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    Clinical Trial Results:
    Intravenous ferric carboxymaltose vs. oral iron substitution in patients with metastatic colorectal cancer (CRC) and iron deficiency anemia: a randomized multicenter treatment optimization study.

    Summary
    EudraCT number
    		 2014-000246-30
    Trial protocol
    		 DE  
    Global end of trial date
    04 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2023
    First version publication date
    21 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FERINJECT
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest
    Sponsor organisation address
    Steinbacher Hohl 2-26, Frankfurt am Main Mitte-West, Frankfurt am Main, Germany, 60488
    Public contact
    Prof. Al-Batran, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, info@ikf-khnw.de
    Scientific contact
    Prof. Al-Batran, Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest, info@ikf-khnw.de
    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
    27 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the trial was to estimate the treatment response of intravenous iron carboxymaltose versus oral iron replacement in patients with metastatic colorectal cancer (CRC) and iron deficiency anemia. The primary endpoint was the response rate defined as proportion of patients with either an increase in serum hemoglobin by 2 g/dl or normalization of serum hemoglobin (12 g/dl) within 12 weeks from baseline. Secondary objectives of the trial were to further compare intravenous iron carboxymaltose versus oral iron replacement in terms of efficacy and safety.
    Protection of trial subjects
    This clinical study was designed and shall be implemented and reported in accordance with the protocol, the AMG (Arzneimittelgesetz), the ICH Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations (including European Directive 2001/20/EC), and with the ethical principles laid down in the Declaration of Helsinki. The trial was authorized/approved by the competent authority (Paul-Ehrlich-Institut, PEI) and the competent ethics committee responsible for the trial (“federführende Ethikkommission”). Before recruitment into the clinical trial, each patient was informed that participation in the study is completely voluntary, and that he or she may withdraw his or her participation in the trial at any time without any declaration of reasons, which will not lead to any disadvantage for the respective patient. The eligibility of a new patient was determined by the local investigator during regular clinical visits. The examinations for the study and the inclusion of the patient were done after detailed written and oral education about aims, methods, anticipated benefits and potential hazards of the study by use of the informed consent forms and after given written consent of the patient. Safety of the trial treatment was monitored continuously by careful monitoring of all adverse events (AEs) and serious adverse events (SAEs) reported. An independent data safety monitoring board (DSMB) was responsible for assessment of reports summarizing safety data or study results and gave recommendations for planned protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2015
    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
    Germany: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    27
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May 2015 and Feb 2019, 64 patients from 12 centers in Germany were enrolled. Eligible patients were stratified by ferritin (≤30 versus >30 ng/ml), ECOG (0 versus 1/2) and palliative treatment line (1 versus ≥2) and randomized 1:1.

    Pre-assignment
    Screening details
    		 Main criteria for inclusion: Metastatic or inoperable colorectal carcinoma, no curative therapy available, current palliative chemotherapy, Iron deficiency anemia: hemoglobin ≤ 10.5 g/dl and transferrin saturation < 20 % and/or serum ferritin < 20 ng/mL, body weight ≥ 40 kg

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FerInject
    Arm description
    		 Patients received once intravenous substitution with ferric carboxymaltose (Ferinject); max. 2000 mg over 2 weeks (max. 1000 mg per week). In addition, oral folic acid and vitamin B-12 substitution was applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferinject
    Investigational medicinal product code
    Other name
    ferric carboxymaltose
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use, Infusion , Injection
    Dosage and administration details
    Patients with 40-69 kg body weight: Hb < 10 g/dL --> 1500 mg Ferinject; Hb ≥ 10 g/dL --> 1000 mg Ferinject Patients with ≥ 70 kg body weight: Hb < 10 g/dL --> 2000 mg Ferinject; Hb ≥ 10 g/dL --> 1500 mg Ferinject Infusion over at least 6 min (500 mg) or respectively 15 min (1000 mg). The maximum recommended cumulative dose of Ferinject was 1000 mg per week, total dose was applied within a maximum of 2 weeks.

