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    Clinical Trial Results:
    BGOG-OV5:Phase II study of weekly Paclitaxel/Carboplatin in combination with prophylactic G-CSF in the treatment of gynaecological cancers.

    Summary
    EudraCT number
    		 2010-022482-95
    Trial protocol
    		 BE  
    Global end of trial date
    14 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Mar 2021
    First version publication date
    26 Mar 2021
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    BGOG-ov-5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Belgian Gynaecological Oncology Group
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Ignace Vergote, Belgian Gynaecological Oncology Group (BGOG), bgog@engot.eu
    Scientific contact
    Ignace Vergote, Belgian Gynaecological Oncology Group (BGOG), 0032 16347419, ignace.vergote@uzleuven.be
    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
    09 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    *to evaluate occurrence of grade 4 neutropenia during weekly paclitaxel/carboplatin with prophylactic G-CSF
    Protection of trial subjects
    Weekly monitoring adverse events - Hematology monitoring 3 weekly physical exams CT/MRI abdomen/thorax/pelvis
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 108
    Worldwide total number of subjects
    108
    EEA total number of subjects
    108
    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)
    64
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 FPI: 21-feb-2012 LPI: 27-mrt-2013

    Pre-assignment
    Screening details
    		 Screening criteria: - female over 18 years - ECOG 0-2 - Adequate organ function - Measurable disease Ovarian cohort: - invasive epithelial ovarian, fallopian tube or peritoneal carcninoma - 1 earlier platin treatment. Platin refractory Endometrium/cervical cohort: - Endometrial/ cervical carcinoma - recurrent or advanced

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 -
    Arm type
    		 Single arm

    Investigational medicinal product name
    Filgastrim
    Investigational medicinal product code
    Other name
    Neupogen
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Filgastrim 30 Mio U (0.600 mg/ml) for patients weighing less than 60kg Filgastrim 48 Mio U 0.5ml (0.960 mg/ml) for patients wieghing more than 60 kg Given on day 5 of each course. Courses will be repeated 18 times weekly except for course 10, which will be given 2 weeks after course 9

    Number of subjects in period 1
    		Overall trial
    Started
    108
    Completed
    108

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 108 108
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 64 64
        From 65-84 years
    		 44 44
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 60.2 ( 12.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 108 108
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients participating in the trial

    Subject analysis set title
    Endometrium
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Endometrial cancer cohort

    Subject analysis set title
    Ovarian
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Ovarian, fallopian tube and peritoneal carcinoma cohort

    Subject analysis set title
    Cervix
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Cervical carcinoma cohort

    Subject analysis sets values
    		 Overall trial Endometrium Ovarian Cervix
    Number of subjects
    108
    36
    36
    36
    Age categorical
    Units: Subjects
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (standard deviation)
    60.2 ( 12.28 )
    66.4 ( 9.86 )
    62.6 ( 10.48 )
    51.3 ( 11.43 )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Subject analysis set title
    Overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients participating in the trial

    Subject analysis set title
    Endometrium
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Endometrial cancer cohort

    Subject analysis set title
    Ovarian
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Ovarian, fallopian tube and peritoneal carcinoma cohort

    Subject analysis set title
    Cervix
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Cervical carcinoma cohort

    Primary: Overall Grade 3/4 neutrophenia

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    End point title
    		 Overall Grade 3/4 neutrophenia [1]
    End point description
    Patients were scored positive on Grade 3/4 neutrophenia if they had at least one AE specified as 'Neutrophil count decreased' in combination with a severity level equal to 3 or 4.
    End point type
    Primary
    End point timeframe
    Overall trial period
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparison between different groups were possible for the overall trial. The overall number en proportion of patients with grade 3/4 neutropenia were compared with historical data. A formal test shows that the occurence of grade3/4 neutropenia is lower compared to historical data (84%)
    End point values
    		 Overall trial
    Number of subjects analysed
    102
    Units: Grade 3/4 neutropenia
        number (confidence interval 95%)
    0.343 (0.258 to 0.439)
    No statistical analyses for this end point

