
    21
    11.4%
    12
    3.2%
    12
    NaN
    Non-Responder
    32
    16.8%
    19
    10.3%
    31
    8.3%
    37
    NaN
    13. Secondary Outcome
    Title At the End of the Study - Spermidine Response by ODC Genotype
    Description Spermidine responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) ≥ the threshold. Spermidine non-responder was defined as (tissue spermidine value at baseline - tissue spermidine value at the end of the study)/(tissue spermidine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30. ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title DFMO + Sulindac - GG DFMO + Sulindac - AA/GA Placebo - GG Placebo - AA/GA
    Arm/Group Description Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 58 40 43 49
    Responder
    25
    13.1%
    12
    6.5%
    15
    4%
    11
    NaN
    Non-Responder
    32
    16.8%
    28
    15.2%
    28
    7.5%
    38
    NaN
    14. Secondary Outcome
    Title At the End of the Study - Spermine Response by ODC Genotype
    Description Spermine responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) ≥ the threshold. Spermine non-responder was defined as (tissue spermine value at baseline - tissue spermine value at the end of the study)/(tissue spermine value at baseline) < the threshold. The thresholds range from 0.25 to 0.45 with an increment of 0.5. The below data are shown for the threshold of 0.30. ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title DFMO + Sulindac - GG DFMO + Sulindac - AA/GA Placebo - GG Placebo - AA/GA
    Arm/Group Description Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 58 40 43 49
    Responder
    7
    3.7%
    7
    3.8%
    18
    4.8%
    10
    NaN
    Non-Responder
    51
    26.7%
    33
    17.9%
    25
    6.7%
    39
    NaN
    15. Secondary Outcome
    Title Number of Participants Have Adenoma Recurrence in Each ODC1 Genotytpe by Treatment Group
    Description ODC genotype is the genotype of single nucleotide polymorphisms (SNP) in the ornithine decarboxylase (ODC) promoter The analysis cohort is based on the participants whose data are available and complete.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available and complete.
    Arm/Group Title DFMO + Sulindac - GG DFMO + Sulindac - AA/GA Placebo - GG Placebo - AA/GA
    Arm/Group Description Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 64 42 44 53
    Number [participants]
    7
    3.7%
    9
    4.9%
    22
    5.9%
    18
    NaN
    16. Secondary Outcome
    Title Biomarker in Adenoma: Apoptosis
    Description Apoptosis expression was assessed using cytoplasmic staining. The definitions for the category level for the Apoptosis are: 1. focal (less than 10% cells that are positively stained); 2. less than 50% cells are positively stained; 3. more than 50% cells are positively stained.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 11 38
    Measure adenoma 12 60
    A pattern equal to normal mucosa
    2
    4
    1.focal (<10%)
    7
    20
    2.cyto less than 50%
    1
    23
    3.cyto more than 50%
    2
    13
    17. Secondary Outcome
    Title Biomarker in Adenoma - Ki-67
    Description Estimated mean percent of cells staining postivie for the Ki-67 based on the GEE approach with adjustment for covariates
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 11 40
    Mean (95% Confidence Interval) [percentage of cells that are positive]
    59.5
    63.9
    18. Secondary Outcome
    Title Biomarker in Adenoma: CEA
    Description carcino-embryonic antigen (CEA) is adenocarcinoma tissue marker that is expressed during adenoma formation.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 11 40
    Measure Adenoma 12 66
    A pattern equal to normal mucosa
    1
    5
    1.<50% of cells showed staining
    5
    15
    2.50-90% of cells showed staining
    6
    35
    3.>90% of cells showed staining
    0
    9
    Insufficient tissue
    0
    2
    19. Secondary Outcome
    Title Biomarker in Adenoma: Sialyl-TN (B72.3)
    Description sialyl-Tn (B72.3) is adenocarcinoma tissue marker that is expressed during adenoma formation.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 11 40
    Measure Adenoma 12 66
    a pattern equal to normal mucosa
    3
    11
    1.<10% of the cells in the adenoma showed staining
    7
    32
    2.10-50% cells showed staining
    2
    17
    3.>50% cells showed staining
    0
    5
    Insufficient tissue
    0
    1
    20. Secondary Outcome
    Title Biomarker in Adenoma - p53
    Description Estimated mean percent of cells staining postivie for p53 based on GEE approach with adjument for covariates. Tumor protein p53, also known as p53, cellular tumor antigen p53, phosphoprotein p53, or tumor suppressor p53, is a protein that in humans is encoded by the TP53 gene.
    Time Frame At the end of the study

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 11 40
    Mean (95% Confidence Interval) [percentage of cells that are positive]
    75.6
    70.3
    21. Secondary Outcome
    Title Biomarker in Adenoma: Bcl-2
    Description bcl-2 is the anti-apoptotic protein BCL2
    Time Frame At the end of the study, up to 3 years

    Outcome Measure Data

    Analysis Population Description
    The analysis cohort is based on the participants whose data are available.
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    Measure Participants 11 40
    Measure Adenoma 12 66
    A pattern equal to normal mucosa
    4
    17
    1.<10% of the cells in the adenoma showed staining
    4
    25
    2.10-50% cells showed staining
    3
    14
    3.>50% cells showed staining
    1
    8
    Insufficient tissue
    0
    2

    Adverse Events

    Time Frame The adverse event onset date occurred between the date of run-in and the date of off-study or date of follow-up (up to 3.5 years), when available.
    Adverse Event Reporting Description
    Arm/Group Title Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Arm/Group Description Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. eflornithine: Given orally sulindac: Given orally laboratory biomarker analysis: Correlative studies Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. placebo: Given orally laboratory biomarker analysis: Correlative studies
    All Cause Mortality
    Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 41/191 (21.5%) 28/184 (15.2%)
    Cardiac disorders
    ACUTE MYOCARDIAL INFARCTION 2/191 (1%) 2 0/184 (0%) 0
    ANEURYSM 1/191 (0.5%) 1 0/184 (0%) 0
    ANGINA 0/191 (0%) 0 1/184 (0.5%) 1
    AORTIC STENOSIS 1/191 (0.5%) 1 0/184 (0%) 0
    CHEST PAIN 2/191 (1%) 2 1/184 (0.5%) 1
    CHEST PAIN AND PALPITATIONS 1/191 (0.5%) 1 0/184 (0%) 0
    CHEST PAIN X 3 WKS, R/O CORONARY ARTERY DISEASE 1/191 (0.5%) 1 0/184 (0%) 0
    CONGESTIVE HEART FAILURE 2/191 (1%) 2 0/184 (0%) 0
    CORONARY ARTERY DISEASE 3/191 (1.6%) 3 0/184 (0%) 0
    CORONARY ARTERY DISEASE POST NON-ST ELEVATION MI 0/191 (0%) 0 1/184 (0.5%) 1
    CORONARY ARTERY DISORDER 0/191 (0%) 0 1/184 (0.5%) 2
    DISCHARGE SUMMARY 1/27/02 NEW ONSET ATRIAL FIBRILLATION 0/191 (0%) 0 1/184 (0.5%) 1
    HEART DISEASE: A. CORONARY, B. NON-Q-WAVE INFARCTION, C. UNSTABLE ANGINA; CORONARY STENTING 1/191 (0.5%) 1 0/184 (0%) 0
    INFARCT MYOCARDIAL 1/191 (0.5%) 1 0/184 (0%) 0
    MYOCARDIAL INFARCTION/CHEST PAIN, ABNORMAL CARDIAC ENZYMES 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN CHEST 0/191 (0%) 0 1/184 (0.5%) 1
    QUADRUPLE BYPASS SURGERY FOR CAD, UNSTABLE ANGINA 1/191 (0.5%) 1 0/184 (0%) 0
    R/O MI 0/191 (0%) 0 1/184 (0.5%) 1
    STERNAL WOUND SURGICAL DEBRIDEMENT 1/191 (0.5%) 1 0/184 (0%) 0
    Endocrine disorders
    PARATHYROID DISORDER 1/191 (0.5%) 1 0/184 (0%) 0
    Gastrointestinal disorders
    ABDOMINAL PAIN MOST LIKELY SECONDARY TO ACUTE CHOLECYSTITIS 1/191 (0.5%) 1 0/184 (0%) 0
    COLITIS PSEUDOMEMBRANOUS 0/191 (0%) 0 1/184 (0.5%) 1
    DIVERTICULITIS 0/191 (0%) 0 1/184 (0.5%) 1
    GASTROINTESTINAL BLEEDING 1/191 (0.5%) 1 0/184 (0%) 0
    GASTROINTESTINAL BLEEDING SECONDARY TO ACUTE GASTROENTERITIS 0/191 (0%) 0 1/184 (0.5%) 1
    GI BLEED R/T DIVERTICULA 1/191 (0.5%) 1 0/184 (0%) 0
    HOSPITALIZATION; APPENDICITIS 1/191 (0.5%) 1 0/184 (0%) 0
    INTESTINAL ILEUS STATUS POST CHOLECYSTECTOMY 0/191 (0%) 0 1/184 (0.5%) 1
    OBSTRUCCTIVE JAUNDICE 1/191 (0.5%) 1 0/184 (0%) 0
    PT. ADMITTED TO HOSPITAL FOR SPIGELIAN HERNIA REPAIR 0/191 (0%) 0 1/184 (0.5%) 1
    RENAL CYST 0/191 (0%) 0 1/184 (0.5%) 1
    Hepatobiliary disorders
    CHOLECYSTITIS 1/191 (0.5%) 1 0/184 (0%) 0
    GALLSTONES, PANCREATITIS 0/191 (0%) 0 1/184 (0.5%) 1
    Infections and infestations
    PANCREATITIS 1/191 (0.5%) 2 1/184 (0.5%) 1
    SEPSIS 0/191 (0%) 0 1/184 (0.5%) 1
    URINARY TRACT INFECTION, HYPERGLYCEMIA 0/191 (0%) 0 1/184 (0.5%) 1
    UTI WITH SEPSIS 1/191 (0.5%) 1 0/184 (0%) 0
    Musculoskeletal and connective tissue disorders
    BROKEN RIGHT TIBIA UNDER KNEE D/T MVA 1/191 (0.5%) 1 0/184 (0%) 0
    FX (L) ELBOW 1/191 (0.5%) 1 0/184 (0%) 0
    HOSPITALIZATION; FRACTURE OF LEFT ANKLE REQUIRING SURGICAL INTERVENTION 1/191 (0.5%) 1 0/184 (0%) 0
    JOINT DISORDER 0/191 (0%) 0 1/184 (0.5%) 1
    LUMBAR HERNIATED DISC AND LUMBAR RADICULOPATHY 1/191 (0.5%) 1 0/184 (0%) 0
    MVA 1/191 (0.5%) 1 0/184 (0%) 0
    PT WAS IN A MOTOR VEHICLE ACCIDENT…RECEIVED CONTUSIONS AND EXPERIENCED HEAD PAIN. PT WAS RESTRAINED. 0/191 (0%) 0 1/184 (0.5%) 1
    RIGHT HIP PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    RIGHT KNEE PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    S/P LEFT TOTAL HIP ARTHROSCOPY 0/191 (0%) 0 1/184 (0.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CARCINOMA PROSTATIC 1/191 (0.5%) 1 0/184 (0%) 0
    HOSPITALIZATION FOR PANCREATIC NEOPLASM 1/191 (0.5%) 1 0/184 (0%) 0
    PANCREATIC CANCER 0/191 (0%) 0 1/184 (0.5%) 1
    Nervous system disorders
    BENIGN POSITIONAL VERTIGO 0/191 (0%) 0 1/184 (0.5%) 1
    CEREBRAL INFARCTION 1/191 (0.5%) 1 0/184 (0%) 0
    CEREBROVASCULAR ACCIDENT 0/191 (0%) 0 1/184 (0.5%) 1
    PROBABLE RIGHT SUBCORTICAL INFARCT 1/191 (0.5%) 1 0/184 (0%) 0
    SEIZURE ACTIVITY SECONDARY TO CEREBRAL ATROPHY OF RIGHT TEMPORAL LOBE 0/191 (0%) 0 1/184 (0.5%) 1
    Psychiatric disorders
    BIPOLAR, EXACERBATED 1/191 (0.5%) 1 0/184 (0%) 0
    DEPRESSION SUICIDAL 0/191 (0%) 0 1/184 (0.5%) 1
    MENTAL AND PHYSICAL BREAKDOWN 1/191 (0.5%) 1 0/184 (0%) 0
    Renal and urinary disorders
    BLADDER PROLAPSE 0/191 (0%) 0 1/184 (0.5%) 1
    HOSPITALIZATION - OVERNIGHT OBSERVATION; LEFT KIDNEY BIOPSY 1/191 (0.5%) 1 0/184 (0%) 0
    HOSPITALIZATION UTI 1/191 (0.5%) 1 0/184 (0%) 0
    HOSPITALIZED FOR ELECTIVE BLADDER SURGERY TO EVALUATE INCONTINENCE AND BIOPSY POSSIBLE TUMOR. 0/191 (0%) 0 1/184 (0.5%) 1
    KIDNEY CALCULUS 1/191 (0.5%) 1 0/184 (0%) 0
    NEPHROPATHY TOXIC 0/191 (0%) 0 1/184 (0.5%) 1
    RENAL FAILURE ACUTE 0/191 (0%) 0 1/184 (0.5%) 1
    Reproductive system and breast disorders
    DUCTAL LEFT BREAST CANCER 0/191 (0%) 0 1/184 (0.5%) 1
    HOSPITALIZATION VAGINAL BLEEDING TOTAL HYSTERECTOMY 1/191 (0.5%) 1 0/184 (0%) 0
    HOSPITALIZATION; BENIGN PROSTATIC HYPERTROPHY; ADMITTED FOR TRANSURETHRAL RESECTION OF THE PROSTATE 0/191 (0%) 0 1/184 (0.5%) 1
    LEFT URETERAL STONES, OBSTRUCTING 1/191 (0.5%) 1 0/184 (0%) 0
    PROLAPSED CYSTOCELE; TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY 1/191 (0.5%) 1 0/184 (0%) 0
    PROSTATE CANCER 0/191 (0%) 0 1/184 (0.5%) 1
    Respiratory, thoracic and mediastinal disorders
    ACUTE SHORTNESS OF BREATH R/T CHF, IMPROVED 1/191 (0.5%) 1 0/184 (0%) 0
    ACUTE SHORTNESS OF BREATH; CAD; UNSTABLE ANGINA 1/191 (0.5%) 1 0/184 (0%) 0
    ARRYTHMIA SINUS 1/191 (0.5%) 1 0/184 (0%) 0
    COPD EXACERBATION 0/191 (0%) 0 1/184 (0.5%) 1
    DYSPNEA 0/191 (0%) 0 1/184 (0.5%) 1
    MALIGNANT EPITHELOID NEOPLASM 0/191 (0%) 0 1/184 (0.5%) 1
    PNEUMONIA 1/191 (0.5%) 1 0/184 (0%) 0
    PNEUMONIA, SEPSIS SYNDROME, ACUTE RENAL FAILURE 0/191 (0%) 0 1/184 (0.5%) 1
    PNEUMONIA; POSSIBLE COPD EXACERBATION 1/191 (0.5%) 1 0/184 (0%) 0
    Skin and subcutaneous tissue disorders
    BASAL CELL CARCINOMA 1/191 (0.5%) 1 0/184 (0%) 0
    CELLULITIS 1/191 (0.5%) 1 0/184 (0%) 0
    CELLULITIS OF RIGHT LEG 1/191 (0.5%) 1 0/184 (0%) 0