    Arm title
    		 Oral Fe substitution
    Arm description
    		 Patients received 200 mg oral per day over 12 weeks. In addition, oral folic acid and vitamin B-12 substitution was applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferro sanol duodenal
    Investigational medicinal product code
    Other name
    Eisen(II)-glycin-sulfat-Komplex
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg per day (2 capsule per 100 mg) on empty stomach (e.g. in the morning and evening 1 hour before melas)

    Number of subjects in period 1
    		FerInject Oral Fe substitution
    Started
    32
    32
    Completed
    26
    20
    Not completed
    6
    12
         Physician decision
    -
    2
         Patient's wish
    1
    3
         Adverse event, non-fatal
    -
    3
         Death
    1
    -
         Other
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FerInject
    Reporting group description
    		 Patients received once intravenous substitution with ferric carboxymaltose (Ferinject); max. 2000 mg over 2 weeks (max. 1000 mg per week). In addition, oral folic acid and vitamin B-12 substitution was applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.

    Reporting group title
    Oral Fe substitution
    Reporting group description
    		 Patients received 200 mg oral per day over 12 weeks. In addition, oral folic acid and vitamin B-12 substitution was applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.

    Reporting group values
    		 FerInject Oral Fe substitution Total
    Number of subjects
    		 32 32 64
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 67.5 (31 to 81) 67.5 (41 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 13 15 28
        Male
    		 19 17 36
    ECOG performance status
    Units: Subjects
        ECOG 0
    		 10 10 20
        ECOG 1
    		 19 20 39
        ECOG 2
    		 3 2 5
    Primary localisation
    Units: Subjects
        Colon
    		 19 19 38
        Rectum
    		 12 13 25
        Missing
    		 1 0 1
    T stage
    Units: Subjects
        T0
    		 1 0 1
        T2
    		 2 2 4
        T3
    		 16 17 33
        T4
    		 9 6 15
        Tx
    		 3 6 9
        Missing
    		 1 1 2
    N stage
    Units: Subjects
        N0
    		 5 7 12
        N1
    		 10 6 16
        N2
    		 10 12 22
        Nx
    		 6 6 12
        Missing
    		 1 1 2
    M stage
    Units: Subjects
        M0
    		 5 2 7
        M1
    		 27 29 56
        Missing
    		 0 1 1
    Number prior palliative therapy lines
    without current therapy
    Units: Subjects
        Zero
    		 14 13 27
        One
    		 10 13 23
        Two
    		 4 4 8
        Three
    		 2 1 3
        Four
    		 2 0 2
        Six
    		 0 1 1
    Prior Fe substitution within last 6 months
    Units: Subjects
        Yes
    		 1 2 3
        No
    		 31 30 61
    Substitution with packed red blood cells
    Median number of red blood cells substitution was 2.0 (2-8) in the Ferinject Arm and 2.0 (1-8)in the Oral Fe Arm
    Units: Subjects
        Yes
    		 5 5 10
        No
    		 26 27 53
        Missing
    		 1 0 1
    Substitution with erythropoietin
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 31 31 62
        Missing
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    FerInject
    Reporting group description
    		 Patients received once intravenous substitution with ferric carboxymaltose (Ferinject); max. 2000 mg over 2 weeks (max. 1000 mg per week). In addition, oral folic acid and vitamin B-12 substitution was applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.

    Reporting group title
    Oral Fe substitution
    Reporting group description
    		 Patients received 200 mg oral per day over 12 weeks. In addition, oral folic acid and vitamin B-12 substitution was applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.

    Primary: Response Rate

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    End point title
    		 Response Rate
    End point description
    End point type
    Primary
    End point timeframe
    The response rate defined as proportion of patients with either an increase in serum hemoglobin by 2 g/dl or normalization of serum hemoglobin (12 g/dl) within 12 weeks from baseline
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    32
    32
    Units: subjects
        Yes
    18
    13
        No
    13
    19
        Missing
    1
    0
    Statistical analysis title
    		 Fishers Exact Test
    Comparison groups
    FerInject v Oral Fe substitution
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.211
    Method
    		 Fisher exact
    Confidence interval

