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    Clinical Trial Results:
    An open label study to determine the efficacy of ferric carboxymaltose in preoperative colorectal cancer related anaemia, and to develop biomarkers to predict response to this treatment strategy

    Summary
    EudraCT number
    		 2011-002185-21
    Trial protocol
    		 GB  
    Global end of trial date
    08 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Sep 2016
    First version publication date
    15 Sep 2016
    Other versions
    Summary report(s)
    		 End of study report

    Trial information

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    Trial identification
    Sponsor protocol code
    11GS005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC reference number: 11/EM/0237
    Sponsors
    Sponsor organisation name
    Nottingham University Hospitals
    Sponsor organisation address
    Derby Road, Nottingham, United Kingdom, NG7 2UH
    Public contact
    Rachelle Ward, Nottingham University Hospitals, +44 115 924 9924 x70258, Rachelle.Ward@nuh.nhs.uk
    Scientific contact
    Rachelle Ward, Nottingham University Hospitals, +44 115 924 9924 x70258, Rachelle.Ward@nuh.nhs.uk
    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 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research question is can we reduce the need for peri-operative allogeneic blood transfusion in the treatment group (intravenous ferric carboxymaltose) compared to the control group (oral ferrous sulphate)?
    Protection of trial subjects
    We have conducted this study in full conformity with relevant regulations and with the ICH Guidelines for Good Clinical Practice (CPMP/ICH/135/95) July 1996, Good Clinical Practices (GCP) and Nottingham University Hospitals NHS Trust (NUH) Research and Innovation (R&I) Procedures. The protocol, informed consent form, participant information sheet and any proposed advertising material was submitted to the Research Ethics Committee (REC), regulatory authorities (MHRA in the UK), and host institution(s) for written approval. We obtained approval from the above parties for the study. In this trial, both the intervention and control group received iron in order to treat the anaemia pre-operatively. Therefore, there was no non-treatment of the participants. There were clear guidelines that the clinicians should adhere to when considering transfusion for the participants in this trial. However, the guidelines could be overruled in any situation where the clinician feels that the clinical situation requires a different management from that detailed in the guidelines. This study did not involve any vulnerable participants and all participants had to be able to give valid, informed consent to be enrolled in this trial.
    Background therapy
    		 All subjects for this study are undergoing colorectal surgery to remove histologically colorectal adenocarcinoma. They were all received standard anaethesia, surgical bowel resection and post-operative care.
    Evidence for comparator
    		 Oral iron supplementation and allogeneic blood transfusion are the current standard practice of treatment for pre-operative anaemia. Pre-operative oral iron supplementation has been proven to be effective in the treatment of anaemia and for reducing the need for blood transfusion in colorectal surgery. It is cheap, widely available and easily administered. However, oral iron is associated with a number of gastrointestinal side-effects such as abdominal pain, constipation, diarrhoea and dyspepsia. Non-compliance as a result of these side-effects is a problem. Oral iron supplementation may also be insufficient to compensate for ongoing blood losses due to poor intestinal absorption. Parenteral iron was first introduced in the early 20th century in the form of intramuscular and subcutaneous injections. However, these early formulations caused severe toxic reactions leading to their disuse. Towards the latter half of the 20th century, high molecular weight iron dextran was introduced for both intravenous and intramuscular use. However, the use of high molecular weight iron dextran has been phased out and replaced with low molecular weight iron dextran and other newer formulations of intravenous iron such as iron sucrose, ferric gluconate, ferumoxytol, ferric carboxymaltose and iron isomaltoside. This was due to reports of anaphylactic-type reactions with the use of high molecular weight iron dextran due to the instability of the molecule as well as the formation of anti-dextran antibodies. Iron sucrose, a safer formulation not associated with anaphylactic-type reactions, had to be given in small maximum dosages of 200 mg for each infusion, thus requiring several small dose infusions to achieve the calculated iron deficit. Newer agents such as ferric carboxymaltose and iron isomaltoside have since been developed which allow total dose infusion and have much higher maximum approved doses and have not been associated with anaphylactic-type reactions.
    Actual start date of recruitment
    16 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 116
    Worldwide total number of subjects
    116
    EEA total number of subjects
    116
    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)
    21
    From 65 to 84 years
    83
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of patients who are awaiting surgery and have pre-operative anaemia as defined by a haemoglobin 1g/dL below the World Health Organisation threshold for normal haemoglobin (12g/dL for males and 11g/dL for females) would take place after the cancer diagnosis of histologically confirmed colorectal adenocarcinoma.

