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    Clinical Trial Results:
    An open-label, multicentre, randomised, 2-arm study to investigate the comparative efficacy and safety of intravenous ferric carboxymaltose versus oral iron for the treatment of iron deficiency anaemia in pregnant women

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2009-017658-11
    Trial protocol
    		 DE   SE  
    Global end of trial date
    16 May 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    06 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FER-ASAP-2009-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01131624
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vifor Pharma
    Sponsor organisation address
    Flughofstrasse 61, Glattbrugg, Switzerland, CH-8152
    Public contact
    Medical Information, Vifor Pharma, +41 58 851 8222, medinfo@viforpharma.com
    Scientific contact
    Medical Information, Vifor Pharma, +41 58 851 8222, medinfo@viforpharma.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective • To evaluate the efficacy of ferric carboxymaltose (FCM) compared to oral iron in the treatment of iron deficiency anaemia (IDA) in pregnant women of the second and third trimester.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki, including amendments in force up to and including the time the study was conducted. The study was conducted in compliance with the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP), Committee for Proprietary Medicinal Products Guideline (CPMP/ICH/135/95), and compliant with the EU Clinical Trial Directive (Directive 2001/20/EC and 2005/28/EC). Before each subject was admitted to the study, a signed and dated informed consent was obtained from the subject (or his/her legally authorised representative) according to the regulatory and legal requirements of the participating country. This consent form was retained by the Investigator as part of the study records. A copy of the document was provided to the subject. No investigations specifically required for the study were conducted until valid consent was obtained. The content of the informed consent was in accordance with the current revision of the Declaration of Helsinki, current ICH and GCP guidelines, and Vifor Pharma - Vifor (International) Inc. policy. The Investigator explained the aims, methods, reasonably anticipated benefits and potential hazards of the study and any potential discomforts. Subjects were informed that their participation in the study was entirely voluntary and would have no effect on clinical care otherwise available and that they could withdraw consent to participate at any time without penalty or loss of further medical treatment. Subjects were told that Competent Authorities and authorised persons could examine their records but that personal information would be treated as strictly confidential and would not be publicly available. Revisions to the ICF made to reflect the changes to the protocol were reviewed and approved by the appropriate IEC, and signed by all subjects, both subsequently and/or previously enrolled in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2010
    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
    Sweden: 14
    Country: Number of subjects enrolled
    Switzerland: 9
    Country: Number of subjects enrolled
    Turkey: 4
    Country: Number of subjects enrolled
    Russian Federation: 124
    Country: Number of subjects enrolled
    Korea, Republic of: 90
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Australia: 8
    Worldwide total number of subjects
    252
    EEA total number of subjects
    14
    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)
    252
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were screened at 34 sites and randomised at 29 sites in 7 countries.

    Pre-assignment
    Screening details
    		 At total of 774 patients were screened and 252 randomized. Five randomized patients did not receive study drug.

    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
    		 Ferric carboxymaltose
    Arm description
    		 Subjects with body weight ≥66 kg received an infusion of 1,000 mg iron as ferric carboxymaltose (FCM) and after 1 week a further 500 mg iron as FCM, depending on haemoglobin (Hb) at screening. For subjects with body weight <66 kg, 2 to 3 infusions of 500 mg iron as FCM were administered within 2 weeks from baseline, depending on Hb at screening. Total doses of FCM were either 1,000 mg or 1,500 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferric carboxymaltose
    Investigational medicinal product code
    Other name
    Ferinject, FCM
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The maximum single dose of FCM that can be administered by intravenous infusion is 20 mL (1,000 mg iron) but should not exceed 15 mg of iron per kg of body weight. This means that for subjects with a body weight below 66 kg a maximal dose of 500 mg iron per infusion is allowed. The total required dose (1,000-1,500 mg) was administrated before Visit 3 (Day 21).