    LEFT LEG CELLULITIS 1/191 (0.5%) 1 0/184 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm I (Eflornithine and Sulindac) Arm II (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 173/191 (90.6%) 154/184 (83.7%)
    Cardiac disorders
    A-FIB 0/191 (0%) 0 1/184 (0.5%) 1
    BLOOD IN STOOL SMALL DOT 1/191 (0.5%) 1 0/184 (0%) 0
    CAD 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* ALTERED LEFT VENTRICULAR DIASTOLIC FUNCTION 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* ATRIAL FIBRILLATION 0/191 (0%) 0 2/184 (1.1%) 2
    CARDIAC* CONGESTIVE HEART FAILURE 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* DX -- POSSIBLE RETURN OF RENOVASCULAR HTN 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* DX WITH CAD 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* FLUID IN LUNGS 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* HEART ATTACK 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* HEART MURMUR 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* HEART PALPITATIONS AND HYPERTENSION 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* LEFT BUNDLE BRANCH BLOCK 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* MILD AORTIC SCLEROSIS 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* MYOCARDIAL INFARCTION BY EKG 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* NEAR FAINT EPISODES, DX HTN, ON DRUGS 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* PALPITATION 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* PALPITATIONS (PSVT) 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* TACHYCARDIA 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* TACHYCARDIA EPISODES - INCREASED FREQUENCY 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* UNSTABLE ANGINA, CHEST PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    CARDIAC* VALVULAR HEART DISEASE - MILVAL VALVE REGURGITATION 0/191 (0%) 0 1/184 (0.5%) 1
    CARDIAC* VASOVAGAL EPISODE 1/191 (0.5%) 2 0/184 (0%) 0
    CARDIAC* VASOVAGAL SYNCOPAL EPISODE 0/191 (0%) 0 1/184 (0.5%) 1
    CHEST PAIN RELATED TO 4/18 REPORT FOR HEART BURN 1/191 (0.5%) 1 0/184 (0%) 0
    CHEST PAIN WITH EXERTION 1/191 (0.5%) 1 0/184 (0%) 0
    DX CHF 0/191 (0%) 0 1/184 (0.5%) 1
    ELEVATED BLOOD PRESSURE 1/191 (0.5%) 1 0/184 (0%) 0
    HEART DISEASE 0/191 (0%) 0 1/184 (0.5%) 1
    HIGH BLOOD PRESSURE 1/191 (0.5%) 1 0/184 (0%) 0
    HTN 1/191 (0.5%) 1 0/184 (0%) 0
    HYPERTENSION 6/191 (3.1%) 7 6/184 (3.3%) 7
    HYPERTENSION /DIABETES 1/191 (0.5%) 1 0/184 (0%) 0
    HYPERTENSION MILD/MOD 1/191 (0.5%) 1 0/184 (0%) 0
    HYPERTENSION RETURNED 1/191 (0.5%) 1 0/184 (0%) 0
    HYPERTENSION SUSPECT OCULAR HYPERTENSION 1/191 (0.5%) 1 0/184 (0%) 0
    HYPERTENSION UNCONTROLLED 0/191 (0%) 0 1/184 (0.5%) 1
    INCREASE BP WITH RINGING IN EARS 0/191 (0%) 0 1/184 (0.5%) 1
    OCC. CHEST TIGHTNESS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* CLAUDICATION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ELEVATED BLOOD PRESSURE/ SINGLE EVENT 9/00 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ELEVATED BLOOD PRESSURE; SINGLE 9/00 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HTN 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HTN (R/T STRESS AND WEIGHT) 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* CHEST 2/191 (1%) 2 0/184 (0%) 0
    PAIN* CHEST DISCOMFORT 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* CHEST; EXACERBATION OF PREVIOUS CONDITION 1/191 (0.5%) 1 0/184 (0%) 0
    Ear and labyrinth disorders
    BLEEDING* EAR CANALS, LEFT AND RIGHT 0/191 (0%) 0 1/184 (0.5%) 1
    CHANGE 1/191 (0.5%) 1 0/184 (0%) 0
    CHANGE IN HEARING PER AUDIOGRAM 1/191 (0.5%) 1 0/184 (0%) 0
    CHANGE IN SIGNIFICANT OTHER'S PERCEPTION OF HEARING 1/191 (0.5%) 1 0/184 (0%) 0
    CN VIII 0/191 (0%) 0 1/184 (0.5%) 1
    EAR INFECTION 1/191 (0.5%) 1 2/184 (1.1%) 2
    HEARING 5/191 (2.6%) 5 5/184 (2.7%) 7
    HEARING "CARBONIZATION SOUND" - LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING /INNER EAR - "STATIC NOISE" LEFT 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDIO CHANGE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING AUDIO CHANGE SUBCLINICAL 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDIO SHOWS NO CHANGE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING AUDIOGRAM 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDIOGRAM CHANGE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING AUDIOGRAM GRADE 1 HEARING CHANGE 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDIOGRAM ONLY 2/191 (1%) 2 0/184 (0%) 0
    HEARING AUDIOMETIC CHANGE, OFF STUDY 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING AUDIOMETRIC CHANGE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING AUDIOMETRIC CHANGE BILATERAL 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDIOMETRIC CHANGE LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING AUDIOMETRIC CHANGE RIGHT EAR 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDIOMETRIC CHANGE RIGHT EAR/ OVERALL NO SIGNIFICANT CHANGE 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING AUDITORY 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING CHANGE 11/191 (5.8%) 13 6/184 (3.3%) 6
    HEARING CHANGE AUDIOGRAM 2/191 (1%) 2 1/184 (0.5%) 1
    HEARING CHANGE NOTED ON AUDIO 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING CHANGE PER AUDIOGRAM 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING CHANGE-LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING CHANGE? PT NOT SURE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING DECREASE IN HEARING 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING DECREASE IN HEARING ABILITY 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING DECREASE LEFT>RIGHT 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING DECREASED 1/191 (0.5%) 1 1/184 (0.5%) 1
    HEARING DECREASED RIGHT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING DIFFICULTY 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING HEARING CHANGE 3/191 (1.6%) 3 3/184 (1.6%) 3
    HEARING HEARING LOSS 2/191 (1%) 2 3/184 (1.6%) 3
    HEARING HEARING LOSS - SIGNIFICANT OTHER PERCEPTION 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING HEARING LOSS AUDIOMETRY ONLY 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING HEARNING LOSS/ SUBCLINICAL 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING HEARS PULSE IN LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING HUSBAND THINKS POSSIBLE HEARING CHANGE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING INNER EAR 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING LOSS 3/191 (1.6%) 3 2/184 (1.1%) 3
    HEARING LOSS (SELF-PERCEPTION) 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING LOSS + PAIN, LEFT NECK 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING LOSS - SIGNIFICANT OTHER PERCEPTION 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING LOSS IN LEFT EAR 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING LOSS IN LEFT EAR, AUDIO DONE 11-30-00 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING MILD LOSS 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING MUFFLED 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING OTITIS MEDIA 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING OTOTOXICITY 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING OTOTOXICITY - AUDIOGRAM ONLY 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING PLUGGED RIGHT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING POSSIBLE CHANGE 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING RIGHT EAR "PLUGGED" X2 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING RIGHT EAR PAIN/PLUG 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING RIGHT EAR PAIN/PLUG, EUSTACHIAN TUBE DYSFUNCTION 0/191 (0%) 0 1/184 (0.5%) 1
    HEARING SELF PERCEPTION 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING SELF PERCEPTION, DIFFICULTY WITH DISCRIMINATION 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING SLIGHT LOSS 1/191 (0.5%) 1 0/184 (0%) 0
    HEARING TINNITUS (HAS GOTTEN SLIGHTLY WORSE OVER LAST 2 MONTHS) 0/191 (0%) 0 1/184 (0.5%) 1
    LEFT EAR INFECTION, RINGING WITH FULLNESS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DISCOMFORT LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* EAR DISCHARGE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* EAR PAIN AND PRESSURE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RIGHT EAR PRESSURE 1/191 (0.5%) 1 0/184 (0%) 0
    OTOTOXICITY* LEFT EAR 1/191 (0.5%) 1 0/184 (0%) 0
    OTOTOXICITY* R/EAR CLOGGED 1/191 (0.5%) 1 0/184 (0%) 0
    OTOTOXICITY* TINNITUS LEFT EAR 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* EAR 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* EAR ACHE 1/191 (0.5%) 1 1/184 (0.5%) 1
    PAIN* EAR PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    RIGHT EAR SENSORAL HEARING LOSS -- AGE RELATED PER ENT MD 0/191 (0%) 0 1/184 (0.5%) 1
    RIGHT SIDE ABOVE EAR 1/191 (0.5%) 1 0/184 (0%) 0
    SIGNIFICANT OTHER PERCEPTION OF CHANGE IN HEARING 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS 12/191 (6.3%) 12 8/184 (4.3%) 11
    TINNITUS - SLIGHT INTERFERRENCE 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS CHRONIC 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS INCREASE 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS INCREASE, LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS INCREASED 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS INCREASED, LEFT EAR 1/191 (0.5%) 1 0/184 (0%) 0
    TINNITUS LEFT EAR 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS MAY HAVE INCREASED 1/191 (0.5%) 1 0/184 (0%) 0
    TINNITUS MILD INCREASE, AUDIO AT 6M 0/191 (0%) 0 1/184 (0.5%) 1
    TINNITUS PRE-EXISTING - INCREASED 1/191 (0.5%) 1 0/184 (0%) 0
    TINNITUS VERY SLIGHT 1/191 (0.5%) 1 0/184 (0%) 0
    TINNITUS X1 EPISODE 1/191 (0.5%) 1 0/184 (0%) 0
    TINNITUS X4 EPISODES 0/191 (0%) 0 1/184 (0.5%) 1
    Endocrine disorders
    DIABETES NEW ONSET 0/191 (0%) 0 1/184 (0.5%) 1
    ENLARGED THYROID 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DECREASED THYROID FUNCTION, THIN HAIR, DECREASED TEMP, DRY SKIN 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DIABETES 2/191 (1%) 2 0/184 (0%) 0
    OTHER* DIABETIC NEUROPATHY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DX OF DIABETES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ENDOCRINE -- HOT FLASHES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SMALL GOITER 0/191 (0%) 0 1/184 (0.5%) 1
    Eye disorders
    BIL. CATARACTS 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING IN EYE FROM THORN 1/191 (0.5%) 1 0/184 (0%) 0
    CATARACT SURGERY RIGHT EYE 0/191 (0%) 0 1/184 (0.5%) 1
    DRY EYE 0/191 (0%) 0 1/184 (0.5%) 1
    FUZZY EYESIGHT 0/191 (0%) 0 1/184 (0.5%) 1
    HEMIANOPSIA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER CONJUNCTIVITIS, WITH OP EYE SURGERY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BLEPHARITIS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* CONJUNCTIVITIS (ALLERGIC) 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DRY EYES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* EPISCLERITIS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* FLOATER D/T DIABETIC RETINOPATHY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* GLAUCOMA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GLAUCOMA INCREASED 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ITCHY EYES 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* OCULAR - DRY MACULAR DEGENERATION 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* OCULAR - INCREASE INTRAOCULAR PRESSURE LEFT EYE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* OCULAR/VISUAL MYOPIA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* REDDENED EYES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RETINA EDEMA, POST OP 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RETINAL TEAR LEFT EYE 0/191 (0%) 0 1/184 (0.5%) 2
    OTHER* RIGHT EYE BLURRINESS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* SUBORBITAL EDEMA, RIGHT EYE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* TEARY/WATERY EYES 0/191 (0%) 0 1/184 (0.5%) 1
    PSEDOTUMOR EYE WILL F/U IN 6 MONTHS 0/191 (0%) 0 1/184 (0.5%) 1
    SUBCONJUNCTIVAL HEMORRHAGE 1/191 (0.5%) 1 0/184 (0%) 0
    VISION 0/191 (0%) 0 2/184 (1.1%) 2
    VISION BLURRED 1/191 (0.5%) 1 0/184 (0%) 0
