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Clinical Study of Ixabepilone Administered as a 24 Hour Infusion in Patients With Solid Malignancies.

Sponsor
R-Pharm (Industry)
Overall Status
Completed
CT.gov ID
NCT00162136
Collaborator
(none)
35
Enrollment
3
Locations
1
Arm
34
Duration (Months)
11.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the dose limiting toxicities, minimum tolerated dose and recommended dose for Phase II studies.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study of Ixabepilone Administered as a 24-Hour Infusion in Patients With Advanced Solid Malignancies
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A1

Drug: Ixabepilone
Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
Other Names:
  • IXEMPRA®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Dose Limiting Toxicities at Dose Level [Measures taken at Cycle 01 (21-day cycle)]

      Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.

    Secondary Outcome Measures

    1. Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation [From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.]

      Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).

    2. Hematology Results - Worst On-Study Grade [Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.]

      Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).

    3. Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level [through 72 hours after start of infusion]

      Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)

    4. Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST) [At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.]

      RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • confirmed diagnosis of a primary solid tumor

    • measurable or non-measurable disease

    • progressive disease

    • men and women greater or equal to 18 years of age.

    Exclusion Criteria:

    • women of child bearing potential who are not using birth control

    • women who are pregnant or breast feeding

    • women with a positive pregnancy test on enrollment

    • patients with brain metastasis

    • prior treatment with Ixabepilone

    • known history of human immunodeficiency virus (HIV)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Of Maryland Baltimore Maryland United States 21201
    2 The Cancer Institute Of New Jersey New Brunswick New Jersey United States 08901
    3 Cleveland Clinic Foundation Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • R-Pharm

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00162136
    Other Study ID Numbers:
    • CA163-085
    First Posted:
    Sep 13, 2005
    Last Update Posted:
    Nov 2, 2020
    Last Verified:
    Feb 1, 2016
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 39 participants enrolled and 4 participants were never treated (2 reported serious adverse events [SAEs] prior to the first dose of study medication and were never treated; 1 had rapid decline in performance status and died prior to the first dose of study medication; no reason was given for the remaining participant).
    Arm/Group Title Ixabepilone
    Arm/Group Description Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
    Period Title: Overall Study
    STARTED 35
    COMPLETED 0
    NOT COMPLETED 35

    Baseline Characteristics

    Arm/Group Title 10 mg/m2 20 mg/m2 30 mg/m2 35 mg/m2 40 mg/m2 45 mg/m2 Total
    Arm/Group Description Ixabepilone Ixabepilone Ixabepilone Ixabepilone Ixabepilone Ixabepilone Total of all reporting groups
    Overall Participants 4 3 8 4 11 5 35
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    63.5
    59.0
    61.5
    59.5
    58.0
    52.0
    59.0
    Sex: Female, Male (Count of Participants)
    Female
    1
    25%
    0
    0%
    5
    62.5%
    2
    50%
    5
    45.5%
    3
    60%
    16
    45.7%
    Male
    3
    75%
    3
    100%
    3
    37.5%
    2
    50%
    6
    54.5%
    2
    40%
    19
    54.3%
    Race/Ethnicity, Customized (participants) [Number]
    White
    3
    75%
    2
    66.7%
    7
    87.5%
    3
    75%
    9
    81.8%
    2
    40%
    26
    74.3%
    Black
    0
    0%
    1
    33.3%
    0
    0%
    1
    25%
    1
    9.1%
    2
    40%
    5
    14.3%
    Asian
    1
    25%
    0
    0%
    1
    12.5%
    0
    0%
    1
    9.1%
    1
    20%
    4
    11.4%
    Karnofsky Performance Status (participants) [Number]
    90 to 100
    2
    50%
    2
    66.7%
    6
    75%
    2
    50%
    7
    63.6%
    3
    60%
    22
    62.9%
    70 to 80
    2
    50%
    1
    33.3%
    2
    25%
    2
    50%
    4
    36.4%
    2
    40%
    13
    37.1%
    0 to 60
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Dose Limiting Toxicities at Dose Level
    Description Dose limiting toxicities=any of the following events attributed to Ixabepilone occuring during the first cycle: grade 3/4 nausea, vomiting, or diarrhea despite medical intervention and/or prophylaxis; other Grade ≥3 nonhematological toxicity; any toxicity requiring study therapy discontinuation; delayed recovery from study therapy-related toxicity which delays scheduled re-treatment for >14 days; Grade 4 neutropenia for ≥5 consecutive days; grade 3/4 neutropenia with sepsis or a fever ≥38.5 C; thrombocytopenia <25,000 cells/mm3 or bleeding requiring a platelet transfusion.
    Time Frame Measures taken at Cycle 01 (21-day cycle)