    Arm title
    		 Oral iron
    Arm description
    		 100 mg ferrous sulphate capsules taken twice a day for a total daily dose of 200 mg for up to 12 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oral iron
    Investigational medicinal product code
    Other name
    ferrous sulphate, Plastufer®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each capsule contained 100 mg iron and was taken twice per day for a total daily dose of 200 mg iron for up to 12 weeks. Generally oral iron should be taken between meals i.e., 2 hours before or 1 hour after a meal, for maximum absorption but could be taken with or after meals, if necessary, to minimise adverse GI effects.

    Number of subjects in period 1
    		Ferric carboxymaltose Oral iron
    Started
    126
    126
    Completed
    111
    110
    Not completed
    15
    16
         Consent withdrawn by subject
    8
    6
         Adverse event, non-fatal
    1
    7
         Lost to follow-up
    4
    2
         unspecified
    1
    -
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferric carboxymaltose
    Reporting group description
    		 Subjects with body weight ≥66 kg received an infusion of 1,000 mg iron as ferric carboxymaltose (FCM) and after 1 week a further 500 mg iron as FCM, depending on haemoglobin (Hb) at screening. For subjects with body weight <66 kg, 2 to 3 infusions of 500 mg iron as FCM were administered within 2 weeks from baseline, depending on Hb at screening. Total doses of FCM were either 1,000 mg or 1,500 mg.

    Reporting group title
    Oral iron
    Reporting group description
    		 100 mg ferrous sulphate capsules taken twice a day for a total daily dose of 200 mg for up to 12 weeks.

    Reporting group values
    		 Ferric carboxymaltose Oral iron Total
    Number of subjects
    		 126 126 252
    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)
    		 126 126 252
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.4 ( 5.77 ) 30.9 ( 5.39 ) -
    Gender categorical
    Units: Subjects
        Female
    		 126 126 252
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Ferric carboxymaltose
    Reporting group description
    		 Subjects with body weight ≥66 kg received an infusion of 1,000 mg iron as ferric carboxymaltose (FCM) and after 1 week a further 500 mg iron as FCM, depending on haemoglobin (Hb) at screening. For subjects with body weight <66 kg, 2 to 3 infusions of 500 mg iron as FCM were administered within 2 weeks from baseline, depending on Hb at screening. Total doses of FCM were either 1,000 mg or 1,500 mg.

    Reporting group title
    Oral iron
    Reporting group description
    		 100 mg ferrous sulphate capsules taken twice a day for a total daily dose of 200 mg for up to 12 weeks.

    Subject analysis set title
    Ferric carboxymaltose - Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects randomized to the FCM treatment arm who received at least 1 dose of randomised treatment and attended at least 1 post-baseline visit.

    Subject analysis set title
    Oral iron - Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects randomized to the oral iron treatment arm who received at least 1 dose of randomised treatment and attended at least 1 post-baseline visit.

    Subject analysis set title
    Ferric carboxymaltose - Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects randomized to the FCM treatment arm who received at least 1 dose of randomised treatment.

    Subject analysis set title
    Oral Iron - Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects randomized to the oral iron treatment arm who received at least 1 dose of randomized treatment.

    Primary: Change from Baseline to Week 3 in Haemoglobin

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    End point title
    		 Change from Baseline to Week 3 in Haemoglobin
    End point description
    Baseline was defined as the last non-missing value prior to dosing including Day 1.
    End point type
    Primary
    End point timeframe
    Day 0 (baseline), Week 3
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    114 [1]
    108 [2]
    Units: g/dL
        least squares mean (confidence interval 95%)
    1.14 (0.98 to 1.3)
    1.01 (0.85 to 1.18)
    Notes
    [1] - Full analysis set but restricted to those subjects that had a Week 3 visit.
    [2] - Full analysis set but restricted to those subjects that had a Week 3 visit.
    Statistical analysis title
    		 HB Change from Baseline
    Statistical analysis description
    Difference is calculated as FCM Hb level minus oral iron Hb levels. Thus a positive difference indicates a higher Hb level in the FCM arm.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.247 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Difference of Least-Squares-Means (LSM)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.109
    Notes
    [3] - The significance level is set at a 2-sided alpha of 0.05. ANCOVA includes factors for treatment, pooled country and Hb level at baseline.