    Secondary: Grade 3/4 neutropenia cohort

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    End point title
    		 Grade 3/4 neutropenia cohort
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial period
    End point values
    		 Endometrium Ovarian Cervix
    Number of subjects analysed
    33
    35
    34
    Units: Grade 3/4 neutropenia
        number (confidence interval 95%)
    0.364 (0.222 to 0.534)
    0.286 (0.163 to 0.451)
    0.382 (0.239 to 0.550)
    No statistical analyses for this end point

    Secondary: Overall Response rate (CR+PR)

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    End point title
    		 Overall Response rate (CR+PR)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Overall trial
    Number of subjects analysed
    93
    Units: Patients
        number (confidence interval 95%)
    0.505 (0.406 to 0.605)
    No statistical analyses for this end point

    Secondary: Confirmed response rate (CR+PR)

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    End point title
    		 Confirmed response rate (CR+PR)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Overall trial
    Number of subjects analysed
    93
    Units: Patients
        number (confidence interval 95%)
    0.280 (0.199 to 0.378)
    No statistical analyses for this end point

    Secondary: Unconfirmed response rate (CR+PR)

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    End point title
    		 Unconfirmed response rate (CR+PR)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Overall trial
    Number of subjects analysed
    93
    Units: Patients
        number (confidence interval 95%)
    0.226 (0.153 to 0.321)
    No statistical analyses for this end point

    Secondary: Overall response rate (CR+PR) cohort

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    End point title
    		 Overall response rate (CR+PR) cohort
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Endometrium Ovarian Cervix
    Number of subjects analysed
    29
    31
    33
    Units: Patients
        number (confidence interval 95%)
    0.448 (0.284 to 0.625)
    0.484 (0.320 to 0.652)
    0.576 (0.408 to 0.728)
    No statistical analyses for this end point

    Secondary: Confirmed response rate (CR+PR) cohort

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    End point title
    		 Confirmed response rate (CR+PR) cohort
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Endometrium Ovarian Cervix
    Number of subjects analysed
    29
    31
    33
    Units: Patients
        number (confidence interval 95%)
    0.207 (0.098 to 0.384)
    0.290 (0.161 to 0.466)
    0.333 (0.198 to 0.504)
    No statistical analyses for this end point

    Secondary: Unconfirmed reponse rate (CR+PR) cohort

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    End point title
    		 Unconfirmed reponse rate (CR+PR) cohort
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Endometrium Ovarian Cervix
    Number of subjects analysed
    29
    31
    33
    Units: Patients
        number (confidence interval 95%)
    0.241 (0.122 to 0.421)
    0.194 (0.092 to 0.363)
    0.242 (0.128 to 0.410)
    No statistical analyses for this end point

    Secondary: Median overall survival

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    End point title
    		 Median overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Overall trial
    Number of subjects analysed
    102
    Units: Months
        median (confidence interval 95%)
    12.70 (10.23 to 16.25)
    No statistical analyses for this end point

    Secondary: Median overall survival cohort

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    End point title
    		 Median overall survival cohort
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Endometrium Ovarian Cervix
    Number of subjects analysed
    33
    35
    34
    Units: months
        median (confidence interval 95%)
    18.52 (7.70 to 99999)
    12.66 (8.42 to 19.21)
    13.62 (10.13 to 16.25)
    No statistical analyses for this end point

    Secondary: Median Progression Free Survival

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    End point title
    		 Median Progression Free Survival
    End point description
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Overall trial Endometrium Ovarian Cervix
    Number of subjects analysed
    102
    33
    35
    34
    Units: Months
        median (confidence interval 95%)
    7.14 (5.13 to 8.09)
    5.66 (3.95 to 8.55)
    7.47 (5.79 to 8.39)
    5.69 (4.38 to 10.26)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group title
    Ovarium Cancer
    Reporting group description
    		 -