    Pre-assignment
    Screening details
    		 Patients were screened against the following inclusion criteria: able to consent, adult age >18 years, histologically proven colorectal adenocarcinoma, anaemic (male Hb <12 g/dL, female <11 g/dL), fit for surgery, date of surgery > 14 days from intervention.

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IV iron
    Arm description
    		 Intravenous ferric carboxymaltose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric carboxymaltose
    Investigational medicinal product code
    Other name
    Ferinject
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per SmPC

    Arm title
    		 Oral iron
    Arm description
    		 Oral ferrous sulphate
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ferrous sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg twice a day by mouth

    Number of subjects in period 1
    		IV iron Oral iron
    Started
    55
    61
    Completed
    55
    61
    Period 2
    Period 2 title
    Pre-operative
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IV iron
    Arm description
    		 Intravenous ferric carboxymaltose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric carboxymaltose
    Investigational medicinal product code
    Other name
    Ferinject
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per SmPC

    Arm title
    		 Oral iron
    Arm description
    		 Oral ferrous sulphate
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ferrous sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg twice a day by mouth

    Number of subjects in period 2
    		IV iron Oral iron
    Started
    55
    61
    Completed
    53
    57
    Not completed
    2
    4
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    -
    1
         Operation cancelled
    1
    3
    Period 3
    Period 3 title
    Post-operative
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IV iron
    Arm description
    		 Intravenous ferric carboxymaltose
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric carboxymaltose
    Investigational medicinal product code
    Other name
    Ferinject
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per SmPC

    Arm title
    		 Oral iron
    Arm description
    		 Oral ferrous sulphate
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ferric carboxymaltose
    Investigational medicinal product code
    Other name
    Ferinject
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    As per SmPC

    Investigational medicinal product name
    Ferrous sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg twice a day by mouth

    Number of subjects in period 3
    		IV iron Oral iron
    Started
    53
    57
    Completed
    53
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IV iron
    Reporting group description
    		 Intravenous ferric carboxymaltose

    Reporting group title
    Oral iron
    Reporting group description
    		 Oral ferrous sulphate

    Reporting group values
    		 IV iron Oral iron Total
    Number of subjects
    		 55 61 116
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 9 12 21
        From 65-84 years
    		 41 42 83
        85 years and over
    		 5 7 12
    Age continuous
    Units: years
        arithmetic mean (inter-quartile range (Q1-Q3))
    		 73.8 (67.4 to 78.6) 74.7 (67.9 to 80.8) -
    Gender categorical
    Units: Subjects
        Female
    		 20 24 44
        Male
    		 35 37 72
    Inclusion Hb
    Units: g/dL
        arithmetic mean (standard deviation)
    		 9.59 ± 1.44 9.91 ± 0.82 -

    End points

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    End points reporting groups
    Reporting group title
    IV iron
    Reporting group description
    		 Intravenous ferric carboxymaltose

    Reporting group title
    Oral iron
    Reporting group description
    		 Oral ferrous sulphate
    Reporting group title
    IV iron
    Reporting group description
    		 Intravenous ferric carboxymaltose

    Reporting group title
    Oral iron
    Reporting group description
    		 Oral ferrous sulphate
    Reporting group title
    IV iron
    Reporting group description
    		 Intravenous ferric carboxymaltose

    Reporting group title
    Oral iron
    Reporting group description
    		 Oral ferrous sulphate

    Primary: Mean volume of blood transfused DOS

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    End point title
    		 Mean volume of blood transfused DOS
    End point description
    End point type
    Primary
    End point timeframe
    Until end of day of surgery
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    53
    57
    Units: Units
        arithmetic mean (standard deviation)
    0.226 ± 0.72
    0.351 ± 1.3
    Statistical analysis title
    		 Students-T test
    Comparison groups
    Oral iron v IV iron
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.524 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - NS