    Secondary: Change from Baseline to Week 3, 6, 9, and 12 in Haemoglobin Using a Repeated Measures Model

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    End point title
    		 Change from Baseline to Week 3, 6, 9, and 12 in Haemoglobin Using a Repeated Measures Model
    End point description
    Baseline was defined as the last non-missing value prior to dosing including Day 1. Least-Squares-Means estimates were taken from the repeated measures model.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Weeks 3, 6, 9, 12
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121 [4]
    115 [5]
    Units: g/L
    least squares mean (confidence interval 95%)
        Week 3 (n=114, 108)
    1.16 (1 to 1.32)
    1.04 (0.88 to 1.21)
        Week 6 (n=109, 97)
    1.68 (1.5 to 1.87)
    1.4 (1.2 to 1.6)
        Week 9 (n=68, 61)
    2.07 (1.86 to 2.28)
    1.99 (1.77 to 2.21)
        Week 12 (n=34, 32)
    2.57 (2.2 to 2.94)
    2.15 (1.77 to 2.53)
    Notes
    [4] - # patients analyzed for each timepoint are reported within the category title.
    [5] - # patients analyzed for each timepoint are reported within the category title.
    Statistical analysis title
    		 Hb Change from Baseline: Week 3
    Statistical analysis description
    Difference is calculated as FCM Hb level minus oral iron Hb levels. Thus a positive difference indicates a higher Hb level in the FCM arm. Subjects in this analysis is 222.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.274 [6]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.109
    Notes
    [6] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Hb Change from Baseline: Week 6
    Statistical analysis description
    Difference is calculated as FCM Hb level minus oral iron Hb levels. Thus a positive difference indicates a higher Hb level in the FCM arm. Subjects in this analysis is 206.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.032 [7]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.132
    Notes
    [7] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Hb Change from Baseline: Week 9
    Statistical analysis description
    Difference is calculated as FCM Hb level minus oral iron Hb levels. Thus a positive difference indicates a higher Hb level in the FCM arm. Subjects in this analysis is 129.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.559 [8]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Notes
    [8] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Hb Change from Baseline: Week 12
    Statistical analysis description
    Difference is calculated as FCM Hb level minus oral iron Hb levels. Thus a positive difference indicates a higher Hb level in the FCM arm. Subjects in this analysis is 66.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.118 [9]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    0.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.265
    Notes
    [9] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Serum Ferritin

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    End point title
    		 Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Serum Ferritin
    End point description
    Baseline was defined as the last non-missing value prior to dosing including Day 1. Least-Squares-Means estimates were taken from the repeated measures model for weeks 3, 6, 9 and 12, and from a ANCOVA results model for the last visit prior to delivery.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Weeks 3, 6, 9, 12, last visit prior to delivery (longest is Week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121 [10]
    115 [11]
    Units: mcg/L
    least squares mean (confidence interval 95%)
        Week 3 (n=116, 110)
    301.81 (274.81 to 328.8)
    21.8 (-5.69 to 49.3)
        Week 6 (n=108, 100)
    110.64 (98 to 123.29)
    15.1 (2.33 to 27.87)
        Week 9 (n=69, 67)
    71.24 (56.46 to 86.02)
    23.23 (8.16 to 38.29)
        Week 12 (n=36, 33)
    46.4 (27.14 to 65.66)
    30.54 (10.08 to 50.99)
        Prior to delivery (n=104, 94)
    74.71 (60.27 to 89.15)
    23.93 (8.86 to 39)
    Notes
    [10] - # patients analyzed for each timepoint are reported within the category title.
    [11] - # patients analyzed for each timepoint are reported within the category title.
    Statistical analysis title
    		 Ferritin Change from Baseline: Week 3
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 226.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [12]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    280
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 241.91
         upper limit
    		 318.09
    Notes
    [12] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Ferritin Change from Baseline: Week 6
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 208.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [13]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    95.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 78.61
         upper limit
    		 112.48
    Notes
    [13] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Ferritin Change from Baseline: Week 9
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 136.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [14]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    48.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.76
         upper limit
    		 68.27
    Notes
    [14] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Ferritin Change from Baseline: Week 12
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 69.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.255 [15]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    15.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.73
         upper limit
    		 43.46
    Notes
    [15] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Ferritin Change from Baseline: Prior to delivery
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 198.
    Comparison groups
    Oral iron - Full analysis set v Ferric carboxymaltose - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [16]
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LSM
    Point estimate
    50.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 31.39
         upper limit
    		 70.17
    Notes
    [16] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Serum Iron

