SAHA: Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT00691210
Collaborator
Merck Sharp & Dohme Corp. (Industry)
40
Enrollment
1
Location
8
Arms
81
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. The investigators want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.

Detailed Description

Subjects will be treated with vorinostat administered orally with daily dosing for 14 days of a 21-day treatment cycle in combination with niacinamide administered orally for 14 days in 21-day treatment cycle and etoposide administered intravenously on days 8,9 and 10 of a 21-day treatment cycle. Etoposide dose will be escalated until maximum tolerated dose (MTD) is determined.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Vorinostat in Combination With Niacinamide, and Etoposide for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

ArmIntervention/Treatment
Experimental: V/N: Level 1

Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg

Drug: Vorinostat
Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Experimental: V/N: Level 2

    Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Experimental: V/N: Level 3

    Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Experimental: V/N: Level 4

    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Experimental: V/N: Level 5

    Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Experimental: V/N/E: Level 1

    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Drug: Etoposide
    Dose escalation scheme (0, 25, 50, 100 mg/m2) Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."
    Other Names:
  • VP-16
  • Experimental: V/N/E: Level 2

    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Drug: Etoposide
    Dose escalation scheme (0, 25, 50, 100 mg/m2) Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."
    Other Names:
  • VP-16
  • Experimental: V/N/E: Level 3

    Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2

    Drug: Vorinostat
    Dose escalation scheme (400 mg) Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.
    Other Names:
  • SAHA
  • Drug: Niacinamide
    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg) Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.
    Other Names:
  • Nicotinamide
  • Drug: Etoposide
    Dose escalation scheme (0, 25, 50, 100 mg/m2) Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."
    Other Names:
  • VP-16
  • Outcome Measures

    Primary Outcome Measures

    1. The Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide [3 years]

    Secondary Outcome Measures

    1. The Greatest Number of Cycles Received in Each Treatment Group [up to 45 weeks]

      The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.

    2. The Number of Dose Delays and Reductions at the MTD [continuous]

    3. The Prevalence of Anti-tumor Activity [continuous]

    4. Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies [continuous]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's Disease (WHO criteria), for which they are unwilling or unable to undergo an autologous stem cell transplant

    2. Must have received first line chemotherapy. No upper limit to number of prior therapies

    3. Evaluable Disease

    4. Age >18 years

    5. Eastern Cooperative Oncology Group (ECOG) performance status <2

    6. Life expectancy of greater than 3 months

    7. Patients must have adequate organ and marrow function

    8. Adequate Contraception

    9. Ability to understand and the willingness to sign a written informed consent document

    Exclusion Criteria:
    1. Prior Therapy
    • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

    • Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 7 days prior to the start of the study drugs

    • No monoclonal antibody within 3 months unless evidence of progression

    1. Patients may not be receiving any other investigational agents

    2. Patients with known central nervous system metastases, including lymphomatous meningitis

    3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, niacinamide or etoposide

    4. Uncontrolled intercurrent illness

    5. Pregnant women

    6. Nursing women

    7. Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3 years

    8. Patient is known to be Human Immunodeficiency Virus (HIV)-positive

    9. Active Hepatitis A, Hepatitis B, or Hepatitis C infection

    10. Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Center for Lymphoid Malignancies at CUMCNew YorkNew YorkUnited States10019

    Sponsors and Collaborators

    • Columbia University
    • Merck Sharp & Dohme Corp.

    Investigators

    • Principal Investigator: Owen A O'Connor, MD, Ph.D., Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT00691210
    Other Study ID Numbers:
    • AAAJ3001
    First Posted:
    Jun 5, 2008
    Last Update Posted:
    Nov 20, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Columbia University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleV/N: Level 2V/N: Level 1V/N: Level 3V/N: Level 4V/N: Level 5V/N/E: Level 1V/N/E: Level 2V/N/E: Level 3
    Arm/Group DescriptionVorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme
    Period Title: Overall Study
    STARTED35395760
    COMPLETED35365660
    NOT COMPLETED00030100