    Primary: Mean volume of blood transfused Day 7

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    End point title
    		 Mean volume of blood transfused Day 7
    End point description
    End point type
    Primary
    End point timeframe
    Until end of post-op day 7
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [2]
    57
    Units: unit(s)
        arithmetic mean (standard deviation)
    0.157 ± 0.505
    0.597 ± 1.376
    Notes
    [2] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Students-T test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.027 [3]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - Significant

    Primary: Mean volume of blood transfused Day 14

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    End point title
    		 Mean volume of blood transfused Day 14
    End point description
    End point type
    Primary
    End point timeframe
    Until end of post-op day 14
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [4]
    57
    Units: unit(s)
        arithmetic mean (standard deviation)
    0.275 ± 0.964
    0.597 ± 1.376
    Notes
    [4] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Students-T test
    Comparison groups
    Oral iron v IV iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.158
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Mean volume of blood transfused Day 28

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    End point title
    		 Mean volume of blood transfused Day 28
    End point description
    End point type
    Primary
    End point timeframe
    Until end of post-op day 28
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [5]
    57
    Units: unit(s)
        arithmetic mean (standard deviation)
    0.294 ± 0.964
    0.632 ± 1.41
    Notes
    [5] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Students-T test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.146
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Mean volume of blood transfused OPD

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    End point title
    		 Mean volume of blood transfused OPD
    End point description
    End point type
    Primary
    End point timeframe
    Until out patients appointment
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [6]
    57
    Units: unit(s)
        arithmetic mean (standard deviation)
    0.412 ± 1.316
    0.632 ± 1.41
    Notes
    [6] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Students-T test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.404
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Number of patients transfused DOS

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    End point title
    		 Number of patients transfused DOS
    End point description
    End point type
    Primary
    End point timeframe
    Until end of day of surgery
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    53
    57
    Units: Patients
    7
    6
    Statistical analysis title
    		 Chi squared test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.876
    Method
    		 Chi-squared
    Confidence interval

    Primary: Number of patients transfused day 7

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    End point title
    		 Number of patients transfused day 7
    End point description
    End point type
    Primary
    End point timeframe
    Until end of day 7
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [7]
    57
    Units: Patients
    5
    14
    Notes
    [7] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Chi squared test
    Comparison groups
    Oral iron v IV iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.044 [8]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [8] - Significant

    Primary: Number of patients transfused day 14

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    End point title
    		 Number of patients transfused day 14
    End point description
    End point type
    Primary
    End point timeframe
    Until end of post op day 14
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [9]
    57
    Units: Patients
    6
    14
    Notes
    [9] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Chi squared test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.087
    Method
    		 Chi-squared
    Confidence interval

    Primary: Number of patients transfused day 28

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    End point title
    		 Number of patients transfused day 28
    End point description
    End point type
    Primary
    End point timeframe
    Until post op day 28
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [10]
    57
    Units: Patients
    7
    14
    Notes
    [10] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Chi squared test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.155
    Method
    		 Chi-squared
    Confidence interval

    Primary: Number of patients transfused OPD

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    End point title
    		 Number of patients transfused OPD
    End point description
    End point type
    Primary
    End point timeframe
    Until out patients appointment
    End point values
    		 IV iron Oral iron
    Number of subjects analysed
    51 [11]
    57
    Units: Patients
    8
    14
    Notes
    [11] - Two patients excluded with severe intra-operative blood loss
    Statistical analysis title
    		 Chi squared test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.253
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Haemoglobin

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    End point title
    		 Haemoglobin
    End point description
    End point type
    Secondary
    End point timeframe
    Day of surgery
    End point values
    		 IV iron Oral iron IV iron Oral iron
    Number of subjects analysed
    55
    61
    53
    57
    Units: g/dL
        arithmetic mean (inter-quartile range (Q1-Q3))
    10.2 (9.8 to 10.5)
    10.42 (10.1 to 10.7)
    11.9 (11.5 to 12.3)
    11 (10.6 to 11.4)
    Statistical analysis title
    		 Students-T test
    Statistical analysis description
    Comparison haemoglobin at baseline
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.24
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Students-T test
    Statistical analysis description
    Comparison haemoglobin pre-operatively
    Comparison groups
    Oral iron v IV iron
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.01
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Ferritin