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    End point title
    		 Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Serum Iron
    End point description
    Baseline was defined as the last non-missing value prior to dosing including Day 1. Least-Squares-Means means estimates were taken from the repeated measures model for weeks 3, 6, 9 and 12, and from a ANCOVA results model for the last visit prior to delivery.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Weeks 3, 6, 9, 12, last visit prior to delivery (longest is Week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121 [17]
    115 [18]
    Units: μmol/L
    least squares mean (confidence interval 95%)
        Week 3 (n=117, 111)
    7.86 (5.87 to 9.86)
    11.63 (9.6 to 13.66)
        Week 6 (n=108, 100)
    6.85 (4.89 to 8.81)
    10.52 (8.52 to 12.53)
        Week 9 (n=69, 67)
    7.38 (4.79 to 9.98)
    10.79 (8.11 to 13.46)
        Week 12 (n=36, 33)
    4.75 (1.04 to 8.45)
    12.56 (8.63 to 16.48)
        Prior to delivery (n=104, 94)
    7.08 (4.97 to 9.19)
    12.73 (10.53 to 14.93)
    Notes
    [17] - # patients analyzed for each timepoint are reported within the category title.
    [18] - # patients analyzed for each timepoint are reported within the category title.
    Statistical analysis title
    		 Serum Iron Change from Baseline: Week 3
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 228.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [19]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -3.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 -1.03
    Notes
    [19] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Serum Iron Change from Baseline: Week 6
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 208.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008 [20]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -3.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.35
         upper limit
    		 -0.99
    Notes
    [20] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Serum Iron Change from Baseline: Week 9
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 136.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067 [21]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.05
         upper limit
    		 0.24
    Notes
    [21] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Serum Iron Change from Baseline: Week 12
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 69.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005 [22]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -7.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.16
         upper limit
    		 -2.46
    Notes
    [22] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Serum Iron Change from Baseline: Prior to Delivery
    Statistical analysis description
    Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 198.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [23]
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LSM
    Point estimate
    -5.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.48
         upper limit
    		 -2.83
    Notes
    [23] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Transferrin Saturation (TSAT)