    Primary: Response Rate Per-Protocol Set

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    End point title
    		 Response Rate Per-Protocol Set
    End point description
    This set contains all eligible patients, who fulfilled all inclusion/exclusion criteria, and received at least one application of protocol treatment and for whom baseline hemoglobin (Hb) data as well as further Hb-data after at least 4 weeks of start of protocol treatment were available.
    End point type
    Primary
    End point timeframe
    within 12 weeks from baseline
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    28
    25
    Units: Subjects
        Yes
    17
    13
        No
    11
    12
        Missing
    0
    0
    Statistical analysis title
    		 Fisher Exact Test
    Comparison groups
    FerInject v Oral Fe substitution
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5862
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Time to response

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    End point title
    		 Time to response
    End point description
    The median time to response in both arms was 3.0 month
    End point type
    Secondary
    End point timeframe
    Calculated from the date of study enrolment until the date of increase or normalization of hemoglobin. Only subjects with an event were analyzed.
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    31
    32
    Units: Subjects
        Response
    18
    13
        No Response
    13
    19
    Attachments
    		 Untitled (Filename: Time to response.png)
    Statistical analysis title
    		 Log Rank Test
    Comparison groups
    Oral Fe substitution v FerInject
    Number of subjects included in analysis
    63
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1875
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.658
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.322
         upper limit
    		 1.345

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    Median Overalls survival was 13 months [95% CI 9,25] in the FerInject Arm and 21 months [14, not estimable] in the aral FE substitution arm
    End point type
    Secondary
    End point timeframe
    from time of randomization to date of last follow-up
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    32
    32
    Units: Subjects
        Death
    19
    16
        Alive
    13
    16
    Attachments
    		 Untitled (Filename: Overall survival.png)
    Statistical analysis title
    		 Log Rank Test
    Comparison groups
    Oral Fe substitution v FerInject
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2573
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.682
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.345
         upper limit
    		 1.347

    Secondary: Hand force maesurements

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    End point title
    		 Hand force maesurements
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline till end of treatment
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    17
    16
    Units: Units
    arithmetic mean (standard deviation)
        Baseline
    31.5 ± 5.9
    30.9 ± 12.2
        Change over baseline on Visit 7/EOT
    0.9 ± 4.8
    0.9 ± 4.2
    No statistical analyses for this end point

    Secondary: Nutrition Risk Score

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    End point title
    		 Nutrition Risk Score
    End point description
    nutrition risk score indicates a nutrition risk by a score of 3 and higher
    End point type
    Secondary
    End point timeframe
    from baseline till end of treatment
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    14
    14
    Units: unit(s)
    arithmetic mean (standard deviation)
        Baseline
    2 ± 1.3
    2.1 ± 0.9
        Change over baseline at visit 7/EOT
    0 ± 0.8
    0.3 ± 2.1
    No statistical analyses for this end point

    Secondary: EORCT QLQ C30 - Mean change from baseline at EOT

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    End point title
    		 EORCT QLQ C30 - Mean change from baseline at EOT
    End point description
    End point type
    Secondary
    End point timeframe
    from baseline till end of treatment
    End point values
    		 FerInject Oral Fe substitution
    Number of subjects analysed
    30
    27
    Units: unit(s)
    arithmetic mean (standard deviation)
        Global Health Status
    3.2 ± 20.7
    4.9 ± 22.1
        Physical Functioning
    2.8 ± 21.1
    1.4 ± 16.6
        Role Functioning
    3.2 ± 33.3
    -3.6 ± 30.5
        Emotional Functioning
    -0.2 ± 22.4
    2.2 ± 15.3
        Cognitive Functioning
    -2.6 ± 19.8
    0.7 ± 16.3
        Social Functioning
    13.5 ± 30.9
    4.3 ± 23.1
        Fatigue
    -7.9 ± 24.8
    -11.6 ± 21.6
        Nausea/Vomiting
    2.6 ± 22
    -1.4 ± 11.1
        Pain
    0 ± 36.5
    -2.2 ± 25.8
        Dyspnea
    -13.3 ± 25.5
    1.5 ± 26.2
        Insomnia
    5.1 ± 36.1
    0 ± 20.1
        Appetite Loss
    -5.1 ± 41.8
    -10.1 ± 32.5
        Constipation
    -4 ± 35.1
    -6.1 ± 43.2
        Diarrhea
    -6.7 ± 34.7
    -4.3 ± 30.7
        Financial Difficulties
    -2.6 ± 20.9
    -10.1 ± 21.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were monitored from baseline till end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    FerInject
    Reporting group description
    		 Patients received once intravenous substitution with ferric carboxymaltose (Ferinject); max. 2000 mg over 2 weeks (max. 1000 mg per week). In addition, oral folic acid and vitamin B-12 substitution is applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.