    Reporting group title
    Endometrium
    Reporting group description
    		 -

    Reporting group title
    Cervix
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial Ovarium Cancer Endometrium Cervix
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 108 (38.89%)
    14 / 36 (38.89%)
    14 / 36 (38.89%)
    13 / 36 (36.11%)
         number of deaths (all causes)
    11
    5
    5
    1
         number of deaths resulting from adverse events
    3
    0
    3
    0
    Vascular disorders
    Thromboembolitic event
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Colostomy problems
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    Fever
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General Weakness
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Social problem
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Vaginal pain
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angor
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Depressed level of consciousness
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction
         subjects affected / exposed
    5 / 108 (4.63%)
    2 / 36 (5.56%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Fistula of small intestine
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula
    Additional description: ileo-vaginal-bladder fistula
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erysipelas
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    5 / 108 (4.63%)
    0 / 36 (0.00%)
    5 / 36 (13.89%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Catheter related infection
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    Sepsis
         subjects affected / exposed
    4 / 108 (3.70%)
    3 / 36 (8.33%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 3
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash pustular
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial Ovarium Cancer Endometrium Cervix
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    104 / 108 (96.30%)
    36 / 36 (100.00%)
    33 / 36 (91.67%)
    35 / 36 (97.22%)
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    7 / 108 (6.48%)
    1 / 36 (2.78%)
    4 / 36 (11.11%)
    2 / 36 (5.56%)
         occurrences all number
    7
    1
    4
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    81 / 108 (75.00%)
    31 / 36 (86.11%)
    22 / 36 (61.11%)
    28 / 36 (77.78%)
         occurrences all number
    188
    73
    36
    79
    Fever
         subjects affected / exposed
    9 / 108 (8.33%)
    2 / 36 (5.56%)
    2 / 36 (5.56%)
    5 / 36 (13.89%)
         occurrences all number
    11
    4
    2
    5
    Pain
         subjects affected / exposed
    25 / 108 (23.15%)
    7 / 36 (19.44%)
    7 / 36 (19.44%)
    11 / 36 (30.56%)
         occurrences all number
    36
    13
    9
    14
    Oedema
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    1
    1
    Asthenia
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Malaise
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    0
    1
    Haemorrhage
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    General physical health deterioration
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    4
    2
    0
    2
    Infusion related reaction
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    15 / 108 (13.89%)
    8 / 36 (22.22%)
    5 / 36 (13.89%)
    2 / 36 (5.56%)
         occurrences all number
    19
    8
    9
    2
    Reproductive system and breast disorders
    Vaginal pain
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    3
    0
    0
    3
    Vaginal infection
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    4
    1
    0
    3
    Vaginal dryness
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Vaginal atrophy
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    21 / 108 (19.44%)
    7 / 36 (19.44%)
    5 / 36 (13.89%)
    9 / 36 (25.00%)
         occurrences all number
    46
    31
    5
    10
    Dyspnoea
         subjects affected / exposed
    29 / 108 (26.85%)
    10 / 36 (27.78%)
    7 / 36 (19.44%)
    12 / 36 (33.33%)
         occurrences all number
    38
    12
    11
    15
    Pulmonary embolism
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
         occurrences all number
    4
    1
    1
    2
    Respiratory failure
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Laryngeal inflammation
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    1
    1
    Hoarseness
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    8 / 108 (7.41%)
    3 / 36 (8.33%)
    3 / 36 (8.33%)
    2 / 36 (5.56%)
         occurrences all number
    9
    4
    3
    2
    Agitation
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Alternation of general status
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Confusional state
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Depression
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Emotional distress
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Insomnia
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    1
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    59 / 108 (54.63%)
    16 / 36 (44.44%)
    17 / 36 (47.22%)
    26 / 36 (72.22%)
         occurrences all number
    160
    37
    59
    64
    Platelet count decreased
         subjects affected / exposed
    64 / 108 (59.26%)
    16 / 36 (44.44%)
    21 / 36 (58.33%)
    27 / 36 (75.00%)
         occurrences all number
    332
    83
    114
    135
    White blood cell count decreased
         subjects affected / exposed
    24 / 108 (22.22%)
    9 / 36 (25.00%)