    Baseline Characteristics

    Arm/Group TitleV/N: Level 1V/N: Level 2V/N: Level 3V/N: Level 4V/N: Level 5V/N/E: Level 1V/N/E: Level 2V/N/E: Level 3Total
    Arm/Group DescriptionVorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeTotal of all reporting groups
    Overall Participants5339576038
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    Between 18 and 65 years
    5
    100%
    2
    66.7%
    3
    100%
    7
    77.8%
    3
    60%
    6
    85.7%
    4
    66.7%
    30
    Infinity
    >=65 years
    0
    0%
    1
    33.3%
    0
    0%
    2
    22.2%
    2
    40%
    1
    14.3%
    2
    33.3%
    8
    Infinity
    Sex: Female, Male (Count of Participants)
    Female
    2
    40%
    2
    66.7%
    1
    33.3%
    4
    44.4%
    2
    40%
    2
    28.6%
    2
    33.3%
    15
    Infinity
    Male
    3
    60%
    1
    33.3%
    2
    66.7%
    5
    55.6%
    3
    60%
    5
    71.4%
    4
    66.7%
    23
    Infinity

    Outcome Measures

    1. Secondary Outcome
    TitleThe Greatest Number of Cycles Received in Each Treatment Group
    DescriptionThe highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.
    Time Frameup to 45 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleVorinostat (SAHA) and Niacinamide: Level 1Vorinostat (SAHA) and Niacinamide: Level 2Vorinostat (SAHA) and Niacinamide: Level 3Vorinostat (SAHA) and Niacinamide: Level 4Vorinostat (SAHA) and Niacinamide: Level 5Vorinostat, Niacinamide and Etoposide: Level 1Vorinostat, Niacinamide and Etoposide: Level 2
    Arm/Group DescriptionVorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme
    Measure Participants5336565
    Number [cycles]
    9
    12
    15
    10
    14
    3
    4
    2. Secondary Outcome
    TitleThe Number of Dose Delays and Reductions at the MTD
    Description
    Time Framecontinuous

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    TitleThe Prevalence of Anti-tumor Activity
    Description
    Time Framecontinuous

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    4. Secondary Outcome
    TitlePharmacodynamic Markers of Target Effect in Paired Tissue Biopsies
    Description
    Time Framecontinuous

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Primary Outcome
    TitleThe Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide
    Description
    Time Frame3 years

    Outcome Measure Data

    Analysis Population Description
    There were no evaluable patients at these levels.
    Arm/Group TitleVorinostat (SAHA) and Niacinamide: Level 1-5Vorinostat, Niacinamide and Etoposide: Level 1-2
    Arm/Group DescriptionVorinostat: 400mg Niacinamide: 20-100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25-50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme
    Measure Participants220
    Number [mg/kg]
    100