    Outcome Measure Data

    Analysis Population Description
    All treated participants
    Arm/Group Title 10 mg/m2 20 mg/m2 30 mg/m2 35 mg/m2 40 mg/m2 45 mg/m2
    Arm/Group Description Ixabepilone Ixabepilone Ixabepilone Ixabepilone Ixabepilone Ixabepilone
    Measure Participants 4 3 8 4 11 5
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    9.1%
    2
    40%
    2. Secondary Outcome
    Title Treatment Related Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation
    Description Adverse events (AEs) and Serious AEs (SAEs) considered possibly, probably, or certainly related to study treatment, graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).
    Time Frame From time of screening through post study follow-up at a maximum of 21 9-day cycles. Toxicity assessments occured at least every 4 weeks until all study drug related toxicities.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Grade 1/2 Grade 3/4 All Grades
    Arm/Group Description Grade 1=Mild, Grade 2=Moderate Grade 3=Severe, Grade 4=Life-threatening or disabling Grades 1-4
    Measure Participants 35 35 35
    Any Treatment-Related AE
    12
    300%
    21
    700%
    33
    412.5%
    Nausea
    16
    400%
    0
    0%
    16
    200%
    Fatigue
    14
    350%
    2
    66.7%
    16
    200%
    Alopecia
    12
    300%
    0
    0%
    12
    150%
    Diarrhea
    11
    275%
    0
    0%
    11
    137.5%
    Peripheral sensory neuropathy
    9
    225%
    0
    0%
    9
    112.5%
    Stomatitis
    9
    225%
    0
    0%
    9
    112.5%
    Any SAE
    0
    0%
    16
    533.3%
    16
    200%
    Death within 30 days of last dose
    0
    0%
    1
    33.3%
    1
    12.5%
    Any AE leading to discontinuation
    0
    0%
    5
    166.7%
    5
    62.5%
    3. Secondary Outcome
    Title Hematology Results - Worst On-Study Grade
    Description Worst on-study grade based on laboratory values graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death).
    Time Frame Baseline (within 2 weeks of dosing), weekly, and within 72 hours prior to each subsequent 21-day cycle. If CTC Grade 4 hematologic toxicity is observed, complete blood count plus differential and platelets repeated every 3 days until resolution.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Grade 0 Grade 1 Grade 2 Grade 3 Grade 4
    Arm/Group Description Absent Mild Moderate Severe Life-threatening or disabling
    Measure Participants 35 35 35 35 35
    White Blood Cells
    5
    125%
    5
    166.7%
    8
    100%
    10
    250%
    7
    63.6%
    Absolute Neutrophil Count
    8
    200%
    5
    166.7%
    6
    75%
    5
    125%
    11
    100%
    Hemoglobin
    1
    25%
    14
    466.7%
    13
    162.5%
    7
    175%
    0
    0%
    Platelets
    21
    525%
    9
    300%
    0
    0%
    3
    75%
    2
    18.2%
    4. Secondary Outcome
    Title Mean Plasma Concentration of Ixabepilone at 40 mg/m2 Dose Level
    Description Mean concentrations over full time period for the 40 mg/mg2 dose level, established as the Maximum Tolerated Dose. (The Maximum Tolerated Dose was established as 40 mg/m2, based on an investiagtion of Dose Limiting Toxicities, which consisted of Febrile Neutropenia (at 40 mg/m2) in 1 participant and Grade 4 neutropenia lasting ≥5 days (at 45 mg/m2)in 2 participants.)
    Time Frame through 72 hours after start of infusion