    VISION BLURRED RIGH EYE 0/191 (0%) 0 1/184 (0.5%) 1
    VISION BLURRED WHEN READING 0/191 (0%) 0 1/184 (0.5%) 1
    VISION BLURRING 0/191 (0%) 0 1/184 (0.5%) 1
    VISION CATARACT 1/191 (0.5%) 1 0/184 (0%) 0
    VISION CATARACT LEFT EYE 0/191 (0%) 0 1/184 (0.5%) 1
    VISION CATARACTS, "FLASHING LIGHT" 1/191 (0.5%) 1 0/184 (0%) 0
    VISION DISTURBANCE 1/191 (0.5%) 1 0/184 (0%) 0
    VISION FLASHING LIGHTS - BILATERAL 0/191 (0%) 0 1/184 (0.5%) 1
    VISION FLOATERS - LEFT EYE 0/191 (0%) 0 1/184 (0.5%) 1
    VISION FLOATERS, RIGHT EYE 1/191 (0.5%) 1 0/184 (0%) 0
    VISION GLAUCOMA 1/191 (0.5%) 1 0/184 (0%) 0
    VISION INCREASED INTRAOCULAR PRESSURE 0/191 (0%) 0 1/184 (0.5%) 1
    VISION LEFT EYE BLURRY 0/191 (0%) 0 1/184 (0.5%) 1
    VISION MYOPIA, LACERATION 0/191 (0%) 0 1/184 (0.5%) 1
    VISION RIGHT CATARACT 0/191 (0%) 0 1/184 (0.5%) 1
    VISION SUB-CONJUNCTIVAL HEMMORHAGE 1/191 (0.5%) 1 0/184 (0%) 0
    Gastrointestinal disorders
    ABDOMINAL PAIN 4/191 (2.1%) 6 5/184 (2.7%) 5
    ABDOMINAL PAIN ABD CRAMPING AND BLOAT 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN ABD. CRAMP AND CONSTIPATION 1/191 (0.5%) 2 0/184 (0%) 0
    ABDOMINAL PAIN ABDOMINAL CRAMPING 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN CRAMPING 2/191 (1%) 2 0/184 (0%) 0
    ABDOMINAL PAIN CRAMPS/ CONSTIPATION 1/191 (0.5%) 2 0/184 (0%) 0
    ABDOMINAL PAIN DIARRHEA X 1-2 DAILY, CRAMPING 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN DIARRHEA X 3-4 DAILY, CRAMPING 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN EPIGASTRIC PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN LEFT SIDE 2/191 (1%) 2 0/184 (0%) 0
    ABDOMINAL PAIN LOWER ABDOMEN, INTERMITTENT 0/191 (0%) 0 1/184 (0.5%) 1
    ABDOMINAL PAIN LOWER ABDOMINAL CRAMPING AFTER COLONOSCOPY 0/191 (0%) 0 1/184 (0.5%) 1
    ABDOMINAL PAIN OCCASIONAL ABD CRAMP WITH LOOSE STOOL WHEN NERVIOUS 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN STOMACH CRAMPS 1/191 (0.5%) 1 0/184 (0%) 0
    ABDOMINAL PAIN UPSET STOMACH 0/191 (0%) 0 1/184 (0.5%) 1
    BLACK STOOLS (THINKS FROM MAALOX) 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING GUMS DURING DENTAL VISIT 0/191 (0%) 0 2/184 (1.1%) 2
    BLEEDING RECTAL 7/191 (3.7%) 12 5/184 (2.7%) 6
    BLEEDING RECTAL 4 EPISODES BRBPR 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING RECTAL BRB TOILET PAPER 0/191 (0%) 0 1/184 (0.5%) 2
    BLEEDING RECTAL HEMORRHOIDS 5/191 (2.6%) 5 2/184 (1.1%) 2
    BLEEDING* HEMATOCHEZIA 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING* UPPER GI BLEED 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING, RECTAL 2/191 (1%) 2 0/184 (0%) 0
    BLOOD IN STOOL 4/191 (2.1%) 4 0/184 (0%) 0
    BLOOD IN STOOL /HEMORRHOID 1/191 (0.5%) 1 0/184 (0%) 0
    BLOOD IN STOOL BURGUNDY 1/191 (0.5%) 1 0/184 (0%) 0
    BLOOD IN STOOL DIARRHEA, CRAMPING, BLACK STOOL 0/191 (0%) 0 1/184 (0.5%) 1
    BLOOD IN STOOL DX: COLITIS 0/191 (0%) 0 1/184 (0.5%) 1
    BLOOD IN STOOL OCCULT 1/191 (0.5%) 1 0/184 (0%) 0
    BLOOD WITH BM 0/191 (0%) 0 1/184 (0.5%) 1
    BOWEL MOVEMENT REGULARITY CONTINUES 0/191 (0%) 0 1/184 (0.5%) 1
    CONSTIPATION 6/191 (3.1%) 8 4/184 (2.2%) 7
    CONSTIPATION CHRONIC 0/191 (0%) 0 1/184 (0.5%) 1
    CONSTIPATION GETTING WORSE 1/191 (0.5%) 1 0/184 (0%) 0
    CONSTIPATION INCONTINENCE 0/191 (0%) 0 1/184 (0.5%) 1
    CONSTIPATION R/T IMMODIUM 0/191 (0%) 0 1/184 (0.5%) 1
    CRAMPING 1/191 (0.5%) 1 0/184 (0%) 0
    DIARRHEA 31/191 (16.2%) 49 29/184 (15.8%) 47
    DIARRHEA + ABDOMINAL CRAMPS 1/191 (0.5%) 1 0/184 (0%) 0
    DIARRHEA 2 EPISODES 0/191 (0%) 0 1/184 (0.5%) 1
    DIARRHEA 3 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    DIARRHEA AFTER COLONOSCOPY 0/191 (0%) 0 1/184 (0.5%) 1
    DIARRHEA CONTINUED DIARRHEA 0/191 (0%) 0 1/184 (0.5%) 1
    DIARRHEA LOOSE STOOL 0/191 (0%) 0 1/184 (0.5%) 1
    DIARRHEA LOOSER STOOL 1/191 (0.5%) 1 0/184 (0%) 0
    DIARRHEA MILD 1/191 (0.5%) 1 0/184 (0%) 0
    DIARRHEA OCCASIONAL 1/191 (0.5%) 1 1/184 (0.5%) 1
    DIARRHEA X 1 RELATED TO FOOD 1/191 (0.5%) 1 0/184 (0%) 0
    DIVERTICULITIS 1/191 (0.5%) 1 0/184 (0%) 0
    EARLY SATIETY 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN 8/191 (4.2%) 8 7/184 (3.8%) 8
    EPIGASTRIC PAIN 2-3 EPISODES PER WEEK 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN GAS PAINS 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN GAS X 1 PER MONTH 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN GASTRIC PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN GERD 1/191 (0.5%) 1 1/184 (0.5%) 1
    EPIGASTRIC PAIN GERD (INCREASE SYMPTOMS) 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN GERD, WORSENED, EST. START 1970 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN PAIN X 1 0/191 (0%) 0 1/184 (0.5%) 1
    EPIGASTRIC PAIN RIGHT SIDE 0/191 (0%) 0 1/184 (0.5%) 1
    FLATULENCE 0/191 (0%) 0 1/184 (0.5%) 1
    GASTRIC REFLUX 1/191 (0.5%) 1 0/184 (0%) 0
    GASTRITIS 1/191 (0.5%) 1 0/184 (0%) 0
    GI ABDOMINAL BLOATING 1/191 (0.5%) 1 0/184 (0%) 0
    GI BARRETT'S ESOPHAGUS 1/191 (0.5%) 1 0/184 (0%) 0
    GI BARRETT'S ESOPHAGUS/DYSPLASIA 0/191 (0%) 0 1/184 (0.5%) 1
    GI BLOATING 2/191 (1%) 2 0/184 (0%) 0
    GI BLOATING / GAS 1/191 (0.5%) 1 0/184 (0%) 0
    GI BLOATING/FEELING OF INCOMPLETE EVACUATION, CONSISTENT WITH IBS 0/191 (0%) 0 1/184 (0.5%) 1
    GI CECUM BIOPSY: EROSIM WITH CHRONIC INFLAMMATION, NON-SPECIFIC 1/191 (0.5%) 1 0/184 (0%) 0
    GI CONT. COLITIS SX 0/191 (0%) 0 1/184 (0.5%) 1
    GI CONT. ESOPHAGEAL IRRITATION 0/191 (0%) 0 1/184 (0.5%) 1
    GI ESOPHAGEAL FULLNESS RELATED TO GASTRO CIRCLAGE 1/191 (0.5%) 1 0/184 (0%) 0
    GI HEARTBURN 1/191 (0.5%) 1 3/184 (1.6%) 3
    GI HEARTBURN 1 - 2 EPISODES/WEEK 1/191 (0.5%) 1 0/184 (0%) 0
    GI HEARTBURN 4 EPISODES WEEKLY 1/191 (0.5%) 1 0/184 (0%) 0
    GI HEARTBURN 5-6 EPISODES/WEEK 0/191 (0%) 0 1/184 (0.5%) 1
    GI HEARTBURN 5-6- EPISODES/WEEK 0/191 (0%) 0 1/184 (0.5%) 1
    GI HEARTBURN X9 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    GI HEARTBURN, 1 EPISODE PER WEEK 1/191 (0.5%) 1 0/184 (0%) 0
    GI INCREASE IN GERD SYMPTOMS 1/191 (0.5%) 1 0/184 (0%) 0
    GI INCREASED GERD SX 0/191 (0%) 0 1/184 (0.5%) 1
    GI INFLAMMATION COLITIS 1/191 (0.5%) 1 0/184 (0%) 0
    GI PEPTIC ULCER DISEASE 0/191 (0%) 0 1/184 (0.5%) 1
    GI STOMACH CRAMPS 1/191 (0.5%) 1 0/184 (0%) 0
    GI UPPER GI PAIN/ACID REFLUX 1/191 (0.5%) 1 0/184 (0%) 0
    GI UPSET 0/191 (0%) 0 1/184 (0.5%) 1
    GI UPSET STOMACH 0/191 (0%) 0 2/184 (1.1%) 3
    GI UPSET STOMACH X 2 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    GI UPSET STOMACH X3 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    GUM SORENESS 0/191 (0%) 0 1/184 (0.5%) 2
    H. PYLORI +, STOMACH UPSET 1/191 (0.5%) 1 0/184 (0%) 0
    H.PYLORI +, DX IBS - CONSTIPATION 1/191 (0.5%) 1 0/184 (0%) 0
    HEARTBURN 1/191 (0.5%) 1 1/184 (0.5%) 2
    HEMMORRHOID 1/191 (0.5%) 1 0/184 (0%) 0
    HEMORRHOIDS 2/191 (1%) 2 3/184 (1.6%) 4
    HEMORRHOIDS FLARE-UP 0/191 (0%) 0 1/184 (0.5%) 1
    INCREASE "BURPING" 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASE FLATULENCE 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASE FREQ OF HEMORHOIDAL BLEEDING 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASE STOOL FREQUENCY 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASE STOOLING 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED BOWEL MOVEMENTS 0/191 (0%) 0 1/184 (0.5%) 1
    INCREASED FLATULENCE; ANAL INCONTINENCE 1/191 (0.5%) 2 0/184 (0%) 0
    INCREASED STOOLING 0/191 (0%) 0 1/184 (0.5%) 1
    INDIGESTION 4/191 (2.1%) 6 3/184 (1.6%) 3
    INDIGESTION DYSPEPSIA 0/191 (0%) 0 1/184 (0.5%) 1
    INDIGESTION EPIGASTRIC PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    INDIGESTION HEART BURN 1/191 (0.5%) 1 0/184 (0%) 0
    LICHEN PLANUS MOUTH + TONGUE 0/191 (0%) 0 1/184 (0.5%) 1
    LLQ ABDOMINAL PAIN WITH BM 0/191 (0%) 0 1/184 (0.5%) 1
    LOOSE STOOL 1/191 (0.5%) 1 2/184 (1.1%) 3
    NAUSEA 16/191 (8.4%) 18 11/184 (6%) 16
    NAUSEA 5 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    NAUSEA AFTER COLONOSCOPY 0/191 (0%) 0 1/184 (0.5%) 1
    NAUSEA AND BELCHING 1/191 (0.5%) 2 0/184 (0%) 0
    NAUSEA NAUSEA/DIARRHEA/HEADACHE 1/191 (0.5%) 3 0/184 (0%) 0
    NAUSEA POST SURGICAL 1/191 (0.5%) 1 0/184 (0%) 0
    NAUSEA RELATED TO NEW MEDICINE GLUCOPHAGE 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL HAD BUMP ON SURFACE OF TONGUE 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL SORE NEAR RIGHT INCISOR 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL SORENESS, UPPER RIGHT GUM WHERE PREVIOUSLY BAD TOOTH REMOVED 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL SORES 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* BLISTER ROOF OF MOUTH 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* CANKER SORES 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* CANKER SORES ON TONGUE 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* CHAPPED LIPS 1/191 (0.5%) 2 0/184 (0%) 0
    ORAL* COLD SORES, LIPS 3/191 (1.6%) 3 0/184 (0%) 0
    ORAL* DIFFICULTY SWALLOWING POSSIBLY DUE TO ROSACEA MEDS 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* DISCOLORING OF TEETH 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* DISCOMFORT MOUTH, POST DENTAL WORK 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* DRY MOUTH 1/191 (0.5%) 1 1/184 (0.5%) 1
    ORAL* DRY THROAT 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* DRY THROAT/MOUTH 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* DYSGEUSIA/TASTE DISTURBANCE 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* DYSPHAGIA 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* EXACERBATION/ LICHEN PLANUS 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* GINGIVITIS FROM TEETH SCALING 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* GUM PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* HYPERTROPHY, LUMP LEFT UPPER GUM 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* INCREASED SALIVA 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* INTERMITTENT ORAL ULCERS 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* LESION 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* LESION ON LOWER LIP 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* MOUTH DRYNESS 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* MOUTH SORE 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* MOUTH SORES 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* PAIN - SOFT PALATE POST SURGICAL 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* PAIN IN MOUTH POST PERIODONTAL SURGERY 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* PAIN RIGHT UPPER MOLAR 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* PRE-ABSCESS 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* SORE GUM - RIGHT 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* SORE THROAT 0/191 (0%) 0 4/184 (2.2%) 5
    ORAL* SORENESS 1/191 (0.5%) 1 1/184 (0.5%) 1
    ORAL* THROAT DRYNESS 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* THROAT IRRITATION 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* TOOTH PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    ORAL* ULCERS 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* ABDOMINAL BLOATING 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ANAL FISTULA 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* ANAL FISTULA, SURG REPAIR 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BLOATING 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BLOATING, HX IBS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* CRAMPING 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DIFFICULTY SWALLOWING(DYSPHAGIA) 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DYSPEPSIA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DYSPHAGIA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ERODED ESOPHAGUS/GERD 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ESOPHAGEAL SPASM 1/191 (0.5%) 2 1/184 (0.5%) 1
    OTHER* ESOPHAGEAL STRICTURE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ESOPHAGITIS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* FOOD POISONING 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* FOOD POISONING: DIARRHEA. VOMITTING 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* GASTRITIS, DEHYDRATION, RESPIRATORY TRACT INFECTION, FATIGUE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* GERD 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HARDER STOOLS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEARTBURN 7/191 (3.7%) 15 7/184 (3.8%) 9