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    End point title
    		 Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Transferrin Saturation (TSAT)
    End point description
    TSAT is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Of the transferrin that is available to bind iron, this value tells a clinician how much serum iron are actually bound. Baseline was defined as the last non-missing value prior to dosing including Day 1. Least-Squares-Means means estimates were taken from the repeated measures model for weeks 3, 6, 9 and 12, and from a ANCOVA results model for the last visit prior to delivery.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Weeks 3, 6, 9, 12, last visit prior to delivery (longest is Week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121 [24]
    115 [25]
    Units: percentage total iron-binding capacity
    least squares mean (confidence interval 95%)
        Week 3 (n=117, 111)
    13.65 (11.18 to 16.11)
    14.17 (11.69 to 16.66)
        Week 6 (n=108, 100)
    11.48 (9.02 to 13.94)
    13.06 (10.55 to 15.57)
        Week 9 (n=69, 67)
    10.64 (7.63 to 13.65)
    12.93 (9.82 to 16.03)
        Week 12 (n=36, 33)
    6.74 (2.28 to 11.2)
    16.12 (11.4 to 20.85)
        Prior to delivery (n=104, 94)
    10.51 (7.86 to 13.17)
    15.44 (12.68 to 18.2)
    Notes
    [24] - # patients analyzed for each timepoint are reported within the category title.
    [25] - # patients analyzed for each timepoint are reported within the category title.
    Statistical analysis title
    		 Transferrin Saturation: Week 3
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 228.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.758 [26]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.89
         upper limit
    		 2.84
    Notes
    [26] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Transferrin Saturation: Week 6
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 208.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.357 [27]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.95
         upper limit
    		 1.79
    Notes
    [27] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Transferrin Saturation: Week 9
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 136.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.287 [28]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -2.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.51
         upper limit
    		 1.94
    Notes
    [28] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Transferrin Saturation: Week 12
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 69.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005 [29]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -9.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.82
         upper limit
    		 -2.95
    Notes
    [29] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Transferrin Saturation: Prior to delivery
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 198.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007 [30]
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LSM
    Point estimate
    -4.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.48
         upper limit
    		 -1.38
    Notes
    [30] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Change from Baseline to Week 3, 6, 9 and 12 in Blood Reticulocyte Cell Haemoglobin Content

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    End point title
    		 Change from Baseline to Week 3, 6, 9 and 12 in Blood Reticulocyte Cell Haemoglobin Content
    End point description
    An analysis of haematological and iron parameter change from baseline. Baseline was defined as the last non-missing value prior to dosing including Day 1. Least-Squares-Means means estimates were taken from the repeated measures model.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Weeks 3, 6, 9, 12
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121 [31]
    115 [32]
    Units: pg
    least squares mean (confidence interval 95%)
        Week 3 (n=114, 108)
    3.92 (3.56 to 4.28)
    3.04 (2.67 to 3.41)
        Week 6 (n=109, 97)
    3.32 (2.97 to 3.68)
    3.07 (2.7 to 3.44)
        Week 9 (n=68, 62)
    2.99 (2.59 to 3.4)
    3.01 (2.59 to 3.43)
        Week 12 (n=34, 32)
    2.76 (1.97 to 3.56)
    2.86 (2.04 to 3.68)
    Notes
    [31] - # patients analyzed for each timepoint are reported within the category title.
    [32] - # patients analyzed for each timepoint are reported within the category title.
    Statistical analysis title
    		 Reticulocyte Cell Haemoglobin Content: Week 3
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 222.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [33]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference in LSM
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.37
    Notes
    [33] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Reticulocyte Cell Haemoglobin Content: Week 6
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 206.
    Comparison groups
    Oral iron - Full analysis set v Ferric carboxymaltose - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.312 [34]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference in LSM
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.73
    Notes
    [34] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Reticulocyte Cell Haemoglobin Content: Week 9
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 130.
    Comparison groups
    Oral iron - Full analysis set v Ferric carboxymaltose - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.968 [35]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference in LSM
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.57
         upper limit
    		 0.54
    Notes
    [35] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 Reticulocyte Cell Haemoglobin Content: Week 12
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 66.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.865 [36]
    Method
    		 Repeated measures model
    Parameter type
    		 Difference in LSM
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.22
         upper limit
    		 1.03
    Notes
    [36] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Soluble Transferrin Receptor (STR)