    Adverse Events

    Time FrameAdverse event data was collected up to 30 days post end of treatment for each patient
    Adverse Event Reporting Description Adverse events were collected by patient reporting and physical exam with an attending and graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
    Arm/Group TitleVorinostat (SAHA) and Niacinamide: Level 1Vorinostat (SAHA) and Niacinamide: Level 2Vorinostat (SAHA) and Niacinamide: Level 3Vorinostat (SAHA) and Niacinamide: Level 4Vorinostat (SAHA) and Niacinamide: Level 5Vorinostat, Niacinamide and Etoposide: Level 1Vorinostat, Niacinamide and Etoposide: Level 2
    Arm/Group DescriptionVorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg Vorinostat (SAHA) and Niacinamide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation schemeVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2 Vorinostat, Niacinamide and Etoposide: dose escalation scheme
    All Cause Mortality
    Vorinostat (SAHA) and Niacinamide: Level 1Vorinostat (SAHA) and Niacinamide: Level 2Vorinostat (SAHA) and Niacinamide: Level 3Vorinostat (SAHA) and Niacinamide: Level 4Vorinostat (SAHA) and Niacinamide: Level 5Vorinostat, Niacinamide and Etoposide: Level 1Vorinostat, Niacinamide and Etoposide: Level 2
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Vorinostat (SAHA) and Niacinamide: Level 1Vorinostat (SAHA) and Niacinamide: Level 2Vorinostat (SAHA) and Niacinamide: Level 3Vorinostat (SAHA) and Niacinamide: Level 4Vorinostat (SAHA) and Niacinamide: Level 5Vorinostat, Niacinamide and Etoposide: Level 1Vorinostat, Niacinamide and Etoposide: Level 2
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/5 (40%) 1/3 (33.3%) 0/3 (0%) 5/9 (55.6%) 3/5 (60%) 2/7 (28.6%) 1/6 (16.7%)
    Blood and lymphatic system disorders
    Anemia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Edema0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Cardiac disorders
    Hypotension0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Tachycardia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Gastrointestinal disorders
    Vomiting1/5 (20%) 11/3 (33.3%) 20/3 (0%) 02/9 (22.2%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Diarrhea0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Soreness in mouth0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    General disorders
    Fatigue0/5 (0%) 01/3 (33.3%) 20/3 (0%) 03/9 (33.3%) 41/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Fever0/5 (0%) 01/3 (33.3%) 10/3 (0%) 02/9 (22.2%) 21/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Nausea0/5 (0%) 01/3 (33.3%) 20/3 (0%) 03/9 (33.3%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Death0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Cellulitis0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hypothermia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hepatobiliary disorders
    Liver Failure1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Infections and infestations
    Sepsis0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    MSSA0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Infection0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 02/5 (40%) 31/7 (14.3%) 10/6 (0%) 0
    Zoster0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Investigations
    Hypoglycemia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Metabolism and nutrition disorders
    Acidosis1/5 (20%) 30/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    ALT1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 01/6 (16.7%) 1
    AST1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 01/6 (16.7%) 1
    Creatinine1/5 (20%) 20/3 (0%) 00/3 (0%) 00/9 (0%) 02/5 (40%) 20/7 (0%) 01/6 (16.7%) 1
    Hyperbilirubinemia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hyperkalemia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hypoalbuminemia1/5 (20%) 20/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hyponatremia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    INR1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Thrombocytopenia1/5 (20%) 30/3 (0%) 00/3 (0%) 01/9 (11.1%) 31/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Uric Acid1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Anorexia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Neutropenia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hypokalemia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hypomagnesemia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hypophosphotemia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Urea Nitrogen0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Musculoskeletal and connective tissue disorders
    Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 04/9 (44.4%) 40/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Leg Weakness & Numbness0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Weakness0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Nervous system disorders
    Sensory Neuropathy0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Syncope0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Chord Compression0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Renal and urinary disorders
    Hematuria0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Cough0/5 (0%) 00/3 (0%) 00/3 (0%) 03/9 (33.3%) 51/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Shortness of Breath0/5 (0%) 00/3 (0%) 00/3 (0%) 02/9 (22.2%) 21/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Upper Respiratory Infection0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hypoxia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 02/5 (40%) 21/7 (14.3%) 10/6 (0%) 0
    Low CO20/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Acute Dyspnea0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 20/6 (0%) 0
    Skin and subcutaneous tissue disorders
    Hand-Foot Reaction0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Rash0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Vascular disorders