    OTHER* HEARTBURN 2X WEEKLY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEARTBURN 3 TIMES A WEEK 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEARTBURN X 3 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HEARTBURN X5 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HEARTBURN, 3-4 EPISODES/WEEK 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEARTBURN, INCREASE? 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEME + X3 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HT OF GASTRIC ULCERS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* INCREASED GAS WITH EATING 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LOOSE SPHINCTER RECTURM-SEEPAGE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LOOSE STOOL 1/191 (0.5%) 1 1/184 (0.5%) 1
    OTHER* MOUTH COLD SORE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ORAL SORENESS; ABCESS LOWER GUM 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PERIANAL ABSCESS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PERIANAL SWELLING 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RECTAL MOISTNESS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RECTAL URGENCY 0/191 (0%) 0 1/184 (0.5%) 2
    OTHER* RECTOCELE, VAGINAL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* RIGHT INGUINAL HERNIA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* STOMACH CRAMPING 0/191 (0%) 0 1/184 (0.5%) 2
    OTHER* VERY LOOSE STOOL 0/191 (0%) 0 1/184 (0.5%) 4
    PAIN AND LOCAL SWELLING, UPPER LEFT MOLAR 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* GAS 1/191 (0.5%) 2 0/184 (0%) 0
    PAIN* PELVIC CRAMPING 0/191 (0%) 0 1/184 (0.5%) 8
    PAIN* RECTAL PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* STOMACH 0/191 (0%) 0 1/184 (0.5%) 2
    PAIN* TOOTH 1/191 (0.5%) 1 0/184 (0%) 0
    PROCTALGIA FUGAX 0/191 (0%) 0 1/184 (0.5%) 1
    PROTRUDING AND TENDER HEMORRHOIDS 1/191 (0.5%) 1 0/184 (0%) 0
    REFLUX 2/191 (1%) 2 3/184 (1.6%) 4
    REFLUX ACID 1/191 (0.5%) 1 0/184 (0%) 0
    REFLUX ACID REFLUX 0/191 (0%) 0 2/184 (1.1%) 2
    REFLUX ACID REFLUX 2-3 EPISODES/WK 0/191 (0%) 0 1/184 (0.5%) 1
    REFLUX ACID REFLUX DAILY 0/191 (0%) 0 1/184 (0.5%) 1
    REFLUX GASTRIC 0/191 (0%) 0 1/184 (0.5%) 1
    REFLUX GERD 1/191 (0.5%) 1 0/184 (0%) 0
    REFLUX GERD EPISODE 1/191 (0.5%) 2 0/184 (0%) 0
    REFLUX GERD EPISODIC 1/191 (0.5%) 1 0/184 (0%) 0
    REFLUX GERD, INCREASED SEVERITY OF EPISODES 0/191 (0%) 0 1/184 (0.5%) 1
    REFLUX INCREASED GERD, NUMBER OF EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    RIGHT RENAL CYST 0/191 (0%) 0 1/184 (0.5%) 1
    SLIGHT QUEEZY STOMACH 1/191 (0.5%) 1 0/184 (0%) 0
    STOMACH ACHE 0/191 (0%) 0 1/184 (0.5%) 1
    STOMACH FLU 1/191 (0.5%) 1 0/184 (0%) 0
    STOMACH PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    STOMACH UPSET AND HEARTBURN 1/191 (0.5%) 2 0/184 (0%) 0
    STOMACH VIRUS (VIRAL GASTROECTERITIS) 1/191 (0.5%) 1 0/184 (0%) 0
    STOOL* BLACK 0/191 (0%) 0 1/184 (0.5%) 1
    STOOL* CLEAR RECTAL DISCHARGE 0/191 (0%) 0 1/184 (0.5%) 1
    STOOL* DISCOLORED 0/191 (0%) 0 1/184 (0.5%) 1
    STOOL* HARD 0/191 (0%) 0 1/184 (0.5%) 1
    STOOL* HIGHER FREQUENCY 1/191 (0.5%) 1 0/184 (0%) 0
    STOOL* LOOSE 2/191 (1%) 2 1/184 (0.5%) 1
    STOOL* LOOSE, 2-3 DAYS/WEEK 1/191 (0.5%) 1 0/184 (0%) 0
    STOOL* LOOSER 1/191 (0.5%) 1 0/184 (0%) 0
    STOOL* SOFT WITH ABDOMINAL CRAMPS 1/191 (0.5%) 1 0/184 (0%) 0
    STOOL* TARRY 1/191 (0.5%) 1 0/184 (0%) 0
    TOOTH ABCESS 1/191 (0.5%) 1 0/184 (0%) 0
    TOOTH INFECTION 0/191 (0%) 0 1/184 (0.5%) 1
    TOOTH INFECTION -> ROOT CANAL 1/191 (0.5%) 1 0/184 (0%) 0
    UPPER HARD PALATE 1 CM ERYTHEMA W/ ULCER 1/191 (0.5%) 1 0/184 (0%) 0
    VIRAL GASTROENTERITIS 0/191 (0%) 0 1/184 (0.5%) 1
    VOMITING 9/191 (4.7%) 9 5/184 (2.7%) 8
    VOMITING AND NAUSEA 0/191 (0%) 0 1/184 (0.5%) 1
    VOMITING NAUSEA AND VOMITING 1/191 (0.5%) 1 0/184 (0%) 0
    VOMITTING 0/191 (0%) 0 1/184 (0.5%) 1
    General disorders
    BIL LE EDEMA 1/191 (0.5%) 1 0/184 (0%) 0
    BIL SWOLLEN FEET AND ANKLES 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING* SHAVING 0/191 (0%) 0 1/184 (0.5%) 1
    COLD SYMPTOMS 11/191 (5.8%) 13 9/184 (4.9%) 11
    COLD SYMPTOMS COLD X3-4 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS HEAD 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS HEAD COLD 0/191 (0%) 0 6/184 (3.3%) 6
    FATIGUE 32/191 (16.8%) 34 17/184 (9.2%) 19
    FATIGUE* ALLERGY FATIGUE 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* BILATERAL LEG FATIGUE 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* DIAPHORESIS AFTER MEALS 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* INCREASED 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* MILD 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* MILD DEPRESSION 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* MUSCLE ACHES 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* POSSIBLE VIRUS 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* R/T MUSCLE WEAKNESS 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* RELATED TO MUSCLE WEAKNESS 0/191 (0%) 0 1/184 (0.5%) 1
    FATIGUE* SYNCOPE 1/191 (0.5%) 1 0/184 (0%) 0
    FATIGUE* WEAKNESS 1/191 (0.5%) 1 0/184 (0%) 0
    FEVER 2/191 (1%) 2 1/184 (0.5%) 1
    FEVER INTERMITTENT 1/191 (0.5%) 1 0/184 (0%) 0
    FEVER SWEATS 0/191 (0%) 0 1/184 (0.5%) 2
    FEVER X 2DAYS 1/191 (0.5%) 1 0/184 (0%) 0
    FEVER X1 1/191 (0.5%) 1 0/184 (0%) 0
    FLU 7/191 (3.7%) 7 3/184 (1.6%) 3
    FLU ACHY, NAUSEA, HEADACHE, COUGH 1/191 (0.5%) 1 0/184 (0%) 0
    FLU DIARRHEA N/V 1/191 (0.5%) 2 0/184 (0%) 0
    FLU FLU-LIKE SYMPTOMS 1/191 (0.5%) 1 0/184 (0%) 0
    FLU INFECTION 1/191 (0.5%) 1 0/184 (0%) 0
    FLU S/S 0/191 (0%) 0 1/184 (0.5%) 1
    FLU SYMPTOMS 1/191 (0.5%) 1 1/184 (0.5%) 1
    FLU X5 DAYS 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED FATIGUE 0/191 (0%) 0 1/184 (0.5%) 1
    LOWGRADE FEVER 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* + + PITTING BILATERAL ANKLE EDEMA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BAD COLD X 3 WKS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BILATERAL FOOT EDEMA R>L 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BILATERAL LOWER EXTREMEITY EDEMA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* CHILLS, JOINT PAIN, SKIN IS SENSITIVE 0/191 (0%) 0 1/184 (0.5%) 3
    OTHER* EDEMA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* EDEMA LEFT EXTREMITY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GENERAL ACHES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GENERAL BODY ACHES 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* INCREASED STRESS 1/191 (0.5%) 1 2/184 (1.1%) 2
    OTHER* LETHARGY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LOWER EXTREMITY EDEMA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* LOWER EXTREMITY EDEMA - BILATERAL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* SLEEPY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* STRESS, INCREASED 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    SWELLING PERIPHERAL EDEMA 1/191 (0.5%) 1 0/184 (0%) 0
    SWOLLEN ANKLES (PERIPHERAL EDEMA) 1/191 (0.5%) 1 0/184 (0%) 0
    Hepatobiliary disorders
    OTHER* GALLSTONES 0/191 (0%) 0 1/184 (0.5%) 1
    Immune system disorders
    OTHER* URTICARIA 0/191 (0%) 0 1/184 (0.5%) 1
    Infections and infestations
    BLEEDING* GUMS 0/191 (0%) 0 1/184 (0.5%) 1
    BROKEN TOOTH 1/191 (0.5%) 1 0/184 (0%) 0
    FEVER BLISTERS 0/191 (0%) 0 1/184 (0.5%) 1
    HERPES 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED ORAL HERPES OUTBREAKS 0/191 (0%) 0 1/184 (0.5%) 1
    INFECTION* BLADDER 0/191 (0%) 0 2/184 (1.1%) 2
    INFECTION* BLADDER INFECTION 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* EAR 0/191 (0%) 0 2/184 (1.1%) 2
    INFECTION* ESOPHAGITIS 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* EUSTACHIAN TUBES 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* FUNGAL FINGERNAIL 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* FUNGAL INFECTION FINGERNAILS 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* FUNGAL, LEFT MIDDLE FINGER 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* INFECTED SCROTAL CYST 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* INSECT BITE RIGHT ANKLE 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* LEFT INDEX FINGER 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* LEFT LOWER LEG AK SITE 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* LEFT TESTICLE 0/191 (0%) 0 1/184 (0.5%) 1
    INFECTION* MIDDLE EAR-BLOCKED EUSTACHIAN TUBE 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* PNEUMONIA POSS "SCAR" ON CXR 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* RIGHT BREAST 0/191 (0%) 0 1/184 (0.5%) 1
    INFECTION* RIGHT CALF BITE 0/191 (0%) 0 1/184 (0.5%) 2
    INFECTION* RIGHT MIDDLE FINGER NAIL 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* SINUS 3/191 (1.6%) 4 0/184 (0%) 0
    INFECTION* SINUS INFECTION 1/191 (0.5%) 1 0/184 (0%) 0
    INFECTION* SKIN FUNGAL 0/191 (0%) 0 1/184 (0.5%) 1
    INFECTION* TOOTH 2/191 (1%) 2 1/184 (0.5%) 2
    INFECTION* UPPER RESPIRATORY 0/191 (0%) 0 1/184 (0.5%) 1
    INFECTION* VAGINAL YEAST 1/191 (0.5%) 1 1/184 (0.5%) 1
    INFECTION* WOUND/INFECTION LEFT LE 0/191 (0%) 0 1/184 (0.5%) 1
    INFECTION* YEAST 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* YEAST INFECTION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HSV OUTBREAK 1/191 (0.5%) 2 0/184 (0%) 0
    POSSIBLE FUNGAL INFECTION (SCALP) 0/191 (0%) 0 1/184 (0.5%) 1
    TOE INFECTION 0/191 (0%) 0 1/184 (0.5%) 2
    Injury, poisoning and procedural complications
    CUT SHIN = INFECTION (CELLULITIS) 0/191 (0%) 0 1/184 (0.5%) 1
    FINGER LACERATION RIGHT HAND 1/191 (0.5%) 1 0/184 (0%) 0
    FOOT CONTUSION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* CUTS TAKE LONGER TO HEAL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LACERATION, ER VISIT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* MECHANICAL FALL WITH LACERATION 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PHLEBITIS LEFT FOREARM 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PHLEBITIS SUPERFICIAL LEFT FOREARM 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SPIDER BITE (LEG) SWELLING 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* SCORPION BITE RIGHT FOREARM 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* SHIN LACERATION 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* STERNAL PAIN/BURNING SENSATION 0/191 (0%) 0 1/184 (0.5%) 1
    WOUND INFECT 1/191 (0.5%) 1 0/184 (0%) 0
    WOUND* FACIAL CUT FROM FALL 0/191 (0%) 0 1/184 (0.5%) 1
    WOUND* HEAD LACERATION 0/191 (0%) 0 1/184 (0.5%) 1
    WOUND* HEAD LACERATION ON SCALP 0/191 (0%) 0 1/184 (0.5%) 1
    Investigations
    5 LBS X 2 WKS 0/191 (0%) 0 1/184 (0.5%) 1
    ABNORMAL X-RAY 1/191 (0.5%) 1 0/184 (0%) 0
    DECREASE HGB 5% FROM BASELINE 0/191 (0%) 0 1/184 (0.5%) 1
    DECREASE IN HGB 0/191 (0%) 0 1/184 (0.5%) 1
    DROP HGB 0/191 (0%) 0 1/184 (0.5%) 1
    DROP IN HGB 0/191 (0%) 0 1/184 (0.5%) 1
    ELECT. BALANCE 1/191 (0.5%) 1 0/184 (0%) 0
    ELEVATED CREATININE BUN 1/191 (0.5%) 2 0/184 (0%) 0
    ELEVATED LIVER ENZYMES 0/191 (0%) 0 1/184 (0.5%) 1
    ELEVATED PSA 0/191 (0%) 0 1/184 (0.5%) 1
    ELEVATED TRIGLYCERIDE 0/191 (0%) 0 1/184 (0.5%) 1
    ELEVATED TRIGLYCERIDES 571 0/191 (0%) 0 1/184 (0.5%) 1
    ELEVATED TRIGLYCERIDES 779 0/191 (0%) 0 1/184 (0.5%) 1
    HYPERGLICEMIA 1/191 (0.5%) 2 0/184 (0%) 0
    HYPERGLYCEMIA 1/191 (0.5%) 1 2/184 (1.1%) 2
    HYPERKALEMIA 2/191 (1%) 2 0/184 (0%) 0
    INCREASED ALKPHOSPHATASE 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED ALT 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED AST 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED BILIRUBIN 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED CREATININE 1/191 (0.5%) 1 0/184 (0%) 0
    INCREASED HEMOGLOBIN 0/191 (0%) 0 1/184 (0.5%) 1
    INCREASED LFTS 0/191 (0%) 0 1/184 (0.5%) 1
    LABS 10 % HGB DROP 0/191 (0%) 0 1/184 (0.5%) 1
    LABS 10% DROP HGB 1/191 (0.5%) 1 0/184 (0%) 0
    LABS 10% DROP HGB WITH DYSMENORRHEA 0/191 (0%) 0 1/184 (0.5%) 1