    Outcome Measure Data

    Analysis Population Description
    All participants treated at the 40 mg/m2 dose level.
    Arm/Group Title Treated Subjects
    Arm/Group Description All treated subjects with measurement at timepoint
    Measure Participants 11
    Hour 0.00 (n=11)
    0
    (0)
    Hour 1.00 (n=11)
    20.79
    (14.12)
    Hour 2.00 (n=11)
    24.31
    (13.64)
    Hour 4.00 (n=11)
    33.15
    (32.75)
    Hour 8.00 (n=11)
    32.04
    (16.20)
    Hour 12.00 (n=11)
    35.25
    (11.96)
    Hour 16.00 (n=11)
    44.47
    (13.80)
    Hour 20.00 (n=11)
    55.05
    (29.41)
    Hour 24.00 (n=11)
    54.71
    (23.63)
    Hour 25.00 (n=10)
    35.59
    (24.51)
    Hour 26.00 (n=10)
    33.70
    (17.17)
    Hour 27.00 (n=10)
    35.15
    (20.47)
    Hour 72.00 (n=10)
    27.45
    (47.71)
    5. Secondary Outcome
    Title Best Tumor Response, According to Response Evaluation Criteria in Solid Tumors (RECIST)
    Description RECIST criteria, wherein complete response = disappearance of all target lesions; partial response = 30% decrease in the sum of the longest diameter of target lesions; progressive disease = 20% increase in the sum of the longest diameter of target lesions, and stable disease = small changes that do not meet above criteria.
    Time Frame At Baseline (up to 2 weeks prior to starting therapy), after every 2nd cycle, and at post study follow-upn after a maximum of 9 cycles.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title All Treated Participants
    Arm/Group Description
    Measure Participants 35
    Complete Response
    0
    0%
    Partial Response
    0
    0%
    Stable Disease
    14
    350%
    Progressive Disease
    15
    375%
    Unable to Determine
    6
    150%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Ixa 10 mg/m2 Ixa 20 mg/m2 Ixa 30 mg/m2 Ixa 35 mg/m2 Ixa 40 mg/m2 Ixa 45 mg/m2
    Arm/Group Description
    All Cause Mortality
    Ixa 10 mg/m2 Ixa 20 mg/m2 Ixa 30 mg/m2 Ixa 35 mg/m2 Ixa 40 mg/m2 Ixa 45 mg/m2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Ixa 10 mg/m2 Ixa 20 mg/m2 Ixa 30 mg/m2 Ixa 35 mg/m2 Ixa 40 mg/m2 Ixa 45 mg/m2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/4 (50%) 2/3 (66.7%) 4/8 (50%) 1/4 (25%) 5/11 (45.5%) 2/5 (40%)
    Blood and lymphatic system disorders
    LEUKOPENIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    NEUTROPENIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    THROMBOCYTOPENIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    FEBRILE NEUTROPENIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Congenital, familial and genetic disorders
    TRACHEO-OESOPHAGEAL FISTULA 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Gastrointestinal disorders
    ILEUS 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    NAUSEA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    VOMITING 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    DIARRHOEA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    General disorders
    FATIGUE 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    CHEST PAIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    Hepatobiliary disorders
    CHOLECYSTITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    HEPATORENAL SYNDROME 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Infections and infestations
    INFECTION 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    PNEUMONIA 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    UROSEPSIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    CELLULITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    SEPTIC SHOCK 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Investigations
    NEUTROPHIL COUNT DECREASED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    Metabolism and nutrition disorders
    DEHYDRATION 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    GLUCOSE TOLERANCE IMPAIRED 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Musculoskeletal and connective tissue disorders
    PAIN IN EXTREMITY 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 1/5 (20%)
    MUSCULOSKELETAL PAIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    TUMOUR PAIN 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    MALIGNANT NEOPLASM PROGRESSION 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Nervous system disorders
    SYNCOPE 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    HEADACHE 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    DIZZINESS 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    HEMIPARESIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    HYPOAESTHESIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    Renal and urinary disorders