    DVT0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Other (Not Including Serious) Adverse Events
    Vorinostat (SAHA) and Niacinamide: Level 1Vorinostat (SAHA) and Niacinamide: Level 2Vorinostat (SAHA) and Niacinamide: Level 3Vorinostat (SAHA) and Niacinamide: Level 4Vorinostat (SAHA) and Niacinamide: Level 5Vorinostat, Niacinamide and Etoposide: Level 1Vorinostat, Niacinamide and Etoposide: Level 2
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total5/5 (100%) 3/3 (100%) 3/3 (100%) 9/9 (100%) 5/5 (100%) 7/7 (100%) 6/6 (100%)
    Blood and lymphatic system disorders
    Acidosis1/5 (20%) 30/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 01/6 (16.7%) 1
    Alk Phos1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    ALT2/5 (40%) 31/3 (33.3%) 11/3 (33.3%) 22/9 (22.2%) 41/5 (20%) 11/7 (14.3%) 20/6 (0%) 0
    Ammonia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    ANC1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Anemia0/5 (0%) 01/3 (33.3%) 20/3 (0%) 02/9 (22.2%) 72/5 (40%) 32/7 (28.6%) 90/6 (0%) 0
    AST2/5 (40%) 31/3 (33.3%) 11/3 (33.3%) 12/9 (22.2%) 31/5 (20%) 11/7 (14.3%) 20/6 (0%) 0
    Bilateral Lower Extremity Edema0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Creatinine1/5 (20%) 21/3 (33.3%) 20/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    D-Dimer0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Edema1/5 (20%) 10/3 (0%) 00/3 (0%) 03/9 (33.3%) 51/5 (20%) 12/7 (28.6%) 20/6 (0%) 0
    Elevated Base Excess (intermittent)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Elevated Creatinine0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 12/5 (40%) 71/7 (14.3%) 10/6 (0%) 0
    Elevated Lactate0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 20/6 (0%) 0
    Elevated pH (intermittent)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Elevated PO2 (intermittent)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Elevated WBC0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Groin Swelling (post -op site)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hematuria0/5 (0%) 01/3 (33.3%) 20/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hemoptysis0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hyperbilirubinemia1/5 (20%) 20/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Hypercalcemia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 11/7 (14.3%) 11/6 (16.7%) 1
    Hyperglycemia0/5 (0%) 01/3 (33.3%) 10/3 (0%) 01/9 (11.1%) 10/5 (0%) 01/7 (14.3%) 20/6 (0%) 0
    Hyperkalemia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hypoalbuminemia1/5 (20%) 21/3 (33.3%) 10/3 (0%) 01/9 (11.1%) 10/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Hypoglycemia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hypokalemia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 12/7 (28.6%) 30/6 (0%) 0
    Hypomagnesemia1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hyponatremia1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Hypophosphatemia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 20/7 (0%) 00/6 (0%) 0
    INR1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Left Groin Lymph Node Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Low Chloride (intermittent)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Low CO20/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 11/7 (14.3%) 10/6 (0%) 0
    Low PCO2 (intermittent)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Low PO2 (intermittent)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Metabolic Acidosis0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Neutropenia1/5 (20%) 82/3 (66.7%) 30/3 (0%) 02/9 (22.2%) 31/5 (20%) 11/7 (14.3%) 10/6 (0%) 0
    Nosebleed0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 30/7 (0%) 00/6 (0%) 0
    O2 saturation0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Proteinuria0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Scrotal and Penile Edema0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Swollen Glands0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Thrombocytopenia3/5 (60%) 62/3 (66.7%) 31/3 (33.3%) 22/9 (22.2%) 41/5 (20%) 11/7 (14.3%) 40/6 (0%) 0
    Trace Edema0/5 (0%) 01/3 (33.3%) 10/3 (0%) 03/9 (33.3%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Urea Nitrogen0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 21/7 (14.3%) 10/6 (0%) 0
    Uric Acid1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Cardiac disorders
    CHF Exacerbation0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Heart Palpitations0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Hypotension0/5 (0%) 01/3 (33.3%) 10/3 (0%) 02/9 (22.2%) 21/5 (20%) 20/7 (0%) 00/6 (0%) 0
    MAPS (in 50's)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Mild Hypovalemia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Palpitations0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Sinus Tachycardia0/5 (0%) 01/3 (33.3%) 10/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Tachycardia0/5 (0%) 00/3 (0%) 00/3 (0%) 02/9 (22.2%) 31/5 (20%) 12/7 (28.6%) 30/6 (0%) 0
    Ear and labyrinth disorders
    Ear Ache0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Eye disorders
    Bloodshot eyes0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Dry Eyes0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Left Eye Redness0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Ptosis of the right eye0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Right Eye Redness0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Gastrointestinal disorders
    Abdominal Bloating0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 30/7 (0%) 00/6 (0%) 0
    Abdominal Cramping0/5 (0%) 00/3 (0%) 01/3 (33.3%) 13/9 (33.3%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Abdominal Discomfort1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Acid Reflux0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Anorexia0/5 (0%) 02/3 (66.7%) 42/3 (66.7%) 37/9 (77.8%) 142/5 (40%) 23/7 (42.9%) 53/6 (50%) 4