    5 / 36 (13.89%)
    10 / 36 (27.78%)
         occurrences all number
    78
    32
    19
    27
    Bilirubin conjugated increased
         subjects affected / exposed
    5 / 108 (4.63%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    3 / 36 (8.33%)
         occurrences all number
    10
    4
    2
    4
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    14
    4
    0
    10
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    6
    3
    0
    3
    Creatinine urine increased
         subjects affected / exposed
    6 / 108 (5.56%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    4 / 36 (11.11%)
         occurrences all number
    10
    1
    2
    7
    Ferritine decreased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Alkaline phosphatase increased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    GGT increased
         subjects affected / exposed
    7 / 108 (6.48%)
    1 / 36 (2.78%)
    4 / 36 (11.11%)
    2 / 36 (5.56%)
         occurrences all number
    7
    1
    4
    2
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    0
    0
    3
    Injury, poisoning and procedural complications
    Fracture
    Additional description: Fracture toe Fracture cotyle right
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    3
    1
    2
    0
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    2
    0
    1
    Atrial flutter
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nervous system disorders
    Paresthesia
         subjects affected / exposed
    7 / 108 (6.48%)
    2 / 36 (5.56%)
    3 / 36 (8.33%)
    2 / 36 (5.56%)
         occurrences all number
    8
    2
    4
    2
    Peripheral motor neuropathy
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    3
    2
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    36 / 108 (33.33%)
    10 / 36 (27.78%)
    10 / 36 (27.78%)
    16 / 36 (44.44%)
         occurrences all number
    46
    11
    11
    23
    Dysgeusia
         subjects affected / exposed
    3 / 108 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
         occurrences all number
    4
    0
    1
    3
    Amnesia
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Cerebrovascular accident
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Dizziness
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    2
    0
    1
    Tremor
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Presyncope
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    0
    2
    Syncope
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    2
    0
    1
    Spasms
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Headache
         subjects affected / exposed
    7 / 108 (6.48%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    5 / 36 (13.89%)
         occurrences all number
    7
    1
    1
    5
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    88 / 108 (81.48%)
    28 / 36 (77.78%)
    26 / 36 (72.22%)
    34 / 36 (94.44%)
         occurrences all number
    392
    108
    103
    181
    Febrile neutropenia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hypertension
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences all number
    6
    3
    2
    1
    Hypotension
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Tinnitus
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hearing impaired
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    1
    1
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    0
    2
    Watering eyes
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Optic nerve disorder
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    68 / 108 (62.96%)
    22 / 36 (61.11%)
    21 / 36 (58.33%)
    25 / 36 (69.44%)
         occurrences all number
    117
    38
    38
    41
    Vomiting
         subjects affected / exposed
    32 / 108 (29.63%)
    13 / 36 (36.11%)
    10 / 36 (27.78%)
    9 / 36 (25.00%)
         occurrences all number
    51
    20
    11
    20
    Diarrhoea
         subjects affected / exposed
    44 / 108 (40.74%)
    17 / 36 (47.22%)
    13 / 36 (36.11%)
    14 / 36 (38.89%)
         occurrences all number
    65
    30
    17
    18
    Constipation
         subjects affected / exposed
    30 / 108 (27.78%)
    7 / 36 (19.44%)
    11 / 36 (30.56%)
    12 / 36 (33.33%)
         occurrences all number
    34
    9
    12
    13
    Abdominal pain
         subjects affected / exposed
    18 / 108 (16.67%)
    4 / 36 (11.11%)
    4 / 36 (11.11%)
    10 / 36 (27.78%)
         occurrences all number
    20
    5
    4
    11
    Anorexia nervosa
         subjects affected / exposed
    25 / 108 (23.15%)
    8 / 36 (22.22%)
    8 / 36 (22.22%)
    9 / 36 (25.00%)
         occurrences all number
    29
    9
    9
    11
    hemorrhoides
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Stomach Pain
         subjects affected / exposed
    3 / 108 (2.78%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences all number
    3
    0
    2
    1
    Anal fissure
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Ascites
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Obstruction
         subjects affected / exposed
    7 / 108 (6.48%)
    3 / 36 (8.33%)
    2 / 36 (5.56%)
    2 / 36 (5.56%)
         occurrences all number
    10
    4
    3
    3
    Colitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Dysphagia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Oesophagitis
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Toothache
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastritis
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    1