    RENAL FAILURE ACUTE 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    DYSPNOEA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    EPISTAXIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    PULMONARY EMBOLISM 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    RESPIRATORY FAILURE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Vascular disorders
    HYPOTENSION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    DEEP VEIN THROMBOSIS 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Other (Not Including Serious) Adverse Events
    Ixa 10 mg/m2 Ixa 20 mg/m2 Ixa 30 mg/m2 Ixa 35 mg/m2 Ixa 40 mg/m2 Ixa 45 mg/m2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/4 (100%) 3/3 (100%) 8/8 (100%) 4/4 (100%) 11/11 (100%) 5/5 (100%)
    Blood and lymphatic system disorders
    ANAEMIA 2/4 (50%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 5/11 (45.5%) 2/5 (40%)
    LEUKOPENIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    NEUTROPENIA 0/4 (0%) 0/3 (0%) 4/8 (50%) 1/4 (25%) 7/11 (63.6%) 3/5 (60%)
    THROMBOCYTOPENIA 1/4 (25%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 4/11 (36.4%) 0/5 (0%)
    FEBRILE NEUTROPENIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    Cardiac disorders
    TACHYCARDIA 1/4 (25%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    PALPITATIONS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Ear and labyrinth disorders
    HYPOACUSIS 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Eye disorders
    DRY EYE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    ECTROPION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    PHOTOPSIA 0/4 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    EYE OEDEMA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    EYE IRRITATION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    VISION BLURRED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    ERYTHEMA OF EYELID 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Gastrointestinal disorders
    NAUSEA 2/4 (50%) 3/3 (100%) 7/8 (87.5%) 2/4 (50%) 6/11 (54.5%) 0/5 (0%)
    LIP DRY 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    RETCHING 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    VOMITING 0/4 (0%) 2/3 (66.7%) 4/8 (50%) 0/4 (0%) 3/11 (27.3%) 0/5 (0%)
    CHEILITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    DIARRHOEA 0/4 (0%) 0/3 (0%) 5/8 (62.5%) 3/4 (75%) 6/11 (54.5%) 0/5 (0%)
    DRY MOUTH 0/4 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/4 (0%) 3/11 (27.3%) 0/5 (0%)
    DYSPEPSIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    DYSPHAGIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    GLOSSITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    ORAL PAIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    TOOTHACHE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    FLATULENCE 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    STOMATITIS 0/4 (0%) 1/3 (33.3%) 3/8 (37.5%) 0/4 (0%) 4/11 (36.4%) 1/5 (20%)
    LOOSE TOOTH 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    ODYNOPHAGIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    CONSTIPATION 1/4 (25%) 2/3 (66.7%) 4/8 (50%) 1/4 (25%) 5/11 (45.5%) 2/5 (40%)
    OESOPHAGITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    ABDOMINAL PAIN 0/4 (0%) 0/3 (0%) 3/8 (37.5%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    MOUTH ULCERATION 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    GINGIVAL ERYTHEMA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HYPOAESTHESIA ORAL 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    RECTAL HAEMORRHAGE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    STOMACH DISCOMFORT 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    ABDOMINAL DISTENSION 2/4 (50%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    ABDOMINAL PAIN LOWER 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    ABDOMINAL PAIN UPPER 0/4 (0%) 0/3 (0%) 2/8 (25%) 1/4 (25%) 2/11 (18.2%) 0/5 (0%)
    TONGUE DISCOLOURATION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    GASTROINTESTINAL DISORDER 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    IMPAIRED GASTRIC EMPTYING 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    GASTROOESOPHAGEAL REFLUX DISEASE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    General disorders
    PAIN 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    CHILLS 2/4 (50%) 2/3 (66.7%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 1/5 (20%)
    THIRST 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    FATIGUE 1/4 (25%) 3/3 (100%) 6/8 (75%) 3/4 (75%) 8/11 (72.7%) 3/5 (60%)
    PYREXIA 0/4 (0%) 0/3 (0%) 2/8 (25%) 2/4 (50%) 2/11 (18.2%) 0/5 (0%)
    ASTHENIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    CHEST PAIN 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    FEELING COLD 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    OEDEMA PERIPHERAL 1/4 (25%) 1/3 (33.3%) 2/8 (25%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    MUCOSAL HAEMORRHAGE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    MUCOSAL INFLAMMATION 0/4 (0%) 0/3 (0%) 2/8 (25%) 0/4 (0%) 2/11 (18.2%) 1/5 (20%)
    NON-CARDIAC CHEST PAIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    CATHETER RELATED COMPLICATION 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    Hepatobiliary disorders
    HYPERBILIRUBINAEMIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 2/5 (40%)
    Infections and infestations
    RHINITIS 0/4 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    INFECTION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    SINUSITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 1/5 (20%)
    CANDIDIASIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    TINEA PEDIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    FOLLICULITIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    TOOTH INFECTION 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    ORAL CANDIDIASIS 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    URINARY TRACT INFECTION 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    UPPER RESPIRATORY TRACT INFECTION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    Injury, poisoning and procedural complications
    CONTUSION 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    ANIMAL BITE 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    PROCEDURAL PAIN 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Investigations
    WEIGHT DECREASED 0/4 (0%) 1/3 (33.3%) 4/8 (50%) 1/4 (25%) 1/11 (9.1%) 1/5 (20%)
    HAEMOGLOBIN DECREASED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 2/5 (40%)
    URINE OUTPUT DECREASED 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    BLOOD ALBUMIN DECREASED 1/4 (25%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    BLOOD CALCIUM DECREASED 1/4 (25%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    BLOOD GLUCOSE INCREASED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    PLATELET COUNT DECREASED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    BLOOD PHOSPHORUS DECREASED 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    NEUTROPHIL COUNT DECREASED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    GASTRIC OCCULT BLOOD POSITIVE 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    WAIST CIRCUMFERENCE INCREASED 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    ELECTROCARDIOGRAM QT PROLONGED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    WHITE BLOOD CELL COUNT DECREASED 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 1/5 (20%)
    ASPARTATE AMINOTRANSFERASE INCREASED 1/4 (25%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    BLOOD ALKALINE PHOSPHATASE INCREASED 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Metabolism and nutrition disorders
    ANOREXIA 0/4 (0%) 1/3 (33.3%) 4/8 (50%) 2/4 (50%) 2/11 (18.2%) 1/5 (20%)
    DEHYDRATION 1/4 (25%) 0/3 (0%) 2/8 (25%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HYPOKALAEMIA 0/4 (0%) 0/3 (0%) 3/8 (37.5%) 0/4 (0%) 2/11 (18.2%) 1/5 (20%)
    HYPERKALAEMIA 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    HYPOCALCAEMIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    HYPONATRAEMIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    HYPERGLYCAEMIA 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    HYPOMAGNESAEMIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 2/11 (18.2%) 0/5 (0%)
    HYPOALBUMINAEMIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 2/5 (40%)
    DECREASED APPETITE 0/4 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Musculoskeletal and connective tissue disorders
    MYALGIA 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 4/11 (36.4%) 1/5 (20%)
    BACK PAIN 1/4 (25%) 1/3 (33.3%) 1/8 (12.5%) 0/4 (0%) 4/11 (36.4%) 0/5 (0%)
    BONE PAIN 1/4 (25%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    NECK PAIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    ARTHRALGIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 3/11 (27.3%) 1/5 (20%)
    FLANK PAIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    PAIN IN JAW 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    MUSCLE SPASMS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 1/5 (20%)
    JOINT SWELLING 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    JOINT STIFFNESS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    MUSCULAR WEAKNESS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    PAIN IN EXTREMITY 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 3/11 (27.3%) 0/5 (0%)
