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    Clinical Trial Results:
    A Phase III Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women with Advanced Endometrial Cancer Who Have Previously Been Treated with Chemotherapy.

    Summary
    EudraCT number
    		 2008-007167-16
    Trial protocol
    		 GB   BE   IT   ES   FR   SE   GR   DK   HU   FI   CZ  
    Global end of trial date
    08 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Aug 2016
    First version publication date
    18 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA163-196
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00883116
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Aug 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 11
    Country: Number of subjects enrolled
    Spain: 35
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Belgium: 22
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Denmark: 16
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Greece: 16
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    Italy: 47
    Country: Number of subjects enrolled
    Argentina: 9
    Country: Number of subjects enrolled
    Australia: 6
    Country: Number of subjects enrolled
    Brazil: 25
    Country: Number of subjects enrolled
    Canada: 56
    Country: Number of subjects enrolled
    Mexico: 21
    Country: Number of subjects enrolled
    Peru: 23
    Country: Number of subjects enrolled
    Russian Federation: 51
    Country: Number of subjects enrolled
    United States: 154
    Worldwide total number of subjects
    551
    EEA total number of subjects
    206
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    296
    From 65 to 84 years
    252
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 496 subjects were randomised in the study and 487 subjects were treated (248 subjects in the ixabepilone arm and 239 subjects in the control arm).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open label, hence blinding was not applicable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ixabepilone, 40 mg/m^2, IV
    Arm description
    		 Subjects received ixabepilone, 40 mg/m^2, intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixabepilone
    Investigational medicinal product code
    BMS-247550
    Other name
    Ixempra
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ixabepilone 40 mg/m^2 IV infusion over 3 hours, every 21 days until unacceptable toxicity or disease progression.

    Arm title
    		 Control chemotherapy
    Arm description
    		 Subjects received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Adriacin, Adriamycin PFS/RDF, Adriblastina, Adriablastine, Adrimedac, Doxorubin, Farmiblasti, Rubexna, DOXO-CELL, Doxolem
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Doxorubicin 60 mg/m^2 IV infusion either in a peripheral or central venous line, every 21 days until unacceptable toxicity or disease progression.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Taxol, Anzatax, Asotax, Bristaxol Praxel, Taxol Konzentrat, F1-106
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 175 mg/m^2 IV infusion over 3 hours, every 21 days until unacceptable toxicity or disease progression.

    Number of subjects in period 1 [1]
    		Ixabepilone, 40 mg/m^2, IV Control chemotherapy
    Started
    248
    248
    Completed
    39
    29
    Not completed
    209
    219
         No longer meet study criteria
    2
    1
         Consent withdrawn by subject
    1
    2
         Disease progression
    130
    127
         Study drug toxicity
    36
    16
         Death
    6
    2
         Subject request to discontinue study treatment
    13
    5
         Maximum clinical benefit
    13
    46
         Adverse event unrelated to study drug
    5
    10
         Never treated
    -
    9
         Lost to follow-up
    -
    1
         unspecified
    3
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 551 subjects that were enrolled, 496 subjects were randomised in the study and 487 subjects were treated (248 subjects in the ixabepilone arm and 239 subjects in the control arm).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ixabepilone, 40 mg/m^2, IV
    Reporting group description
    		 Subjects received ixabepilone, 40 mg/m^2, intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression.

    Reporting group title
    Control chemotherapy
    Reporting group description
    		 Subjects received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

    Reporting group values
    		 Ixabepilone, 40 mg/m^2, IV Control chemotherapy Total
    Number of subjects
    		 248 248 496
    Age categorical
    Units: Subjects
        <65 years
    		 126 139 265
        >=65 years
    		 122 109 231
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (39 to 86) 64 (33 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 248 248 496
        Male
    		 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 215 213 428
        Black or African American
    		 12 18 30
        Asian
    		 6 5 11
        Other
    		 12 12 24
        American Indian or Alaska Native
    		 3 0 3
    Karnofsky Performance Scale Index Status
    This scale classifies subjects by functional impairment. The lower the Karnofsky score, the more impaired the subject is. 100=No complaints; 90=Normal activity; 80=Normal activity with effort; 70=Cares for self but unable to carry on normal activity or to do active work; 60=Requires occasional assistance, but is able to care for most personal needs; 50=Requires considerable assistance; 40=Disabled; requires special care; 30=Severely disabled hospitalization indicated; 20=Very sick; hospital admission necessary; 10=Fatal processes progressing rapidly; 0=Death.
    Units: Subjects
        100
    		 86 86 172
        90
    		 95 79 174
        80
    		 48 64 112
        70
    		 19 16 35
        Fewer than 70
    		 0 2 2
        Not reported
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Ixabepilone, 40 mg/m^2, IV
    Reporting group description
    		 Subjects received ixabepilone, 40 mg/m^2, intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression.