    1
    Stomatitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Ileus
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Mucositis oral
         subjects affected / exposed
    4 / 108 (3.70%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    6
    2
    2
    2
    Fistula
    Additional description: cervico-bladder female genital tract
         subjects affected / exposed
    4 / 108 (3.70%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    5
    1
    0
    4
    Gastroenteritis
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    21 / 108 (19.44%)
    10 / 36 (27.78%)
    5 / 36 (13.89%)
    6 / 36 (16.67%)
         occurrences all number
    25
    10
    7
    8
    Nail loss
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Rosacea
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Acute Renal insufficiency
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cystitis
         subjects affected / exposed
    4 / 108 (3.70%)
    0 / 36 (0.00%)
    3 / 36 (8.33%)
    1 / 36 (2.78%)
         occurrences all number
    4
    0
    3
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Pyelonephritis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Renal failure
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nocturia
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Prerenal failure
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle discomfort
         subjects affected / exposed
    7 / 108 (6.48%)
    4 / 36 (11.11%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
         occurrences all number
    7
    4
    2
    1
    Muscle strength abnormal
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    1
    1
    Myalgia
         subjects affected / exposed
    9 / 108 (8.33%)
    3 / 36 (8.33%)
    1 / 36 (2.78%)
    5 / 36 (13.89%)
         occurrences all number
    10
    3
    1
    6
    Arthralgia
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    1
    1
    Back pain
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    4
    3
    1
    0
    Bone pain
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    3
    0
    0
    3
    Flank pain
         subjects affected / exposed
    3 / 108 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
         occurrences all number
    3
    0
    1
    2
    Pain in extremity
         subjects affected / exposed
    2 / 108 (1.85%)
    2 / 36 (5.56%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Buttock pain
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pelvic pain
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    1
    1
    Pain footh
         subjects affected / exposed
    3 / 108 (2.78%)
    2 / 36 (5.56%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    3
    2
    1
    0
    Soft tissue necrosis
    Additional description: upper limb
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    7 / 108 (6.48%)
    3 / 36 (8.33%)
    1 / 36 (2.78%)
    3 / 36 (8.33%)
         occurrences all number
    10
    4
    1
    5
    Sepsis
         subjects affected / exposed
    7 / 108 (6.48%)
    3 / 36 (8.33%)
    2 / 36 (5.56%)
    2 / 36 (5.56%)
         occurrences all number
    8
    3
    2
    3
    Bladder infection
         subjects affected / exposed
    3 / 108 (2.78%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    3
    1
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    21 / 108 (19.44%)
    8 / 36 (22.22%)
    9 / 36 (25.00%)
    4 / 36 (11.11%)
         occurrences all number
    25
    9
    11
    5
    Catheter related infection
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    3
    0
    Wound infection
    Additional description: Umbilicale wound infection
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Sinusitis
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    4
    0
    0
    4
    Rhinitis
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    1
    1
    Peritonitis
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Lip infection
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Bacterial infection
    Additional description: MRSA positive
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    1
    0
    0
    1
    Infection
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    3
    0
    0
    3
    Laryngitis
         subjects affected / exposed
    2 / 108 (1.85%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    1
    1
    Inflammatory syndrom
         subjects affected / exposed
    1 / 108 (0.93%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    0
    0
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    21 / 108 (19.44%)
    8 / 36 (22.22%)
    4 / 36 (11.11%)
    9 / 36 (25.00%)
         occurrences all number
    53
    34
    5
    14
    Hypomagnesaemia
         subjects affected / exposed
    15 / 108 (13.89%)
    6 / 36 (16.67%)
    4 / 36 (11.11%)
    5 / 36 (13.89%)
         occurrences all number
    23
    7
    7
    9
    Hypocalcaemia
         subjects affected / exposed
    2 / 108 (1.85%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    5
    4
    0
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 108 (0.93%)
    1 / 36 (2.78%)
    0 / 36 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    3 / 108 (2.78%)
    0 / 36 (0.00%)
    1 / 36 (2.78%)
    2 / 36 (5.56%)
         occurrences all number
    4
    0
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26049123
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    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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