    LABS 10% DROP IN HGB 0/191 (0%) 0 1/184 (0.5%) 1
    LABS ANEMIA 2/191 (1%) 2 0/184 (0%) 0
    LABS ANEMIA - DROP IN HGB 0/191 (0%) 0 1/184 (0.5%) 2
    LABS ANEMIA, MENSUS DISORDER 0/191 (0%) 0 1/184 (0.5%) 1
    LABS ANEMIA: IRON DEFICIENCY 1/191 (0.5%) 1 0/184 (0%) 0
    LABS B-12 DEFICIENCY 1/191 (0.5%) 1 1/184 (0.5%) 1
    LABS BLOOD GLUCOSE ELEVATED 0/191 (0%) 0 1/184 (0.5%) 2
    LABS DECREASE HGB GREATER THAN 10% 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASE IN HGB 4/191 (2.1%) 4 4/184 (2.2%) 4
    LABS DECREASED HBG 10% FROM BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HBG OF 10% BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HEMOGLOBIN 0/191 (0%) 0 2/184 (1.1%) 2
    LABS DECREASED HEMOGLOBIN >10% 0/191 (0%) 0 1/184 (0.5%) 1
    LABS DECREASED HEMOGLOBIN NOT GREATER THAN 10% BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HEMOGLOBIN, REDRAW 12/4/01 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HGB 1/191 (0.5%) 1 1/184 (0.5%) 1
    LABS DECREASED HGB GREATER THAN 10% BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HGB GREATER THAN 10% FROM BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HGB, 10% FROM BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED HGB: CHRONIC 1/191 (0.5%) 1 0/184 (0%) 0
    LABS DECREASED NEUTROPHILS 0/191 (0%) 0 1/184 (0.5%) 1
    LABS DECREASED WBC 4/191 (2.1%) 4 0/184 (0%) 0
    LABS DROP IN HGB AND HEMATOCRIT 1/191 (0.5%) 1 0/184 (0%) 0
    LABS ELEVATED ALKALINE PHOSPHATASE 0/191 (0%) 0 1/184 (0.5%) 1
    LABS ELEVATED BILIRUBIN 1/191 (0.5%) 1 0/184 (0%) 0
    LABS ELEVATED PSA 1/191 (0.5%) 1 2/184 (1.1%) 2
    LABS ENDOCRINE: ELEVATED BLOOD GLUCOSE 1/191 (0.5%) 1 0/184 (0%) 0
    LABS HEMATURIA 3/191 (1.6%) 3 0/184 (0%) 0
    LABS HGB DECREASE = 10% 1/191 (0.5%) 1 0/184 (0%) 0
    LABS HGB DECREASE GREATER THAN 10% 1/191 (0.5%) 1 0/184 (0%) 0
    LABS HGB DROP 10% 1/191 (0.5%) 2 0/184 (0%) 0
    LABS HIGH ALT 0/191 (0%) 0 1/184 (0.5%) 1
    LABS HIGH AST 0/191 (0%) 0 1/184 (0.5%) 1
    LABS HIGH CHOLESTEROL LEVELS 0/191 (0%) 0 1/184 (0.5%) 1
    LABS HYPERCHOLESTEREMIA 0/191 (0%) 0 1/184 (0.5%) 1
    LABS HYPERKALEMIA 0/191 (0%) 0 1/184 (0.5%) 1
    LABS HYPERLIPIDEMIA 3/191 (1.6%) 3 0/184 (0%) 0
    LABS INCREASED ALKALINE PHOSPHATASE 0/191 (0%) 0 1/184 (0.5%) 1
    LABS INCREASED CHOLESTEROL 1/191 (0.5%) 1 0/184 (0%) 0
    LABS INCREASED GLUCOSE 0/191 (0%) 0 1/184 (0.5%) 1
    LABS INCREASED HGB A1C 0/191 (0%) 0 1/184 (0.5%) 1
    LABS LOW BLOOD SUGAR 0/191 (0%) 0 1/184 (0.5%) 1
    LABS LOW HEMOGLOBIN 0/191 (0%) 0 1/184 (0.5%) 1
    LABS LOW HEMOGLOBIN AFTER SURGERY 1/191 (0.5%) 1 0/184 (0%) 0
    LABS LOW HGB 1/191 (0.5%) 1 0/184 (0%) 0
    LABS LOW HGB - 10% FROM BASELINE 0/191 (0%) 0 3/184 (1.6%) 3
    LABS LOW HGB = 10% 1/191 (0.5%) 1 0/184 (0%) 0
    LABS LOWER WBC 0/191 (0%) 0 1/184 (0.5%) 1
    LABS PROTEINURIA 1/191 (0.5%) 5 0/184 (0%) 0
    LABS PSA ELEVATION 1/191 (0.5%) 1 0/184 (0%) 0
    LABS PSA LEVELS INCREASED (5 TO 8 TO 11) 1/191 (0.5%) 1 0/184 (0%) 0
    LABS WHITE BLOOD CELL COUNT DECREASED 0/191 (0%) 0 1/184 (0.5%) 1
    LABS WHITE BLOOD CELLS COUNT DOWN 1/191 (0.5%) 1 0/184 (0%) 0
    LOW BLOOD COUNT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* WHITE BLOOD CELL COUNT INCREASE 1/191 (0.5%) 1 0/184 (0%) 0
    SERUM GLUCOSE 1/191 (0.5%) 1 0/184 (0%) 0
    Metabolism and nutrition disorders
    ANOREXIA 8/191 (4.2%) 9 3/184 (1.6%) 6
    ANOREXIA DECREASED APPETITE 1/191 (0.5%) 1 0/184 (0%) 0
    ANOREXIA LOSS OF APPETITE 1/191 (0.5%) 1 0/184 (0%) 0
    APPETITE LOSS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DEHYDRATION 0/191 (0%) 0 1/184 (0.5%) 1
    WEIGHT LOSS 10/191 (5.2%) 13 5/184 (2.7%) 5
    WEIGHT LOSS >5% 1/191 (0.5%) 1 0/184 (0%) 0
    WEIGHT LOSS AND DIARRHEA 0/191 (0%) 0 1/184 (0.5%) 1
    WEIGHT LOSS DIETING 1/191 (0.5%) 1 0/184 (0%) 0
    WEIGHT LOSS DURING RUN-IN PERIOD 1/191 (0.5%) 1 0/184 (0%) 0
    WEIGHT LOSS INTENTIONAL 7/191 (3.7%) 7 4/184 (2.2%) 5
    WEIGHT LOSS ON DIET REGIMEN 0/191 (0%) 0 1/184 (0.5%) 1
    WEIGHT LOSS PURPOSEFUL 0/191 (0%) 0 1/184 (0.5%) 1
    WEIGHT LOSS R/T ATKINS DIET (10 LBS) 0/191 (0%) 0 1/184 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    ANKLE PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHIALGIA SHOULDER 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS ARTHRITIS FLARE UP - HANDS 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS BACK PAIN WORSENING 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS BILATERAL KNEE PAIN R/T 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS EXACERBATION OF GOUT 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS GOUT, RIGHT FOOT 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS HAND PAIN (ARTHRITIS) OR (FIBROMYALGIA EPISODE) 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS IN RIGHT KNEE 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS LEFT HAND JOINT PAIN R/T ARTHRITIS 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS LEFT KNEE/ LEFT WRIST 0/191 (0%) 0 1/184 (0.5%) 2
    ARTHRITIS LEFT WRIST 1/191 (0.5%) 1 1/184 (0.5%) 1
    ARTHRITIS NECK 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS OSTEO 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS OSTEOARTHRITIS-LEFT KNEE 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS OSTEOARTHRITIS-LEFT WRIST 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS R THUMB JOINT PAIN R/T 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS RIGHT ELBOW 0/191 (0%) 0 1/184 (0.5%) 1
    ARTHRITIS THUMB PAIN - ARTHRITIS BOTH HANDS 1/191 (0.5%) 1 0/184 (0%) 0
    ARTHRITIS TOE PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    BACK PAIN (MOTRIN USE) 0/191 (0%) 0 1/184 (0.5%) 1
    BACK PAIN, ON MOTRIN 1/191 (0.5%) 1 0/184 (0%) 0
    BACK STRAIN 1/191 (0.5%) 1 0/184 (0%) 0
    BROKE BACK 0/191 (0%) 0 1/184 (0.5%) 1
    BROKEN ANKLE 0/191 (0%) 0 1/184 (0.5%) 1
    BROKEN TOE 1/191 (0.5%) 1 0/184 (0%) 0
    DECREASED PERIPHERAL REFLEXES 1/191 (0.5%) 1 0/184 (0%) 0
    EXACERBATION OF LEFT KNEE PAIN - ARTHRALGIA 0/191 (0%) 0 1/184 (0.5%) 1
    FX RT GREAT TOE 1/191 (0.5%) 1 0/184 (0%) 0
    GOUT 1/191 (0.5%) 1 1/184 (0.5%) 1
    GROIN PULL 0/191 (0%) 0 1/184 (0.5%) 1
    HAND PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    HIP AREA 1/191 (0.5%) 1 0/184 (0%) 0
    HIP BURSITIS 1/191 (0.5%) 1 0/184 (0%) 0
    HIP PAIN 2/191 (1%) 2 0/184 (0%) 0
    JOINT 0/191 (0%) 0 1/184 (0.5%) 2
    JOINT PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    KNEE PAIN 2/191 (1%) 3 1/184 (0.5%) 1
    LEFT FLANK PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    LEFT KNEE 0/191 (0%) 0 2/184 (1.1%) 3
    LEG CRAMPS 0/191 (0%) 0 1/184 (0.5%) 1
    LEG PAIN 2/191 (1%) 2 0/184 (0%) 0
    LEG PAIN (RELATED TO HERNIATED DISC) 0/191 (0%) 0 1/184 (0.5%) 1
    LOW BONE DENSITY 1/191 (0.5%) 1 0/184 (0%) 0
    LOWBACK PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    LOWER BACK PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    LOWERBACK PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCLE SPASMS IN BACK 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL ACHE ARM LEFT 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL ACHINESS, TIGHTNESS - KNEES 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL ANKLE INJURY, LEFT, R/T MISSTEP 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL BACK PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL BACK SPASM 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL BACK STRAIN 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL BILATERAL LOWER EXTREMITY FATIGUE 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL BILATERAL THIGH CRAMPS 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL BUMP INTERIOR TO LEFT ELBOW 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL CRAMPS THIGH RIGHT 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL CRAMPS THIGHS BILATERAL 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL FOOT PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL INCREASED BACK PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL L2, L3 DISKS 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL LEFT HIP PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL LEFT INGUINAL HERNIA, RECURRENT 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL MINOR BACK PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL MUSCLE PAIN, RIGHT LEG 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL MUSCLE SORENESS - R FOREMARM 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL MUSCLE WEAKNESS/SORENESS 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL NECK PAIN FROM FALL 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL OLECRANON BURSITIS/CELLULITIS/ELBOW SWELLING 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL PAIN - BILATERAL KNEE 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL PAIN - RIGHT KNEE 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL RIGHT KNEE SWELLING 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL RIGHT KNEE TORN MENISCUS 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL RIGHT ROTATOR CUFF, PAIN JOINT FUNCTION 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL SCIATICA 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL SHOULDER PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL SHOULDER PAIN CONTINUES 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL SPRAINED ANKLE 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL TAILBONE INJURY 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL THIGH CRAMPS BILATERAL 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL TORN ROTATOR CUFF, LEFT 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL UNSTEADY GAIT 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL VENTRAL HERNIA X 2 0/191 (0%) 0 1/184 (0.5%) 1
    NECK AND SHOULDER PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    NECK PAIN 1/191 (0.5%) 1 1/184 (0.5%) 1
    NECK PAIN, INJURY 1/191 (0.5%) 1 0/184 (0%) 0
    OA PAIN (HIPS) 0/191 (0%) 0 1/184 (0.5%) 1
    OLECRANON BURSITIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ARTHRALGIA LEFT ANKLE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ARTHRALGIA LEFT ELBOW 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ARTHRALGIA LEFT SHOULDER 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ARTHRALGIA LEFT WRIST 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ARTHRALGIA LOWER BACK 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ARTHRALGIA NECK 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BACK PAIN AND DIARRHEA 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* BACK STRAIN 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* BODY ACHES 1/191 (0.5%) 1 1/184 (0.5%) 1
    OTHER* BODY ACHES GENERAL 0/191 (0%) 0 1/184 (0.5%) 2
    OTHER* BONE SPUR/HEEL PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BROKEN RIGHT UPPER ARM AND RIGHT FOOT R/T FALL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BURSITIS - SHOULDER 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* BURSITIS IN RIGHT SHOULDER 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BURSITIS RIGHT SHOULDER 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* BURSITIS-ELBOW 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* CARPAL TUNNEL SYNDROME BILATERAL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* COCCYX INJURY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DEGENERATIVE JOINT DISEASE-RIGHT GREAT TOE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DEGENERATIVE JOINT DISEASE; LOW BACK 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DISCOMFORT - RIGHT LEG 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DISCOMFORT LEFT KNEE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* KNEE STRAIN 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LEFT ARM FRACTURE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LEFT FOOT ARCH BRUISE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* MUCLE PULLED BACK 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* OSTEOPOROSIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* OSTEOPOROSIS-LEFT WRIST 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PAIN-LEFT ANKLE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PLANTAR FASCIITIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PLANTAR FASCIITIS LEFT FOOT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SORE SHOULDER RELATED TO PAST BREAK 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* STIFF FINGERS RIGHT. GOLF? 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* STRAIN LEFT ARM 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* TENDON, BRUISED RIGHT ELBOW 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN IN LOWER CALF 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* "VAGUE PAIN" WEAKNESS LEFT LEG 1/191 (0.5%) 2 0/184 (0%) 0