    Reporting group title
    Oral Fe substitution
    Reporting group description
    		 Patients receive 200 mg oral per day over 12 weeks. In addition, oral folic acid and vitamin B-12 substitution is applied in both study arms. Folic acid 400 µg per day and vitamin B-12 10 µg per day.

    Serious adverse events
    		 FerInject Oral Fe substitution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 31 (29.03%)
    8 / 30 (26.67%)
         number of deaths (all causes)
    1
    16
         number of deaths resulting from adverse events
    1
    1
    Vascular disorders
    Arteria femoralis superficialis stenose
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Insufficiency
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: with gastrointestinal bleeding
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
    Additional description: progressive disease
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bile duct stenosis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Inflammation
    Additional description: toe interdigits inflamed
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumboischialgia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection of port system
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FerInject Oral Fe substitution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 31 (100.00%)
    29 / 30 (96.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    4 / 31 (12.90%)
    0 / 30 (0.00%)
         occurrences all number
    4
    0
    Edema limbs
         subjects affected / exposed
    6 / 31 (19.35%)
    3 / 30 (10.00%)
         occurrences all number
    6
    3
    Fatigue
         subjects affected / exposed
    11 / 31 (35.48%)
    8 / 30 (26.67%)
         occurrences all number
    12
    12
    General physical health deterioration
         subjects affected / exposed
    5 / 31 (16.13%)
    2 / 30 (6.67%)
         occurrences all number
    5
    2
    Pain
         subjects affected / exposed
    7 / 31 (22.58%)
    4 / 30 (13.33%)
         occurrences all number
    9
    5
    Weight decreased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 31 (22.58%)
    5 / 30 (16.67%)
         occurrences all number
    7
    5
    Dyspnoea
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 30 (13.33%)
         occurrences all number
    4
    6
    Epistaxis
         subjects affected / exposed
    6 / 31 (19.35%)
    2 / 30 (6.67%)
         occurrences all number
    10
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    8 / 31 (25.81%)
    3 / 30 (10.00%)
         occurrences all number
    11
    3
    White blood cell count decreased
         subjects affected / exposed
    5 / 31 (16.13%)
    1 / 30 (3.33%)
         occurrences all number
    5
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 30 (3.33%)
         occurrences all number
    3
    1
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    7 / 31 (22.58%)
    5 / 30 (16.67%)
         occurrences all number
    7
    5
    Dizziness
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 31 (25.81%)
    3 / 30 (10.00%)
         occurrences all number
    11
    4
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Constipation
         subjects affected / exposed
    5 / 31 (16.13%)
    5 / 30 (16.67%)
         occurrences all number
    7
    5
    Diarrhoea
         subjects affected / exposed
    9 / 31 (29.03%)
    8 / 30 (26.67%)
         occurrences all number
    9
    15
    Mucositis oral
         subjects affected / exposed
    3 / 31 (9.68%)
    4 / 30 (13.33%)
         occurrences all number
    3
    5
    Nausea
         subjects affected / exposed
    10 / 31 (32.26%)
    7 / 30 (23.33%)
         occurrences all number
    12
    7
    Vomiting
         subjects affected / exposed
    5 / 31 (16.13%)
    0 / 30 (0.00%)
         occurrences all number
    5
    0
    Ascites
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Asthenia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 31 (9.68%)
    2 / 30 (6.67%)
         occurrences all number
    3
    2
    Dry skin
         subjects affected / exposed
    7 / 31 (22.58%)
    3 / 30 (10.00%)
         occurrences all number
    8
    5
    Rash acneiform
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 30 (3.33%)
         occurrences all number
    4
    1
    Palmar-plantar erythrodysesthesia syndrome
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 30 (0.00%)
         occurrences all number
    4
    0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    4 / 31 (12.90%)
    4 / 30 (13.33%)
         occurrences all number
    5
    7
    Hypokalaemia
         subjects affected / exposed
    4 / 31 (12.90%)
    1 / 30 (3.33%)
         occurrences all number
    4
    2

    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
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