    Bad Taste in Mouth0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Belching0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Blood in Stool0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Bumps on Tongue1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Burning sensation in throat0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Constipation1/5 (20%) 22/3 (66.7%) 43/3 (100%) 44/9 (44.4%) 72/5 (40%) 31/7 (14.3%) 11/6 (16.7%) 1
    Decrease in taste0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Dehydration0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Diarrhea2/5 (40%) 32/3 (66.7%) 22/3 (66.7%) 77/9 (77.8%) 123/5 (60%) 61/7 (14.3%) 31/6 (16.7%) 3
    Dry Heaving0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Dry Mouth0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Epigastric Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Gagging0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Gas1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 21/7 (14.3%) 20/6 (0%) 0
    GERD0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Gums/Teeth tender feeling0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hiccups0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hoarse Voice0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Hyperactivity of the Gut0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Leakage from rectum0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Metallic Taste0/5 (0%) 00/3 (0%) 00/3 (0%) 03/9 (33.3%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Mouth Sore0/5 (0%) 00/3 (0%) 01/3 (33.3%) 12/9 (22.2%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Mucositis0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 01/6 (16.7%) 1
    Nausea2/5 (40%) 33/3 (100%) 123/3 (100%) 58/9 (88.9%) 285/5 (100%) 215/7 (71.4%) 103/6 (50%) 5
    Petechiae Hard Palate0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Side Mouth Sore0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Soreness in mouth0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Soreness of gumlike0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Stomach Cramps1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Stomach Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Stomach Virus0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Taste Changes0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 01/6 (16.7%) 1
    Tenderness in Mouth, Esophagus, Stomach0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Ulcerations in mouth0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Upset Stomach0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Vomitiing1/5 (20%) 12/3 (66.7%) 102/3 (66.7%) 36/9 (66.7%) 244/5 (80%) 72/7 (28.6%) 31/6 (16.7%) 1
    General disorders
    Death NOS0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hyperactive0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Swollen Cheeks0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Swollen Hands & Feets0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hepatobiliary disorders
    Liver Dysfunction0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Liver Failure1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Infections and infestations
    Aspergillus fumigatus0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Bacterial SuperInfections and infestations0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Cellulitis (lesion on knee)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Disseminated Zoster0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Infections and infestations (Bacterium gram neg rods)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Neutropenic Spesis0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Port Infections and infestations (staphylococcus species, coagulase negative)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Staphyloccus aureus (MSSA)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Transient Viral Infections and infestations0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    URI0/5 (0%) 00/3 (0%) 02/3 (66.7%) 20/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Yeast Infections and infestations0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Zoster0/5 (0%) 00/3 (0%) 03/3 (100%) 33/9 (33.3%) 50/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Metabolism and nutrition disorders
    Chills0/5 (0%) 00/3 (0%) 01/3 (33.3%) 13/9 (33.3%) 42/5 (40%) 21/7 (14.3%) 10/6 (0%) 0
    Fatigue1/5 (20%) 12/3 (66.7%) 73/3 (100%) 99/9 (100%) 175/5 (100%) 174/7 (57.1%) 92/6 (33.3%) 2
    Fever1/5 (20%) 32/3 (66.7%) 52/3 (66.7%) 44/9 (44.4%) 64/5 (80%) 42/7 (28.6%) 21/6 (16.7%) 1
    General Malaise0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hypothermia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Insomnia0/5 (0%) 00/3 (0%) 00/3 (0%) 02/9 (22.2%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Legs Cramps1/5 (20%) 10/3 (0%) 00/3 (0%) 02/9 (22.2%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Night Sweats0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 22/5 (40%) 31/7 (14.3%) 10/6 (0%) 0
    Occasional sweating at night0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Foot Cramp1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Rigors3/5 (60%) 31/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Sore Lymph Nodes(w/ pain)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Sweating0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Weight loss0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Musculoskeletal and connective tissue disorders
    2 episodes of feeling weak & unbalanced0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Abdominal pain0/5 (0%) 01/3 (33.3%) 21/3 (33.3%) 11/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Ache0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 02/9 (22.2%) 22/5 (40%) 20/7 (0%) 00/6 (0%) 0