    Reporting group title
    Control chemotherapy
    Reporting group description
    		 Subjects received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Survival was defined as the time from the date of randomisation until the date of death. If the subject did not die, OS was censored on the last date he or she was known to be alive. The analysis was performed on all the randomised subjects.
    End point type
    Primary
    End point timeframe
    Date of randomization to date of death or last date censored to up to approximately 26 months
    End point values
    		 Ixabepilone, 40 mg/m^2, IV Control chemotherapy
    Number of subjects analysed
    248
    248
    Units: Month
        median (confidence interval 95%)
    10.9 (8.5 to 12.7)
    12.3 (10.7 to 15.4)
    Statistical analysis title
    		 Overall survival comparison
    Comparison groups
    Control chemotherapy v Ixabepilone, 40 mg/m^2, IV
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0397
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.74

    Secondary: Progression-free Survival

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    End point title
    		 Progression-free Survival
    End point description
    Progression-free survival was defined as the time from randomization to the date of documented disease progression. Subjects who died without a reported prior progression were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last tumor assessment. Subjects who did not have any on-study tumor assessments were censored on the date they were randomized. Measurable disease was present if the subject had 1 or more measurable lesions. The analysis was performed on all the subjects with measurable disease at randomisation.
    End point type
    Secondary
    End point timeframe
    Date of randomization up to disease progression or death (or date of last tumor assessment for those who did not die or progress) up to approximately 22 months
    End point values
    		 Ixabepilone, 40 mg/m^2, IV Control chemotherapy
    Number of subjects analysed
    223
    223
    Units: Months
        median (confidence interval 95%)
    3.4 (2.8 to 4.2)
    4 (2.7 to 4.3)
    Statistical analysis title
    		 Progression-free Survival Comparison
    Comparison groups
    Ixabepilone, 40 mg/m^2, IV v Control chemotherapy
    Number of subjects included in analysis
    446
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8011
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.29

    Secondary: Best Overall Response Rate

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    End point title
    		 Best Overall Response Rate
    End point description
    Best overall response rate was defined as the number of subjects whose best response was either partial response (PR) or complete response (CR) divided by the number of subjects in the treatment group. Overall tumor response was based on an integration of the evaluation of target, non target, and new lesions. CR=Disappearance of all clinical and radiologic evidence of target lesions. PR=At least 30% reduction in the sum of diameters of all target lesions, taking as reference the baseline study measurement. Changes in tumor measurements need not be confirmed by repeat measurements performed after the criteria for response were first met. The analysis was performed on all randomised subjects with measurable disease.
    End point type
    Secondary
    End point timeframe
    Date of randomization and every 6 weeks to end of treatment (9 cycles, or approximately Day 189)
    End point values
    		 Ixabepilone, 40 mg/m^2, IV Control chemotherapy
    Number of subjects analysed
    223
    223
    Units: Percentage of subjects
        number (confidence interval 95%)
    15.2 (10.8 to 20.6)
    15.7 (11.2 to 21.1)
    No statistical analyses for this end point

    Secondary: Number of Subjects With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug

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    End point title
    		 Number of Subjects With a Serious Adverse Event (SAE), an SAE Related to Study Drug, Death as Outcome, a Peripheral Neuropathy Adverse Event (AE), a Grade 3 or Higher AE, and an AE Related to Study Drug
    End point description
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related to study drug=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. The analysis was performed on all subjects who received at least 1 dose of ixabepilone.
    End point type
    Secondary
    End point timeframe
    Baseline up to disease progression or until study related toxicities resolve to baseline
    End point values
    		 Ixabepilone, 40 mg/m^2, IV Control chemotherapy
    Number of subjects analysed
    248
    239
    Units: subjects
        SAEs
    89
    70
        Any SAE related to study drug
    43
    29
        Deaths
    121
    95
        Any AE related to study drug
    223
    215
        Any AE leading to study drug discontinuation
    49
    37
        Any peripheral neuropathy AE
    108
    62
        Any Grade 3 or higher AE
    160
    148
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to disease progression or until study related toxicities resolve to baseline
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Ixabepilone, 40 mg/m^2, IV
    Reporting group description
    		 Subjects received ixabepilone, 40 milligram per square meter (mg/m^2), intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression.