    MOBILITY DECREASED 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    SENSATION OF HEAVINESS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    Nervous system disorders
    TREMOR 0/4 (0%) 2/3 (66.7%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    APHASIA 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HEADACHE 1/4 (25%) 1/3 (33.3%) 3/8 (37.5%) 1/4 (25%) 0/11 (0%) 2/5 (40%)
    DIZZINESS 0/4 (0%) 2/3 (66.7%) 1/8 (12.5%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    DYSGEUSIA 0/4 (0%) 2/3 (66.7%) 3/8 (37.5%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    PARAESTHESIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    HYPOAESTHESIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HYPERAESTHESIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    MENTAL IMPAIRMENT 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    SYNCOPE VASOVAGAL 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    RESTLESS LEGS SYNDROME 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    PERIPHERAL MOTOR NEUROPATHY 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    PERIPHERAL SENSORY NEUROPATHY 0/4 (0%) 1/3 (33.3%) 3/8 (37.5%) 1/4 (25%) 5/11 (45.5%) 1/5 (20%)
    Psychiatric disorders
    ANXIETY 0/4 (0%) 1/3 (33.3%) 2/8 (25%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    INSOMNIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    AGITATION 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    NIGHTMARE 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    DEPRESSION 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 1/5 (20%)
    ABNORMAL DREAMS 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    CONFUSIONAL STATE 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    MENTAL STATUS CHANGES 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    Renal and urinary disorders
    NOCTURIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    POLLAKIURIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 1/5 (20%)
    RENAL FAILURE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    ACUTE PRERENAL FAILURE 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    STRESS URINARY INCONTINENCE 1/4 (25%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Reproductive system and breast disorders
    VULVOVAGINAL PRURITUS 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 4/4 (100%) 2/11 (18.2%) 2/5 (40%)
    HYPOXIA 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 1/5 (20%)
    DYSPNOEA 2/4 (50%) 0/3 (0%) 2/8 (25%) 1/4 (25%) 2/11 (18.2%) 1/5 (20%)
    SNEEZING 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    DYSPHONIA 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    EPISTAXIS 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HAEMOPTYSIS 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    NASAL CONGESTION 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    PLEURAL EFFUSION 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 1/5 (20%)
    DYSPNOEA EXERTIONAL 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    PHARYNGOLARYNGEAL PAIN 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 1/4 (25%) 1/11 (9.1%) 0/5 (0%)
    Skin and subcutaneous tissue disorders
    ALOPECIA 0/4 (0%) 0/3 (0%) 6/8 (75%) 1/4 (25%) 5/11 (45.5%) 1/5 (20%)
    DRY SKIN 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    PRURITUS 0/4 (0%) 1/3 (33.3%) 1/8 (12.5%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    URTICARIA 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    ONYCHOLYSIS 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    NIGHT SWEATS 1/4 (25%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    RASH PAPULAR 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HYPERHIDROSIS 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    NAIL DISORDER 0/4 (0%) 0/3 (0%) 0/8 (0%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    SKIN DISORDER 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    SKIN EXFOLIATION 0/4 (0%) 0/3 (0%) 0/8 (0%) 1/4 (25%) 0/11 (0%) 0/5 (0%)
    SUBCUTANEOUS NODULE 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)
    Vascular disorders
    FLUSHING 0/4 (0%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 1/11 (9.1%) 0/5 (0%)
    HYPOTENSION 0/4 (0%) 1/3 (33.3%) 0/8 (0%) 0/4 (0%) 2/11 (18.2%) 0/5 (0%)
    HYPERTENSION 1/4 (25%) 0/3 (0%) 1/8 (12.5%) 0/4 (0%) 0/11 (0%) 0/5 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/Title Bristol-Myers Squibb Study Director
    Organization Bristol-Myers Squibb
    Phone
    Email Clinical.Trials@bms.com
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00162136
    Other Study ID Numbers:
    • CA163-085
    First Posted:
    Sep 13, 2005
    Last Update Posted:
    Nov 2, 2020
    Last Verified:
    Feb 1, 2016