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    End point title
    		 Change from Baseline to Week 3, 6, 9, 12 and Last Visit Prior to Delivery in Soluble Transferrin Receptor (STR)
    End point description
    Baseline was defined as the last non-missing value prior to dosing including Day 1. Least-Squares-Means estimates were taken from the repeated measures model for weeks 3, 6, 9 and 12, and from a ANCOVA results model for the last visit prior to delivery.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Weeks 3, 6, 9, 12, last visit prior to delivery
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121 [37]
    115 [38]
    Units: mg/L
    least squares mean (confidence interval 95%)
        Week 3 (n=117, 111)
    -1.62 (-1.87 to -1.37)
    -1.43 (-1.68 to -1.18)
        Week 6 (n=108, 100)
    -2.36 (-2.6 to -2.12)
    -2.01 (-2.26 to -1.77)
        Week 9 (n=69, 68)
    -2.66 (-3.26 to -2.05)
    -1.64 (-2.28 to -1.01)
        Week 12 (36, 33)
    -2.21 (-4.3 to -0.11)
    -0.2 (-2.41 to 2.01)
        Prior to delivery (n=104, 94)
    -2.25 (-2.93 to -1.57)
    -1.6 (-2.31 to -0.9)
    Notes
    [37] - # patients analyzed for each timepoint are reported within the category title.
    [38] - # patients analyzed for each timepoint are reported within the category title.
    Statistical analysis title
    		 STR: Week 3
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 228.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.254 [39]
    Method
    		 Repeating measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 0.14
    Notes
    [39] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 STR: Week 6
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 208.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039 [40]
    Method
    		 Repeating measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 -0.02
    Notes
    [40] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 STR: Week 9
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 137.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.023 [41]
    Method
    		 Repeating measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 -0.14
    Notes
    [41] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 STR: Week 12
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 69.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.192 [42]
    Method
    		 Repeating measures model
    Parameter type
    		 Difference of LSM
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.05
         upper limit
    		 1.04
    Notes
    [42] - The significance level is set at a 2-sided alpha of 0.05.
    Statistical analysis title
    		 STR: Prior to delivery
    Statistical analysis description
    Values are change from baseline to timepoint. Difference is calculated as FCM parameter level minus oral iron parameter levels. Thus a positive difference indicates a higher parameter level in the FCM arm. Subjects in this analysis is 198.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161 [43]
    Method
    		 ANCOVA
    Parameter type
    		 Difference of LSM
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.55
         upper limit
    		 0.26
    Notes
    [43] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Percentage of Subjects Achieving Anaemia Correction

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    End point title
    		 Percentage of Subjects Achieving Anaemia Correction
    End point description
    Anaemia correction is used as a measure of treatment response and is defined as achievement of Hb ≥11.0 g/dL at any time before delivery. Any subject with an Hb level of ≥11.0 g/dL at baseline was regarded as a non-responder. For a subject without a baseline Hb level, no response was defined.
    End point type
    Secondary
    End point timeframe
    Day 0 to last visit prior to delivery (longest is Week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of total subjects
    number (not applicable)
        With anaemia correction
    83.5
    70.2
        Without anaemia correction
    16.5
    29.8
    Statistical analysis title
    		 Anaemia correction
    Statistical analysis description
    p-value is from a logistic regression model with fixed factors for treatment and pooled country and a covariate for baseline Hb level. The treatment odds ratio (OR) is the FCM odds divided by the oral iron odds.
    Comparison groups
    Oral iron - Full analysis set v Ferric carboxymaltose - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031 [44]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    2.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 3.97
    Notes
    [44] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Kaplan-Meier Estimate for Time to Anaemia Correction

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    End point title
    		 Kaplan-Meier Estimate for Time to Anaemia Correction
    End point description
    Subjects have their times censored at their last on study assessment considered for analysis if they have not corrected by that time. Subjects with a baseline Hb level of at least 11 g/dL or no post-baseline assessments are censored with a time to anaemia correction of day 1.
    End point type
    Secondary
    End point timeframe
    Day 0 to last visit prior to delivery (longest is Week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: weeks
        median (confidence interval 95%)
    3.4 (2.9 to 4.4)
    4.3 (3.4 to 5)
    Statistical analysis title
    		 Time to Anaemia Correction
    Statistical analysis description
    p-value based on an unstratified log-rank test.
    Comparison groups
    Ferric carboxymaltose - Full analysis set v Oral iron - Full analysis set
    Number of subjects included in analysis
    236
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11 [45]
    Method
    		 Logrank
    Confidence interval
    Notes
    [45] - The significance level is set at a 2-sided alpha of 0.05.