    Reporting group title
    Doxorubicin, 60 mg/m^2, IV
    Reporting group description
    		 Doxorubicin 60 mg/m^2 IV infusion either in a peripheral or central venous line, every 21 days until unacceptable toxicity or disease progression.

    Reporting group title
    Paclitaxel, 175 mg/m^2, IV
    Reporting group description
    		 Paclitaxel 175 mg/m^2 IV infusion over 3 hours, every 21 days until unacceptable toxicity or disease progression.

    Serious adverse events
    		 Ixabepilone, 40 mg/m^2, IV Doxorubicin, 60 mg/m^2, IV Paclitaxel, 175 mg/m^2, IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    89 / 248 (35.89%)
    59 / 171 (34.50%)
    11 / 68 (16.18%)
         number of deaths (all causes)
    121
    76
    19
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial cancer
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Neoplasm malignant
         subjects affected / exposed
    4 / 248 (1.61%)
    5 / 171 (2.92%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 248 (0.40%)
    4 / 171 (2.34%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 248 (1.21%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    4 / 248 (1.61%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Performance status decreased
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 248 (1.61%)
    4 / 171 (2.34%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 248 (0.81%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 248 (0.00%)
    6 / 171 (3.51%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 248 (1.21%)
    1 / 171 (0.58%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 248 (1.21%)
    6 / 171 (3.51%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    3 / 248 (1.21%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 248 (0.00%)
    2 / 171 (1.17%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    2 / 248 (0.81%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 248 (1.21%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incorrect dose administered
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 248 (0.81%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 248 (2.02%)
    7 / 171 (4.09%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    10 / 248 (4.03%)
    10 / 171 (5.85%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    11 / 11
    9 / 10
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    3 / 248 (1.21%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    6 / 248 (2.42%)
    4 / 171 (2.34%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 248 (1.61%)
    6 / 171 (3.51%)
    2 / 68 (2.94%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 248 (1.21%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 248 (1.61%)
    4 / 171 (2.34%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Diarrhoea
         subjects affected / exposed
    9 / 248 (3.63%)
    2 / 171 (1.17%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    5 / 10
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 248 (0.40%)
    3 / 171 (1.75%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    2 / 248 (0.81%)
    2 / 171 (1.17%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    8 / 248 (3.23%)
    7 / 171 (4.09%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    5 / 12
    5 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 248 (0.40%)
    2 / 171 (1.17%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Rectal obstruction
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 248 (0.40%)
    2 / 171 (1.17%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    9 / 248 (3.63%)
    4 / 171 (2.34%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    8 / 14
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Intertrigo
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chromaturia
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal failure acute
         subjects affected / exposed
    2 / 248 (0.81%)
    2 / 171 (1.17%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 248 (0.00%)
    2 / 171 (1.17%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium bacteraemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 248 (0.00%)
    2 / 171 (1.17%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Infectious peritonitis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 248 (0.00%)
    3 / 171 (1.75%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory moniliasis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 248 (0.00%)
    0 / 171 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 248 (1.21%)
    2 / 171 (1.17%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    3 / 3
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 171 (0.58%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 248 (1.61%)
    3 / 171 (1.75%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Candidiasis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 248 (0.81%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    5 / 248 (2.02%)