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    End point title
    		 Ferritin
    End point description
    End point type
    Secondary
    End point timeframe
    Recruitment to day of surgery
    End point values
    		 IV iron Oral iron IV iron Oral iron
    Number of subjects analysed
    55
    61
    53
    57
    Units: microgram(s)/litre
        median (inter-quartile range (Q1-Q3))
    21 (8 to 46)
    26 (15 to 50)
    558 (329.8 to 1085.3)
    27.5 (17 to 51.5)
    Statistical analysis title
    		 Students-T test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.224
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Students-T test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Transferrin saturations

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    End point title
    		 Transferrin saturations
    End point description
    End point type
    Secondary
    End point timeframe
    Recruitment to day of surgery
    End point values
    		 IV iron Oral iron IV iron Oral iron
    Number of subjects analysed
    55
    61
    53
    57
    Units: percent
        median (inter-quartile range (Q1-Q3))
    7 (5 to 15)
    8 (6 to 20)
    19 (16 to 29)
    9 (5 to 14)
    Statistical analysis title
    		 Students-T test
    Comparison groups
    Oral iron v IV iron
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.038
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Students-T test
    Comparison groups
    IV iron v Oral iron
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The Nottingham University Hospitals Trust undertook an immediate review of reported SAEs for the study. All SAEs were to be reported to R&I within one working day of discovery or notification of the event.
    Adverse event reporting additional description
    AEs considered related to the study medication as judged by a medically qualified investigator or the sponsor were followed until resolution or the event was considered stable. All related AEs that resulted in a participant’s withdrawal from the studywere followed up until a satisfactory resolution occurred.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    IV iron
    Reporting group description
    		 Intravenous ferric carboxymaltose

    Reporting group title
    Oral iron
    Reporting group description
    		 Oral ferrous sulphate

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: See end of study report (summary attachment)
    Serious adverse events
    		 IV iron Oral iron
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 55 (18.18%)
    11 / 61 (18.03%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour progression
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic leak
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocutaneous fistula
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforation
    Additional description: Bowel perforation
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ileus
         subjects affected / exposed
    0 / 55 (0.00%)
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction
    Additional description: Bowel obstruction
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin and subcutaneous tissue disorders
    Rash
    Additional description: Rash and swelling
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (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
    Wound infection
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    Additional description: Surgical infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IV iron Oral iron
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 61 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2012
    (a) Value specified for definition of anaemia (b) Electrocardiogram assessment will not be performed. (c) Patients will be followed up at 6-12 weeks to coincide with routine clinical follow-up. (d) Addition of second quality of life questionnaire which will be retested at final review (e) IBC, IL-1 and IL-6 will no longer be measured (f) All females will have a pregnancy test (g) Hepcidin/erythropoietin level to be retested as part of planned blood tests at final review.
    09 Oct 2012
    -Addition of a new site (Derby) -Additional QoL Questionnaire (FACT-An)
    13 Mar 2013
    a) Addition of new site: St James University Hospitals Leeds b) Addition of new site: University Hospitals of Leicester NHS Trust c) Addition of new site: Yeovil District Hospital NHS Foundation Trust d) Addition of new site: University Hospitals Bristol Foundation NHS Trust e) Page 17 – Clarification that tumour specimen will only be collected at Nottingham site f) Page 25 -Clarification of pregnancy testing – only to be performed in females under 55 years of age or currently menstruating
    01 Nov 2013
    (a) Page 22 Age limit re-submitted for MHRA review. This was reviewed by ethics committee in amendment 4 but was erroneously not submitted to MHRA at that point. (b) Page 23 - Clarification that patients with confirmed liver and lung metastases will be excluded. (c) Page 29 - Patients who are lost to follow up or who fail to undergo surgery will still have data to review in line with an intention to treat basis. (d) Page 37 - Clarification of composition of the Trial Management Group
    12 Aug 2014
    New PI added to investigators
    06 May 2015
    (a) Correct version control of addition of PI as an investigator. (b) Page 16 - Addition of P selectin test

    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.
    See end of study report (summary attachment)
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