    Body Aches0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Calf Cramping0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Central Disc Herniation0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Chest Pain0/5 (0%) 00/3 (0%) 01/3 (33.3%) 32/9 (22.2%) 22/5 (40%) 21/7 (14.3%) 10/6 (0%) 0
    Cramping (intermittent)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Decrease in Strength0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Discomfort in Stomach (pain)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Hand Cramping0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Headaches2/5 (40%) 20/3 (0%) 02/3 (66.7%) 25/9 (55.6%) 112/5 (40%) 91/7 (14.3%) 20/6 (0%) 0
    Joint Aches0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Left Hip Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 20/7 (0%) 00/6 (0%) 0
    Left lower quadrant abdominal pain0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Left Sided Abdominal Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Left Upper Quandrant Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Leg Weakness/numbness0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Lower Neck Tighness0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Mild Increasein Intention Tremor0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Mild Neck Soreness0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Mild Right Knee Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Mouth Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Muscle Cramps0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 01/5 (20%) 20/7 (0%) 00/6 (0%) 0
    Muscle Spasms0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Muscular Pain(Buttocks to toes)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Neck Aches (site of enlarged LN)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Ocassional Cramping0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Pleuritic Chest Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Pulled Back Muscle1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Rib Fracture1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Hip Joint Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Groin Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Hip Pain0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Leg Hip Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Lower Back Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Lower Leg Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right rib Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Shoulder Muscle Pain0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Upper Quadrant Pain1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Sinus Headache0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Sore Foot(stepped on nail)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Stiff Fingers1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Suprapubic pain0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    T6/7 & T9/10 Cord Compression0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Toe Cramping0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Upper/Mild Back Spams0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Weakness0/5 (0%) 00/3 (0%) 00/3 (0%) 02/9 (22.2%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Wide based gait when walking0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    T-Cell Lymphoproliferative Disorder1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Nervous system disorders
    Headache2/5 (40%) 21/3 (33.3%) 10/3 (0%) 05/9 (55.6%) 112/5 (40%) 81/7 (14.3%) 20/6 (0%) 0
    Agitated/Irritable Mood0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Anesthesia of Forehead0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Anxiety1/5 (20%) 11/3 (33.3%) 21/3 (33.3%) 13/9 (33.3%) 31/5 (20%) 12/7 (28.6%) 21/6 (16.7%) 1
    Cramping in Hands & Feet0/5 (0%) 00/3 (0%) 01/3 (33.3%) 20/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Depression0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 02/5 (40%) 41/7 (14.3%) 11/6 (16.7%) 1
    Dizziness1/5 (20%) 11/3 (33.3%) 10/3 (0%) 02/9 (22.2%) 20/5 (0%) 00/7 (0%) 02/6 (33.3%) 2
    Facial Tingling0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Finger Parasthesias0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Lack of Concentration0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Light Headedness0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 11/7 (14.3%) 20/6 (0%) 0
    Mild Increase in Tremor (in off week)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Neuropathy0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Occational lightheadedness0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Parasthesia0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Presyncopal Episode0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Sensory Neuropathy in feet0/5 (0%) 00/3 (0%) 00/3 (0%) 02/9 (22.2%) 30/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Short-term memory loss0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Syncope0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Toe Parasthesias0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Renal and urinary disorders
    Burning with Urination0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Clots in Urine0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Difficulty initiating urinary stream0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Dysuria1/5 (20%) 11/3 (33.3%) 10/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Incontinence0/5 (0%) 01/3 (33.3%) 20/3 (0%) 01/9 (11.1%) 12/5 (40%) 20/7 (0%) 00/6 (0%) 0
    Odor with Urination0/5 (0%) 00/3 (0%) 00/3 (0%) 05/9 (55.6%) 51/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Polyuria0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Strong Odor of Urine0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Urgency with urination0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    UTI1/5 (20%) 11/3 (33.3%) 10/3 (0%) 01/9 (11.1%) 11/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Weak urine stream0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Reproductive system and breast disorders