    5 / 171 (2.92%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 171 (0.00%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ixabepilone, 40 mg/m^2, IV Doxorubicin, 60 mg/m^2, IV Paclitaxel, 175 mg/m^2, IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    233 / 248 (93.95%)
    160 / 171 (93.57%)
    63 / 68 (92.65%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    13 / 248 (5.24%)
    11 / 171 (6.43%)
    3 / 68 (4.41%)
         occurrences all number
    17
    19
    4
    Weight decreased
         subjects affected / exposed
    48 / 248 (19.35%)
    28 / 171 (16.37%)
    3 / 68 (4.41%)
         occurrences all number
    52
    31
    3
    Weight increased
         subjects affected / exposed
    3 / 248 (1.21%)
    2 / 171 (1.17%)
    4 / 68 (5.88%)
         occurrences all number
    3
    2
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    24 / 248 (9.68%)
    10 / 171 (5.85%)
    1 / 68 (1.47%)
         occurrences all number
    27
    11
    1
    Dysgeusia
         subjects affected / exposed
    23 / 248 (9.27%)
    18 / 171 (10.53%)
    1 / 68 (1.47%)
         occurrences all number
    29
    21
    1
    Headache
         subjects affected / exposed
    19 / 248 (7.66%)
    16 / 171 (9.36%)
    0 / 68 (0.00%)
         occurrences all number
    23
    24
    0
    Neuropathy peripheral
         subjects affected / exposed
    17 / 248 (6.85%)
    3 / 171 (1.75%)
    5 / 68 (7.35%)
         occurrences all number
    17
    3
    5
    Hypoaesthesia
         subjects affected / exposed
    3 / 248 (1.21%)
    1 / 171 (0.58%)
    6 / 68 (8.82%)
         occurrences all number
    4
    1
    8
    Paraesthesia
         subjects affected / exposed
    10 / 248 (4.03%)
    3 / 171 (1.75%)
    5 / 68 (7.35%)
         occurrences all number
    16
    3
    6
    Peripheral motor neuropathy
         subjects affected / exposed
    12 / 248 (4.84%)
    2 / 171 (1.17%)
    5 / 68 (7.35%)
         occurrences all number
    15
    2
    5
    Peripheral sensory neuropathy
         subjects affected / exposed
    79 / 248 (31.85%)
    10 / 171 (5.85%)
    29 / 68 (42.65%)
         occurrences all number
    88
    10
    37
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    62 / 248 (25.00%)
    46 / 171 (26.90%)
    16 / 68 (23.53%)
         occurrences all number
    83
    59
    17
    Leukopenia
         subjects affected / exposed
    35 / 248 (14.11%)
    25 / 171 (14.62%)
    6 / 68 (8.82%)
         occurrences all number
    98
    51
    8
    Lymphopenia
         subjects affected / exposed
    7 / 248 (2.82%)
    11 / 171 (6.43%)
    0 / 68 (0.00%)
         occurrences all number
    14
    15
    0
    Thrombocytopenia
         subjects affected / exposed
    16 / 248 (6.45%)
    12 / 171 (7.02%)
    2 / 68 (2.94%)
         occurrences all number
    28
    20
    3
    Neutropenia
         subjects affected / exposed
    58 / 248 (23.39%)
    68 / 171 (39.77%)
    11 / 68 (16.18%)
         occurrences all number
    106
    127
    16
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    39 / 248 (15.73%)
    24 / 171 (14.04%)
    11 / 68 (16.18%)
         occurrences all number
    51
    30
    15
    Fatigue
         subjects affected / exposed
    125 / 248 (50.40%)
    88 / 171 (51.46%)
    21 / 68 (30.88%)
         occurrences all number
    176
    117
    26
    Mucosal inflammation
         subjects affected / exposed
    21 / 248 (8.47%)
    28 / 171 (16.37%)
    0 / 68 (0.00%)
         occurrences all number
    26
    38
    0
    Oedema peripheral
         subjects affected / exposed
    27 / 248 (10.89%)
    20 / 171 (11.70%)
    6 / 68 (8.82%)
         occurrences all number
    27
    21
    7
    Pyrexia
         subjects affected / exposed
    17 / 248 (6.85%)
    22 / 171 (12.87%)
    4 / 68 (5.88%)
         occurrences all number
    18
    26
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    45 / 248 (18.15%)
    24 / 171 (14.04%)
    5 / 68 (7.35%)
         occurrences all number
    52
    26
    7
    Abdominal pain upper
         subjects affected / exposed
    7 / 248 (2.82%)
    14 / 171 (8.19%)
    1 / 68 (1.47%)
         occurrences all number
    11
    17
    2
    Constipation
         subjects affected / exposed
    77 / 248 (31.05%)
    49 / 171 (28.65%)
    7 / 68 (10.29%)
         occurrences all number
    118
    63
    7
    Dyspepsia
         subjects affected / exposed
    17 / 248 (6.85%)
    14 / 171 (8.19%)
    0 / 68 (0.00%)
         occurrences all number
    19
    14
    0
    Diarrhoea
         subjects affected / exposed
    76 / 248 (30.65%)
    47 / 171 (27.49%)
    8 / 68 (11.76%)
         occurrences all number
    113
    62
    13
    Nausea
         subjects affected / exposed
    118 / 248 (47.58%)
    101 / 171 (59.06%)
    17 / 68 (25.00%)
         occurrences all number
    190
    148
    30
    Stomatitis