    PAIN* ALL OVER BODY 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* ANKLE 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* ARTHRALAGIA LEFT HAND 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* BACK 5/191 (2.6%) 5 2/184 (1.1%) 7
    PAIN* BACK INCREASING 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* BACK INTERMITTENT 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* BACK LOWER LEFT 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* BACK PAIN 4/191 (2.1%) 4 2/184 (1.1%) 2
    PAIN* BACK PAIN WHILE EXERCISING 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* BACK X2 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* BACK, MUSCLE SPASM 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* BILATERAL KNEE SORENESS 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* BILATERAL SHOULDER PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* BODY ACHES 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* CERVICAL - NECK 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* FINGER PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* FOOT PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* FOOT PAIN/SORE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* GENERAL MUSCLE/JOINT 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* GREAT TOE RIGHT 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* GREAT TOES PAINFUL 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* GROIN PAIN/ PUBIC BONE WITH LONG SITTING 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* HANDS JOINT 0/191 (0%) 0 1/184 (0.5%) 2
    PAIN* HEADACHE SINUS 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* HIPS/BACK 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* IN CHEST R/T FALL 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* IN FRONT OF LEFT UPPER THIGH 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* JOINTS INCREASING 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* JOINTS OF LEFT SIDE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* KNEE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* KNEE LIGAMENT 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* KNEE PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT ACHILLES 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT ANKLE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* LEFT ARM 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT ARM W/TINGLING 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT FOOT 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* LEFT HAND 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT HEEL 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT HEEL BONE SPUR 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* LEFT HIP 1/191 (0.5%) 1 3/184 (1.6%) 3
    PAIN* LEFT KNEE 1/191 (0.5%) 1 1/184 (0.5%) 1
    PAIN* LEFT LOWER EXTREMITY CLAUDICATION 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT NECK 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* LEFT SHOULDER 2/191 (1%) 2 0/184 (0%) 0
    PAIN* LEFT THUMB 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* LEG CRAMPS 0/191 (0%) 0 2/184 (1.1%) 2
    PAIN* LOW BACK 4/191 (2.1%) 4 4/184 (2.2%) 5
    PAIN* LOWER BACK STIFFNESS 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* MILD BACK PAIN "BURNING" 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* MUSCLE 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* MUSCLE ACHES 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* MUSCLE STRAIN (PAIN) IN LOWER BACK (OCCASIONAL) 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* MUSCLE STRAIN/SPASM 1/191 (0.5%) 2 0/184 (0%) 0
    PAIN* MVA - CHEST WALL PN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* MVA BACK PN/LEG PN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* NECK 1/191 (0.5%) 1 2/184 (1.1%) 2
    PAIN* NECK & BACK 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* NECK & UPPER CHEST PAIN 0/191 (0%) 0 1/184 (0.5%) 2
    PAIN* NECK, INJURY 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* PAIN IN LEFT LEG AND KNEE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* PULLED MUSCLE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT BACK PAIN, INJURY 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RIGHT BUTTOCKS 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT FLANK 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT GREAT TOE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT HEEL 3/191 (1.6%) 3 0/184 (0%) 0
    PAIN* RIGHT HEEL - PLANTAR FASCIITIS 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT HIP AND KNEE 1/191 (0.5%) 2 0/184 (0%) 0
    PAIN* RIGHT KNEE 1/191 (0.5%) 1 1/184 (0.5%) 1
    PAIN* RIGHT KNEE - INCREASE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT LEG PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT LOWER BACK 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RIGHT LOWER BACK AND LEFT KNEE PAIN 1/191 (0.5%) 2 0/184 (0%) 0
    PAIN* RIGHT LOWER BACK PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RIGHT SHOULDER 2/191 (1%) 2 2/184 (1.1%) 2
    PAIN* RIGHT SHOULDER BLADE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT SHOULDER PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RIGHT SIDED PAIN AFTER EXERCISE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* RLQ 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RT LEG SECONDARY TO FALL 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RUQ PAIN 0/191 (0%) 0 2/184 (1.1%) 2
    PAIN* SCIATICA 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* SHOULDERS 2/191 (1%) 2 0/184 (0%) 0
    PAIN* SORE KNEE 2/191 (1%) 2 0/184 (0%) 0
    PAIN* SORE LEFT BIG TOE - GOUT? 0/191 (0%) 0 1/184 (0.5%) 3
    PAIN* SORE LEFT SHOULDER 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* SORE ON THUMB 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* SORE RT. KNEE, INCREASED PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* SPRAINED ANKLE 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* STIFF NECK R/T HEAD BUMP IN BATH 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* STIFFNESS & PAIN IN WRIST 0/191 (0%) 0 1/184 (0.5%) 2
    PAIN* TAILBONE 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* UPPER RIGHT QUADRANT 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN/MUSCULOSKELETAL/SOFT TISSUE; EXTREMITY - UPPER LEFT SHOULDER ROTATOR CUFF TEAR REAPAIR 0/191 (0%) 0 1/184 (0.5%) 1
    RIGHT ANKLE PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    RIGHT ELBOW TENDONITIS 0/191 (0%) 0 1/184 (0.5%) 1
    RIGHT TELBOW TENDONITIS 0/191 (0%) 0 1/184 (0.5%) 1
    RT ELBOW FX 1/191 (0.5%) 1 0/184 (0%) 0
    SEVERE BACK PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    SHOULDER PAIN OLD INJURY FLAIR UP 0/191 (0%) 0 1/184 (0.5%) 1
    SPRAINED ANKLE 1/191 (0.5%) 1 0/184 (0%) 0
    TENDONITIS 0/191 (0%) 0 1/184 (0.5%) 1
    TMJ 0/191 (0%) 0 1/184 (0.5%) 1
    WEAKNESS 1/191 (0.5%) 1 2/184 (1.1%) 2
    WEAKNESS LEFT HAND 0/191 (0%) 0 1/184 (0.5%) 1
    WEAKNESS LOWER EXTREMITY 0/191 (0%) 0 1/184 (0.5%) 1
    WEAKNESS NEW - LEFT ARM 1/191 (0.5%) 1 0/184 (0%) 0
    WEAKNESS OVERALL 0/191 (0%) 0 1/184 (0.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CYST. DERMAL ON BACK 0/191 (0%) 0 1/184 (0.5%) 1
    EXCISED MASS 1/191 (0.5%) 1 0/184 (0%) 0
    MASS FOUND ON CRX 1/191 (0.5%) 1 0/184 (0%) 0
    MULTIPLE POLYPS (<4MM) IN FLEX SIGMOIDOSCOPY 0/191 (0%) 0 1/184 (0.5%) 1
    MULTIPLE POLYPS IN THE COLONOSCOPY 0/191 (0%) 0 1/184 (0.5%) 1
    MUSCULOSKELETAL GANGLION CYST 1/191 (0.5%) 1 0/184 (0%) 0
    MUSCULOSKELETAL MIDDLE FINGER CYST 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* 2 LUMPS IN GROIN AREA (SIZE 2 X 2 CM) 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ADENOMA POLYP 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BIOPSY OF SKIN NEOPLASM, ABD. CYST AND THIGH 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BLADDER POLYP 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BREAST LUMP (FNA NEG) 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* CYST IN GROIN WITH INFECTION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* CYST ON BACK, DRAINED 10/10/00 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* LEFT BREAST NODULE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* LESION ON RIGHT THIGH 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* LUMP IN RIGHT GROIN, LYMPHADENOPATHY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* LUNG CANCER LEFT HILAR MASS SQUAMOUS CELL LYMPH NODE THORAX 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PROSTATE CANCER 1/191 (0.5%) 1 1/184 (0.5%) 1
    OTHER* PROSTATIC ADENOCARCINOMA DX 7/01/03 BY BX 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SHADOW IN LEFT LUNG, POSS. BENIGN TUMOR OR SCAR TISSUE. CT 3/10/04 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* UTERINE POLYP 0/191 (0%) 0 1/184 (0.5%) 1
    Nervous system disorders
    BALANCE 4/191 (2.1%) 4 3/184 (1.6%) 3
    BALANCE BALANCE DISTURBANCE 2/191 (1%) 2 1/184 (0.5%) 2
    BALANCE BALANCE DISTURBANCE DUE TO B12 MALABSORPTION 0/191 (0%) 0 1/184 (0.5%) 1
    BALANCE DISTANCE DISTURBANCE 1/191 (0.5%) 1 0/184 (0%) 0
    BALANCE DISTURBANCE 4/191 (2.1%) 4 0/184 (0%) 0
    BELLS PALSY SIDE WEAKNESS 1/191 (0.5%) 1 0/184 (0%) 0
    CARPAL TUNNEL SYNDROM 0/191 (0%) 0 1/184 (0.5%) 1
    CENTRAL NERVOUS SYSTEM 1/191 (0.5%) 1 0/184 (0%) 0
    CENTRAL NERVOUS SYSTEM DEPRESSION 0/191 (0%) 0 1/184 (0.5%) 1
    CENTRAL NERVOUS SYSTEM HEADACHE RELATED TO CHOCOLATE 1/191 (0.5%) 1 0/184 (0%) 0
    CENTRAL NERVOUS SYSTEM INCREASE IN SEIZURES 1/191 (0.5%) 1 0/184 (0%) 0
    CENTRAL NERVOUS SYSTEM MEMORY LOSS 0/191 (0%) 0 1/184 (0.5%) 1
    CENTRAL NERVOUS SYSTEM MEMORY LOSS INCREASED 1/191 (0.5%) 1 0/184 (0%) 0
    CENTRAL NERVOUS SYSTEM MEMORY LOSS/FORGETFULNESS 0/191 (0%) 0 1/184 (0.5%) 1
    CENTRAL NERVOUS SYSTEM MEMORY PROBLEMS 1/191 (0.5%) 1 0/184 (0%) 0
    DIZZINESS 8/191 (4.2%) 11 8/184 (4.3%) 11
    DIZZINESS AFT CERUMEN REMOVAL 0/191 (0%) 0 1/184 (0.5%) 1
    DIZZINESS FELL R/T LIGHT HEADED 1/191 (0.5%) 1 0/184 (0%) 0
    DIZZINESS VERTIGO 0/191 (0%) 0 1/184 (0.5%) 1
    DIZZINESS/VERTIGO 1/191 (0.5%) 1 0/184 (0%) 0
    DIZZINESS/VERTIGO EPISODE LASTING LESS THAN 10 SEC 1/191 (0.5%) 1 0/184 (0%) 0
    HEADACHE 19/191 (9.9%) 22 18/184 (9.8%) 26
    HEADACHE INTERMITTENT 0/191 (0%) 0 1/184 (0.5%) 1
    HEADACHE NAUSEA 0/191 (0%) 0 1/184 (0.5%) 1
    HEADACHE PAIN 5 EPISODES 0/191 (0%) 0 1/184 (0.5%) 1
    HEADACHE PRESSURE 1/191 (0.5%) 1 0/184 (0%) 0
    HEADACHE SIDE 0/191 (0%) 0 1/184 (0.5%) 1
    HEADACHE SINUS PAIN 1/191 (0.5%) 1 0/184 (0%) 0
    HEADACHE WITH NAUSEA AND VOMITING 0/191 (0%) 0 1/184 (0.5%) 1
    HEADACHE WITH NAUSEA AND VOMITTING 0/191 (0%) 0 1/184 (0.5%) 1
    HEADACHE WITH VISION INVOLVEMENT 1/191 (0.5%) 1 0/184 (0%) 0
    HEADACHE X1 0/191 (0%) 0 1/184 (0.5%) 1
    INCREASED FREQUENCY OF DROPPING ITEMS 1/191 (0.5%) 1 0/184 (0%) 0
    MORE FREQUENT HEADACHES 0/191 (0%) 0 1/184 (0.5%) 1
    NEUROLOGY - DIZZINESS 1/191 (0.5%) 1 0/184 (0%) 0
    NEUROPATHY 0/191 (0%) 0 1/184 (0.5%) 1
    NEUROPATHY/SENSORY; TINGLING IN FINGERS 1/191 (0.5%) 1 0/184 (0%) 0
    NUMBNESS/TINGLING OF RIGHT ARM 1/191 (0.5%) 1 0/184 (0%) 0
    OCCULAR MIGRAIN 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ALTERED TASTE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ALTERED TASTE CHOCOLATE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BILATERAL FOOT TINGLING 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DYSGEUSIA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* FORGETFULNESS, LOSS OF TRAIN OF THOUGHT 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* INCREASE IN TREMORS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LAPSES IN CONCENTRATION 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LIGHTHEADEDNESS 0/191 (0%) 0 1/184 (0.5%) 2