    Cramping (menopausal symptoms)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Decrease Sex Drive0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Hot flashes0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 20/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Vaginal dryness (menopausal symptoms)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Acute Dyspnea0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Chest Congestion2/5 (40%) 20/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Chest Pressure0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Chest tightness0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Clear Rhinorrhea0/5 (0%) 00/3 (0%) 01/3 (33.3%) 20/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Cold0/5 (0%) 00/3 (0%) 01/3 (33.3%) 23/9 (33.3%) 31/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Collapsed Lung0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 01/7 (14.3%) 10/6 (0%) 0
    Congestion1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Cough2/5 (40%) 31/3 (33.3%) 22/3 (66.7%) 54/9 (44.4%) 104/5 (80%) 92/7 (28.6%) 20/6 (0%) 0
    Dysphagia0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Dyspnea (DOE)0/5 (0%) 00/3 (0%) 02/3 (66.7%) 34/9 (44.4%) 62/5 (40%) 40/7 (0%) 01/6 (16.7%) 1
    Epistaxis (mild & intermittent)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hypoxia0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 02/5 (40%) 21/7 (14.3%) 10/6 (0%) 0
    Mild Dyspena0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Mild Sore Throat0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Nasal Congestion0/5 (0%) 00/3 (0%) 02/3 (66.7%) 33/9 (33.3%) 40/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Pneumonia (Probable)1/5 (20%) 10/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Post Nasal Drip0/5 (0%) 00/3 (0%) 01/3 (33.3%) 20/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Productive Cough1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Rhinorrhea1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Runny Nose0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Shortness of Breath0/5 (0%) 00/3 (0%) 02/3 (66.7%) 23/9 (33.3%) 41/5 (20%) 31/7 (14.3%) 10/6 (0%) 0
    Slight cough0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Slight dry cough0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Slight hoarseness0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Sore Throat1/5 (20%) 10/3 (0%) 02/3 (66.7%) 52/9 (22.2%) 41/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Throat Tightening0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Upper Respitatory Infections and infestations0/5 (0%) 00/3 (0%) 00/3 (0%) 03/9 (33.3%) 41/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Skin and subcutaneous tissue disorders
    3 Puncatate skin Leasions on Arm(mosquito bites)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Acne (following RT)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Alopecia0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Armpit Burning1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Burning near rectum (likely zoster related)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Dermatitis0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Diffuse Erythematous Rash ( extremeties)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Diffuse PapilarRash ( hypersensitivity reaction)0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Dry Lips1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Dry Skin0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 20/5 (0%) 00/7 (0%) 01/6 (16.7%) 1
    Erythematous (slightly on neck)0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Eschai of ight index finger0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Flushing0/5 (0%) 00/3 (0%) 00/3 (0%) 04/9 (44.4%) 62/5 (40%) 53/7 (42.9%) 30/6 (0%) 0
    Hand- Foot Reaction0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Hives0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    itching1/5 (20%) 20/3 (0%) 01/3 (33.3%) 12/9 (22.2%) 21/5 (20%) 11/7 (14.3%) 10/6 (0%) 0
    Left Breast Itchy Rash0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Left Nipple Bump1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Papular Rash0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 11/7 (14.3%) 10/6 (0%) 0
    Pruritic Rash0/5 (0%) 00/3 (0%) 00/3 (0%) 02/9 (22.2%) 32/5 (40%) 40/7 (0%) 01/6 (16.7%) 1
    Rash (mid area of chest)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Rash(below left breast)1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Rash(blotchy dry spots on hands)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Redness & slight bump on right of nose0/5 (0%) 01/3 (33.3%) 10/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Arm Swelling(bug bite)1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Cheek Red Macule0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Right Hand Inflammation(cat scratch)1/5 (20%) 10/3 (0%) 00/3 (0%) 00/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Skin Lesion lower back0/5 (0%) 00/3 (0%) 01/3 (33.3%) 10/9 (0%) 00/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Skin tenderness on face0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0
    Slight Flushing0/5 (0%) 00/3 (0%) 00/3 (0%) 00/9 (0%) 01/5 (20%) 10/7 (0%) 00/6 (0%) 0
    Vascular disorders
    DVT ( Left subclavala vein)0/5 (0%) 00/3 (0%) 00/3 (0%) 01/9 (11.1%) 10/5 (0%) 00/7 (0%) 00/6 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleOwen A. O'Connor, MD, Ph.D.
    OrganizationColumbia University Medical Center
    Phone212-326-5720
    Emailoo2130@cumc.columbia.edu
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT00691210
    Other Study ID Numbers:
    • AAAJ3001
    First Posted:
    Jun 5, 2008
    Last Update Posted:
    Nov 20, 2020
    Last Verified:
    Nov 1, 2020