         subjects affected / exposed
    16 / 248 (6.45%)
    18 / 171 (10.53%)
    1 / 68 (1.47%)
         occurrences all number
    23
    20
    2
    Vomiting
         subjects affected / exposed
    73 / 248 (29.44%)
    48 / 171 (28.07%)
    8 / 68 (11.76%)
         occurrences all number
    122
    70
    9
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    13 / 248 (5.24%)
    2 / 171 (1.17%)
    4 / 68 (5.88%)
         occurrences all number
    13
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    23 / 248 (9.27%)
    19 / 171 (11.11%)
    5 / 68 (7.35%)
         occurrences all number
    23
    19
    9
    Dyspnoea
         subjects affected / exposed
    37 / 248 (14.92%)
    33 / 171 (19.30%)
    8 / 68 (11.76%)
         occurrences all number
    40
    35
    8
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    102 / 248 (41.13%)
    63 / 171 (36.84%)
    36 / 68 (52.94%)
         occurrences all number
    103
    65
    36
    Rash
         subjects affected / exposed
    21 / 248 (8.47%)
    7 / 171 (4.09%)
    3 / 68 (4.41%)
         occurrences all number
    25
    7
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    11 / 248 (4.44%)
    13 / 171 (7.60%)
    1 / 68 (1.47%)
         occurrences all number
    11
    14
    1
    Insomnia
         subjects affected / exposed
    28 / 248 (11.29%)
    13 / 171 (7.60%)
    2 / 68 (2.94%)
         occurrences all number
    32
    17
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    46 / 248 (18.55%)
    9 / 171 (5.26%)
    22 / 68 (32.35%)
         occurrences all number
    66
    11
    76
    Muscular weakness
         subjects affected / exposed
    8 / 248 (3.23%)
    3 / 171 (1.75%)
    4 / 68 (5.88%)
         occurrences all number
    8
    3
    5
    Back pain
         subjects affected / exposed
    21 / 248 (8.47%)
    15 / 171 (8.77%)
    3 / 68 (4.41%)
         occurrences all number
    22
    17
    7
    Myalgia
         subjects affected / exposed
    32 / 248 (12.90%)
    4 / 171 (2.34%)
    17 / 68 (25.00%)
         occurrences all number
    62
    5
    56
    Pain in extremity
         subjects affected / exposed
    21 / 248 (8.47%)
    12 / 171 (7.02%)
    8 / 68 (11.76%)
         occurrences all number
    29
    12
    15
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    22 / 248 (8.87%)
    9 / 171 (5.26%)
    3 / 68 (4.41%)
         occurrences all number
    31
    9
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    82 / 248 (33.06%)
    45 / 171 (26.32%)
    12 / 68 (17.65%)
         occurrences all number
    104
    49
    16
    Dehydration
         subjects affected / exposed
    14 / 248 (5.65%)
    8 / 171 (4.68%)
    0 / 68 (0.00%)
         occurrences all number
    19
    12
    0
    Hypokalaemia
         subjects affected / exposed
    15 / 248 (6.05%)
    14 / 171 (8.19%)
    2 / 68 (2.94%)
         occurrences all number
    15
    17
    2
    Hypomagnesaemia
         subjects affected / exposed
    13 / 248 (5.24%)
    7 / 171 (4.09%)
    0 / 68 (0.00%)
         occurrences all number
    19
    8
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jul 2009
    The primary purpose of this amendment was to include additional cardiac function monitoring for subjects receiving doxorubicin to be in alignment with cardiac monitoring guidelines.
    05 Jan 2010
    The main purpose of this amendment was to change the dataset for the primary objective of progression-free survival to all randomised subjects, rather than the subset of subjects with measurable disease, to reflect the intent-to-treat population, in response to scientific advice obtained from the European Medicines Agency Committee for Medicinal Products for Human Use.
    15 Jun 2010
    The main purpose of this amendment was to further clarify eligibility with regard to prior chemotherapy. Subjects were eligible if they meet either criterion: Receipt of 1 prior chemotherapy regimen that included a platinum agent regardless of setting (adjuvant, neoadjuvant, metastatic, recurrent) or disease stage, or receipt of 2 prior chemotherapy regimens, with at least 1 regimen including a platinum agent, if 1 regimen was given for stage I or II disease.
    01 Oct 2010
    The main purpose of this amendment was to fully align the protocol with recommendations of the regulatory health authorities [US Food and Drug Administration and European Medicines Agency Committee for Medicinal Products for Human Use]. The primary endpoint of progression free survival was amended to overall survival.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated as per recommendation of Data Monitoring Committee as results from an interim analysis showed no favorable benefit/risk ratio for subjects and ixabepilone did not improve survival compared with control chemotherapies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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