    OTHER* MILD PARESTHESIA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* MILD PARESTHESIA, BILATERAL ARMS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* MODERATE PARESTHESIA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* MODERATE PARESTHESIA IN RIGHT HAND 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* NERVOUS REACTION 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* NUMBNESS LEFT PINNA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PARESTHESIA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PARESTHESIA GREAT TOE RIGHT 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PARESTHESIA TOES 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PARESTHESIA TOES LEFT FOOT 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PARESTHESIA-LEFT ARM 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SYNCOPE X 1 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* TINGLING LEFT FOOT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* TINGLING TONGUE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* UNSTEADY GAIT 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RT. RING FINGER, RT PINKY NUMBNESS/TINGLING 0/191 (0%) 0 1/184 (0.5%) 1
    PARKINSONS DISEASE 0/191 (0%) 0 1/184 (0.5%) 1
    PERIPHERAL NERVOUS SYSTEM* 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* ARMS TINGLE/GO NUMB 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* HAND TREMBLINGS 0/191 (0%) 0 1/184 (0.5%) 1
    PERIPHERAL NERVOUS SYSTEM* HAND TREMOR 0/191 (0%) 0 1/184 (0.5%) 1
    PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* MILD PARESTHESIA BOTH HANDS 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* NEURO SCIATIC RIGHT LEG 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* NEURO SCIATICA RIGHT LEG 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* OLD INJURY 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* PARESTHESIA 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* PARESTHESIA BILAT TINGLING IN SHOULDERS 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* PARESTHESIA L/HAND NUMBNESS 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* PARESTHESIA LEFT SHOULDER PINCHED NERVE 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* PERESTHESIA, FEET, INCREASED FROM BASELINE 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* RIGHT FOOT TOE NUMBNESS 1/191 (0.5%) 1 0/184 (0%) 0
    PERIPHERAL NERVOUS SYSTEM* RIGHT LEG NUMBNESS 0/191 (0%) 0 1/184 (0.5%) 1
    PERIPHERAL NERVOUS SYSTEM* SLIGHT TINGLING/NUMBNESS HANDS/WRIST 0/191 (0%) 0 1/184 (0.5%) 1
    PERIPHERAL NERVOUS SYSTEM* SPINAL STENOSIS 1/191 (0.5%) 1 0/184 (0%) 0
    SLEEP APNEA 1/191 (0.5%) 1 0/184 (0%) 0
    SPINNING 1/191 (0.5%) 1 0/184 (0%) 0
    TINGLING BIL THIGH TO CALVES. OCCURS ~2X/MO 0/191 (0%) 0 1/184 (0.5%) 1
    TINGLING IN FINGER TIPS (NEUROPATHYSENSORY) 1/191 (0.5%) 1 0/184 (0%) 0
    VERTIGO 5/191 (2.6%) 5 1/184 (0.5%) 1
    VERTIGO POSITIONAL 1/191 (0.5%) 1 0/184 (0%) 0
    VERTIGO SPINNING 0/191 (0%) 0 1/184 (0.5%) 1
    Psychiatric disorders
    ANXIETY 1/191 (0.5%) 1 4/184 (2.2%) 4
    ANXIETY AND DEPRESSION 1/191 (0.5%) 1 0/184 (0%) 0
    ANXIETY DEPRESSION 1/191 (0.5%) 2 0/184 (0%) 0
    ANXIETY INCREASED ANXIERTY AND BOREDOM 0/191 (0%) 0 1/184 (0.5%) 1
    ANXIETY MOOD SWINGS, HOT FLASHES, ANXIETY 1/191 (0.5%) 3 0/184 (0%) 0
    DEPRESSION 0/191 (0%) 0 2/184 (1.1%) 5
    DEPRESSION, MOM'S DEATH 1/191 (0.5%) 1 0/184 (0%) 0
    FEELING HEATED AFTER TAKING MEDICATION 1/191 (0.5%) 1 0/184 (0%) 0
    IRRITABILITY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DECREASED LIBIDO 1/191 (0.5%) 1 1/184 (0.5%) 1
    OTHER* DEPRESSION 1/191 (0.5%) 1 2/184 (1.1%) 2
    OTHER* DEPRESSION - RECURRANCE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DEPRESSIVE SX, RELATIONSHIP CONCERNS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* FEELS "FUZZY" IN HER HEAD 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GRIEF/DEPRESSION FM. DEATH 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEAD GETS COLD 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* INCREASE IN DEPRESSION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* INCREASED DEPRESSION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* INSOMNIA 3/191 (1.6%) 7 0/184 (0%) 0
    OTHER* INSOMNIA - TROUBLE SLEEPING 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* INSOMNIA INCREASE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* IRRITABILITY 0/191 (0%) 0 1/184 (0.5%) 1
    Renal and urinary disorders
    BLEEDING* BLOOD IN THE URINE 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING* BLOOD IN URINE 0/191 (0%) 0 3/184 (1.6%) 3
    BLEEDING* HEMATURIA 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING* HEMATURIA - TRACE 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING* HEMORRHAGE HEMATURIA 1/191 (0.5%) 2 0/184 (0%) 0
    BLOOD IN URINE 0/191 (0%) 0 1/184 (0.5%) 2
    GENITOURINARY - URINATING 1/191 (0.5%) 1 0/184 (0%) 0
    GENITOURINARY URINATING 1/191 (0.5%) 1 0/184 (0%) 0
    GLUCOSURIA 2/191 (1%) 2 0/184 (0%) 0
    HEMATARIA 1/191 (0.5%) 1 0/184 (0%) 0
    HEMATURIA-MICROSCOPIC 1/191 (0.5%) 1 0/184 (0%) 0
    HEMOGLOBINURIA 0/191 (0%) 0 1/184 (0.5%) 1
    KIDNEY PROBLEMS 1/191 (0.5%) 1 0/184 (0%) 0
    KIDNEY PROBLEMS/RENAL-OTHER 1/191 (0.5%) 1 0/184 (0%) 0
    KIDNEY STONE 0/191 (0%) 0 1/184 (0.5%) 1
    KIDNEY STONES 1/191 (0.5%) 1 0/184 (0%) 0
    LEFT KIDNEY STONE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* GENITOURINARY "TWINGE" RIGHT TESTICLE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GENITOURINARY BLADDER SPASMS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* GENITOURINARY, LEFT TESTICLE TENDER/SWOLLEN 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GENITOURINARY/ VAGINITIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GU - URINARY FREQUENCY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* GU BLADDER SPASMS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* IGA GLOMERULONEPHRITIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* INCONTINENCE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* INCREASED URINARY URGENCY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* INCREASING INCONTINENCE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* KIDNEY STONES 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* TURP 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* URGENCY TO URINATE WITH BURNING AT TIMES 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* URINARY RETENTION 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* URINARY URGENCY 1/191 (0.5%) 1 1/184 (0.5%) 1
    OTHER* URINATION PAIN 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN FROM KIDNEY STONES 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* FLANK PAIN, KIDNEY STONES 1/191 (0.5%) 1 0/184 (0%) 0
    POSSIBLE RENAL CALCULUS (TOOK 1 VICODINE) 1/191 (0.5%) 1 0/184 (0%) 0
    UTI 9/191 (4.7%) 9 7/184 (3.8%) 8
    UTI (BACK PN) 0/191 (0%) 0 1/184 (0.5%) 1
    UTI UTI SX 0/191 (0%) 0 1/184 (0.5%) 1
    Reproductive system and breast disorders
    ABNORMAL PSA 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING* PENILE 0/191 (0%) 0 1/184 (0.5%) 3
    BLEEDING* PROLONGED MENSTRUAL BLEEDING 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING* VAGINAL 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING* VAGINAL BLEED 1/191 (0.5%) 2 0/184 (0%) 0
    BPH 1/191 (0.5%) 1 0/184 (0%) 0
    BX - BPH 0/191 (0%) 0 1/184 (0.5%) 1
    ERECTILE DYSFUNCTION 0/191 (0%) 0 1/184 (0.5%) 1
    ERECTILE DYSFUNTION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DISCOMFORT POST PROSTATE BIOPSY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* DX METRORRHAGIA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* DYSPLASIA PROSTATE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ENLARGED PROSTATE, PT PLACED ON PROZOSIN 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ERECTILE DYSFUNCTION, INCREASED SEVERITY OVER TIME 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* IMPOTENCE 1/191 (0.5%) 1 1/184 (0.5%) 1
    OTHER* INCREASED PSA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* LEFT NIPPLE IRRITATED 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* MENOPAUSE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* OCCASIONAL LOSS OF ERECTION DURING INTERCOURSE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* VAGINAL ITCHING 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* BREAST TENDERNESS 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* LEFT TESTICLE 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* RIGHT BREAST 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* TESTICLE 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* TESTICULAR SORENESS & SWELLING 1/191 (0.5%) 2 0/184 (0%) 0
    SEXUAL DYSFUNCTION 0/191 (0%) 0 1/184 (0.5%) 1
    Respiratory, thoracic and mediastinal disorders
    ASTHMA 1/191 (0.5%) 1 0/184 (0%) 0
    ASTHMA FLARE-UP 1/191 (0.5%) 1 0/184 (0%) 0
    BLEEDING* EPITAXIS 0/191 (0%) 0 1/184 (0.5%) 1
    BLEEDING* NOSE BLEED 0/191 (0%) 0 1/184 (0.5%) 2
    BRONCHITIS 0/191 (0%) 0 2/184 (1.1%) 3
    BRONCHOSPASM 0/191 (0%) 0 1/184 (0.5%) 1
    COLD 2/191 (1%) 2 0/184 (0%) 0
    COLD SYMPTOMS COUGH AND COLD SYMPTOMS 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS DX SINUS INFECTION 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS NASAL CONGESTION 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS POST NASAL DRIP 0/191 (0%) 0 1/184 (0.5%) 1
    COLD SYMPTOMS SINUS DRAINAGE 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS SNIFFLES 1/191 (0.5%) 1 0/184 (0%) 0
    COLD SYMPTOMS SORE THROAT 0/191 (0%) 0 1/184 (0.5%) 1
    COLD SYMPTOMS WITH COUGH 1/191 (0.5%) 1 0/184 (0%) 0
    COLD WITH URI SX 1/191 (0.5%) 1 0/184 (0%) 0
    COLD/SINUS/EAR CONGESTION 1/191 (0.5%) 1 0/184 (0%) 0
    CONGESTION 0/191 (0%) 0 1/184 (0.5%) 1
    COUGH 0/191 (0%) 0 1/184 (0.5%) 1
    COUGH* 6/191 (3.1%) 7 5/184 (2.7%) 8
    COUGH* DRY 1/191 (0.5%) 1 0/184 (0%) 0
    DX WITH EMPHYSEMA 0/191 (0%) 0 1/184 (0.5%) 1
    DYSPNEA 1/191 (0.5%) 1 0/184 (0%) 0
    DYSPNEA (SHORTNESS OF BREATH) 1/191 (0.5%) 1 0/184 (0%) 0
    DYSPNEA ON EXERTION 1/191 (0.5%) 1 0/184 (0%) 0
    FLU-LIKE SYNDROME 0/191 (0%) 0 1/184 (0.5%) 1
    HEAD CONGESTION 1/191 (0.5%) 1 0/184 (0%) 0
    MUCUS/COUGHING 1/191 (0.5%) 1 0/184 (0%) 0
    NOSEBLEED 1/191 (0.5%) 1 0/184 (0%) 0
    ORAL* CONT. ESOPHAGEAL IRRITATION/SORE THROAT WITH DIFFICULTY SWALLOWING POSSIBLY DUE TO ROSACEA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ALLERGIC RHINITIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ALLERGIES 2/191 (1%) 5 2/184 (1.1%) 2
    OTHER* ALLERGY PET 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ALLERGY SYMPTOMS 1/191 (0.5%) 1 3/184 (1.6%) 5
    OTHER* BLOODY MUCOUS/ EXPECTORATED 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* COPD EXACERBATION 0/191 (0%) 0 1/184 (0.5%) 2
    OTHER* EMPHYSEMA 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* HEMOPTISIS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* INFECTION SINUS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* IRRITATED THROAT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* NASAL DISCHARGE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* POST NASAL DRIP 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RUNNY NOSE 1/191 (0.5%) 2 0/184 (0%) 0
    OTHER* SCRATCHY THROAT/SNIFFLES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SINUS INFECTION 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* SINUS PROBLEM 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SLEEP APNEA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SNIFFLES 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SOB CHEST TIGHTNESS, POSSIBLE GERD SX 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SORE THROAT 1/191 (0.5%) 1 4/184 (2.2%) 4
    OTHER* THROAT IRRITATION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* VOICE CHANGE - HOARSENESS 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* SORE THROAT 2/191 (1%) 2 0/184 (0%) 0
    POST NASAL DRIP 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY ALLERGIC RHINITIS 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY ALLERGIES/ASTHMA 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY ASTHMA FLARE UP 2/191 (1%) 2 0/184 (0%) 0
    RESPIRATORY ASTHMA FLARE-UP, WHEEZING, SOB 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY BRONCHIAL ASTHMA 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY BRONCHITIS 6/191 (3.1%) 6 3/184 (1.6%) 3
    RESPIRATORY CHEST COLD SX, DX WITH PNEUMONIA RIGHT LUNG 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY CHEST CRX, PNEUMONIA RIGHT LUNG 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY CHOKING ON SALIVA 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY CHRONIC RHINITIS CONTINUES 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY COLD 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY COLD SYMPTOMS 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY COLD SYMPTOMS: NASAL DRAINAGE, CONGESTION, COUGH 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY COPD EXACERBATION 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY COUGH 1/191 (0.5%) 1 2/184 (1.1%) 2
    RESPIRATORY DIAPHRAGM DISCOMFORT 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY DX WITH BRONCHIAL PNEUMONIA 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY DYSPNEA ON EXERTION 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY INFECTION, BRONCHITIS 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY PNEUMONIA 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY RHINITIS 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY SHORT OF BREATH 1/191 (0.5%) 1 1/184 (0.5%) 1
    RESPIRATORY SHORTNESS OF BREATH 1/191 (0.5%) 2 0/184 (0%) 0
    RESPIRATORY SHORTNESS OF BREATH 2X 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY SINUS INFECTION 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY SINUSITIS 1/191 (0.5%) 1 1/184 (0.5%) 1
    RESPIRATORY SOB 6 EPISODES 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY SOB WITH EXERTION 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY SOB WITH HEAVY EXERCISE 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY STUFFY NOSE 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY UPPER RESPIRATORY 0/191 (0%) 0 1/184 (0.5%) 1
    RESPIRATORY UPPER, INFLUENZA 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY UPPER, SINUS PROBLEM ALLERGY RELATED 1/191 (0.5%) 1 0/184 (0%) 0
    RESPIRATORY URI 0/191 (0%) 0 1/184 (0.5%) 1
    RINORRHEA 0/191 (0%) 0 1/184 (0.5%) 1
    SEASONAL ALLERGIES 1/191 (0.5%) 1 1/184 (0.5%) 2
    SHORTNESS OF BREATH 0/191 (0%) 0 1/184 (0.5%) 1
    SINUS CONGESTION 9/191 (4.7%) 9 2/184 (1.1%) 2
    SINUS CONGESTION & ALLERGIES 0/191 (0%) 0 1/184 (0.5%) 1
    SINUS CONGESTION ALLERGIES 1/191 (0.5%) 2 0/184 (0%) 0
    SINUS CONGESTION CONGESTION 0/191 (0%) 0 1/184 (0.5%) 1
    SINUS CONGESTION HEAD CONGESTION 0/191 (0%) 0 1/184 (0.5%) 1
    SINUS CONGESTION SINUS INFECTION 0/191 (0%) 0 1/184 (0.5%) 1
    SINUS CONGESTION SINUSITIS 1/191 (0.5%) 1 0/184 (0%) 0
    SINUS DISCOMFORT 0/191 (0%) 0 2/184 (1.1%) 2
    SINUS HEADACHE 0/191 (0%) 0 1/184 (0.5%) 1
    SINUS INFECTION 2/191 (1%) 2 3/184 (1.6%) 3
    SINUSITIS 1/191 (0.5%) 1 1/184 (0.5%) 1
    SORE THROAT 0/191 (0%) 0 1/184 (0.5%) 1
    SORE THROAT, COUGH, BODY ACHES, 103 TEMP 0/191 (0%) 0 1/184 (0.5%) 1
    SORE THROAT, MUCUS/COUGH 1/191 (0.5%) 1 0/184 (0%) 0
    STREP THROAT 0/191 (0%) 0 1/184 (0.5%) 1
    UPPER RESPIRATORY INFECTION 2/191 (1%) 3 1/184 (0.5%) 1
    URI 5/191 (2.6%) 5 7/184 (3.8%) 8
    URI CHEST CONGESTION/COUGH/PHLEGM 0/191 (0%) 0 1/184 (0.5%) 3
    URI COUGH AND SORE CHEST 0/191 (0%) 0 1/184 (0.5%) 1
    URI SINUS INFECTION/COUGH 0/191 (0%) 0 1/184 (0.5%) 1
    URI UPPER RESPIRATORY INFECTION 0/191 (0%) 0 1/184 (0.5%) 1
    WHEEZING W/ SWEATING SHORTNESS OF BREATH 0/191 (0%) 0 1/184 (0.5%) 2
    Skin and subcutaneous tissue disorders
    BASAL CELL SKIN LESION REMOVAL 1/191 (0.5%) 1 0/184 (0%) 0
    BASAL CELL TAKEN FROM FACE 0/191 (0%) 0 1/184 (0.5%) 1
    BRUISING LEFT HIP AREA 1/191 (0.5%) 1 0/184 (0%) 0
    CELLULITIS - LEFT BREAST WOUND - NON INFECTIOUS 0/191 (0%) 0 1/184 (0.5%) 1
    CELLULITIS LEF SIDE FACE 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* 2 SPOTS ON SCALP 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* ACTINIC KERATOSES REMOVED X3 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* ACTINIC KERATOSIS 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* ANAL SKIN TAG REMOVED 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* BASAL CELL CARCINOMA 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* BCC 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* BLACK SPOT CHANGES ON SCALP 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* BOIL 0/191 (0%) 0 1/184 (0.5%) 2
    DERMATOLOGY* BRUISES 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* BRUISING INTERMITTENT 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* DERMATITIS 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* DERMATITIS/ EXACERBATION THUMBS 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* DISCOVERY AND REMOVAL OF BENIGN SKIN LESION 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* DRY SKIN, FEET 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* EXTREME RASH ON TRUNK 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* FACIAL EDEMA 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* FUNGAL INF. 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* IMPETIGO (NOSE) 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* MELANOMA UPPER ARM MOLE SKIN EXCISION 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* PERIANA PRURITUS 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* PIGMENTATION SLOW TO FILL IN ON SCRAPE 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* PRURITUS 0/191 (0%) 0 1/184 (0.5%) 2
    DERMATOLOGY* R/O POSSIBLE SKIN CA SPOT SCHAGE COLOR AND SIZE, BX 2/12/04 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* RASH RIGHT ARM 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* REMOVAL SKIN CA 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* ROSACEA 1/191 (0.5%) 1 1/184 (0.5%) 1
    DERMATOLOGY* ROSACEA FLARE-UP 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* SKIN - BUMP, RED LEFT UPPER MOUTH 1/191 (0.5%) 1 0/184 (0%) 0
    DERMATOLOGY* SKIN - LESION RIGHT EAR ANTIHELIX 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* SKIN LESION 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* SKIN LESION ABOVE FOREHEAD 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* SKIN LESIONS (REMOVED) 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* SKIN RASH 0/191 (0%) 0 2/184 (1.1%) 2
    DERMATOLOGY* SKIN ROSACEA 0/191 (0%) 0 1/184 (0.5%) 1
    DERMATOLOGY* SKIN SENSITIVE TO SUN 0/191 (0%) 0 1/184 (0.5%) 1
    DIAPHORESIS ABDOMINAL DISCOMFORT 1/191 (0.5%) 1 0/184 (0%) 0
    ERYTHORMATOUS PLAQUES 1/191 (0.5%) 1 0/184 (0%) 0
    FORHEAD LESION REMOVAL 1/191 (0.5%) 1 0/184 (0%) 0
    ITCHING AND RASH TO RECTUM 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* 1 CM LESION ON RT. HAND 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ABCESS OF FINGER 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ACTINIC KERATOSIS REMOVED 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BASAL CELL CARCINOMA LEFT CLAVICLE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BASAL CELL CARCINOMA LEFT JAW 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BODY ODOR DIFFERENT 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BOIL ON COCCYX 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* CELLULITIS RIGHT KNEE 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* COLD SORE (NOSE) 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HOT AND SWEATY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* NAIL AVULSION, LEFT HALLUX NAIL 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* NIGHT SWEATS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* OCCASIONAL BRUISING 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PRURITIUS 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* PRURITIUS LEGS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PRURITIUS, HIPS AND BELLY 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PRURITUS, INTERMITTENT, BELLY, HIPS, LEGS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* PRURITUS, INTERMITTENT, HIPS 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* RECTAL BOIL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* RED LINE ON TOE 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* RIGHT GREAT TOE WITH REDDISH SPOT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* SKIN LESION LEFT FOREARM 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* ULCERATION, RT LOWER EXTREMITY 1/191 (0.5%) 1 0/184 (0%) 0
    RASH 4/191 (2.1%) 4 2/184 (1.1%) 2
    RASH ABDOMINAL 1/191 (0.5%) 1 0/184 (0%) 0
    RASH BODY AND EXTREMITIES 1/191 (0.5%) 1 0/184 (0%) 0
    RASH BUMPS ON SKIN 0/191 (0%) 0 1/184 (0.5%) 1
    RASH EXACERBATION OF SEASONAL ITCHY RASH 1/191 (0.5%) 1 0/184 (0%) 0
    RASH FACE 0/191 (0%) 0 1/184 (0.5%) 1
    RASH HANDS 0/191 (0%) 0 1/184 (0.5%) 1
    RASH ITCH 0/191 (0%) 0 1/184 (0.5%) 1
    RASH RIGHT CHEEK 1/191 (0.5%) 1 0/184 (0%) 0
    RASH RIGHT FOOTECZEMA 1/191 (0.5%) 1 0/184 (0%) 0
    RASH RIGHT FOREARM 1/191 (0.5%) 1 0/184 (0%) 0
    RASH RIGHT LEG 1/191 (0.5%) 1 0/184 (0%) 0
    RASH SHINGLES 0/191 (0%) 0 2/184 (1.1%) 2
    RASH SKIN RIGHT UPPER ARM 0/191 (0%) 0 1/184 (0.5%) 1
    RASH URTICARIA RIGHT BUTTOCK 1/191 (0.5%) 1 0/184 (0%) 0
    ROSACASE 1/191 (0.5%) 1 0/184 (0%) 0
    SHINGLES 1/191 (0.5%) 1 0/184 (0%) 0
    SKIN LESION REMOVED 0/191 (0%) 0 1/184 (0.5%) 1
    SKIN RASH 1/191 (0.5%) 1 0/184 (0%) 0
    SMALL OUTBREAKS OF PUSTULES UNDER NOSTRILS 0/191 (0%) 0 1/184 (0.5%) 1
    SQUAMOUS CELL REMOVAL 1/191 (0.5%) 1 0/184 (0%) 0
    Surgical and medical procedures
    HAND SURGERY - TRIGGER FINGER 1/191 (0.5%) 1 0/184 (0%) 0
    HERNIA REPAIR 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* BRACHY THERAPY FOR PROSTATE CA 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* BREAST BIOPSY 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* CHEST X-RAY ABNORMAL, RIGHT UPPER LOBE LESION 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* F/U 6MO CT 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* REMOVAL OF SHRAPNEL 0/191 (0%) 0 1/184 (0.5%) 1
    OTHER* ROOT CANAL X3 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* FROM SEED IMPLANT FOR PROSTATE CA 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* POST - SURGICAL 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* POST HERNIA REPAIR 0/191 (0%) 0 1/184 (0.5%) 1
    PAIN* POST ORAL SURGERY 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* POST ROOT CANAL 2/191 (1%) 3 0/184 (0%) 0
    PAIN* POST SURGICAL 1/191 (0.5%) 1 0/184 (0%) 0
    PAIN* POST TOOTH EXTRACTION 2/191 (1%) 2 0/184 (0%) 0
    RELEASE OF CARPAL TUNNEL IN RIGHT HAND 1/191 (0.5%) 1 0/184 (0%) 0
    REMOVAL OF PINS FROM PRIOR BUNIONECTOMY RIGHT FOOT 0/191 (0%) 0 1/184 (0.5%) 1
    REMOVAL PRE-CAN SK. 1/191 (0.5%) 2 0/184 (0%) 0
    SURGERY* CABG WOUNDS (CORONARY ARTERY BYPASS GRAFT) 1/191 (0.5%) 1 0/184 (0%) 0
    SURGERY* CHOLESYSTECTOMY 0/191 (0%) 0 1/184 (0.5%) 1
    SURGERY* DEVIATED SEPTUM & UVULECTOMY 0/191 (0%) 0 1/184 (0.5%) 1
    SURGERY* GUM SURGERY OUT PT 0/191 (0%) 0 1/184 (0.5%) 2
    SURGERY* HERNIA 1/191 (0.5%) 1 2/184 (1.1%) 2
    SURGERY* POSS BASAL CELL SKIN CANCER 0/191 (0%) 0 1/184 (0.5%) 1
    SURGERY* PROSTATE RESTRUCTURING-ELECTIVE 1/191 (0.5%) 1 0/184 (0%) 0
    SURGERY* RIGHT INGUINAL HERNIA REPAIR 1/191 (0.5%) 1 0/184 (0%) 0
    SURGERY* ROTATOR CUFF REPAIR 0/191 (0%) 0 1/184 (0.5%) 1
    SURGERY* TURP/HOSPITAL 1/191 (0.5%) 1 0/184 (0%) 0
    Vascular disorders
    HOT FLASHES 1/191 (0.5%) 1 0/184 (0%) 0
    LOWER LEG SWELLINGW 0/191 (0%) 0 1/184 (0.5%) 1
    LYMPHADENITIS RIGT NECK 1/191 (0.5%) 1 0/184 (0%) 0
    OTHER* HOT FLASHES, STOPPED HRT MEDS 0/191 (0%) 0 1/184 (0.5%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Dr. Frank Meyskens, Jr.
    Organization University of California, Irvine
    Phone 714-456-6310
    Email flmeyske@uci.edu
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00118365
    Other Study ID Numbers:
    • NCI-2009-00880
    • UCI 97-05
    • R01CA088078
    • NCT00005882
    First Posted:
    Jul 11, 2005
    Last Update Posted:
    Jan 22, 2015
    Last Verified:
    Feb 1, 2014