    Secondary: Change from Baseline to Week 3 in Health-Related Quality of Life (QoL) Using the 36-item Short-Form Health Survey (SF-36)

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    End point title
    		 Change from Baseline to Week 3 in Health-Related Quality of Life (QoL) Using the 36-item Short-Form Health Survey (SF-36)
    End point description
    SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The PCS has 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS also has 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on each subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores for each subscale are transformed into a range from 0 to 100; zero= worst HRQoL, 100=best HRQoL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. Positive change from baseline values represent improved HRQoL.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Week 3
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: units on a scale
    arithmetic mean (standard deviation)
        Physical Component Summary
    -0.61 ( 6.393 )
    -1.18 ( 6.873 )
        Physical functioning
    -2.37 ( 20.524 )
    -3.48 ( 21.201 )
        Role limits due to physical
    0.27 ( 23.147 )
    -2.57 ( 22.142 )
        Bodily pain
    -1.65 ( 22.221 )
    -3.04 ( 16.558 )
        General health perception
    2.07 ( 12 )
    1.21 ( 12.699 )
        Mental Component Summary
    2.18 ( 8.655 )
    1.34 ( 8.386 )
        Vitality
    6.3 ( 19.705 )
    3.96 ( 19.693 )
        Social Functioning
    3.5 ( 22.102 )
    0.56 ( 19.667 )
        Role limits due to emotional
    1.45 ( 23.186 )
    -1.08 ( 20.637 )
        Mental health
    1.65 ( 14.082 )
    1.79 ( 13.37 )
    No statistical analyses for this end point

    Secondary: Change from Baseline to Last Visit Before Delivery in Health-Related Quality of Life (HRQoL) Using the 36-item Short-Form Health Survey (SF-36)

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    End point title
    		 Change from Baseline to Last Visit Before Delivery in Health-Related Quality of Life (HRQoL) Using the 36-item Short-Form Health Survey (SF-36)
    End point description
    SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The PCS has 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS also has 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on each subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores for each subscale are transformed into a range from 0 to 100; zero= worst HRQoL, 100=best HRQoL. PCS and MCS scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score; higher scores indicate better health status. Positive change from baseline values represent improved HRQoL.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline), Last Visit Before Delivery (longest is Week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: units on a scale
    arithmetic mean (standard deviation)
        Physical Component Summary
    -2.74 ( 7.566 )
    -3.88 ( 7.905 )
        Physical functioning
    -9.42 ( 23.609 )
    -12.59 ( 22.036 )
        Role limits due to physical
    -5.66 ( 25.787 )
    -11.4 ( 25.909 )
        Bodily pain
    -3.21 ( 23.203 )
    -6.43 ( 24.096 )
        General health perception
    1.76 ( 13.114 )
    0.74 ( 12.674 )
        Mental Component Summary
    2.37 ( 9.059 )
    0.78 ( 9.758 )
        Vitality
    6.51 ( 21.897 )
    2.34 ( 22.089 )
        Social Functioning
    3.03 ( 23.613 )
    -2.5 ( 24.553 )
        Role limits due to emotional
    -1.68 ( 24.611 )
    -5.52 ( 26.82 )
        Mental health
    1.74 ( 15.312 )
    -0.13 ( 16.649 )
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at Baseline

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    End point title
    		 Patient Global Assessment at Baseline
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Day 0 (baseline)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    1.7
    0.9
        Score 2
    0.8
    1.7
        Score 3
    5.8
    2.6
        Score 4
    81.8
    89.6
        Score 5
    9.1
    3.5
        Score 6
    0
    0
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at Week 3

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    End point title
    		 Patient Global Assessment at Week 3
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Week 3
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    16.5
    12.2
        Score 2
    19.8
    18.3
        Score 3
    35.5
    31.3
        Score 4
    24.8
    34.8
        Score 5
    0
    0.9
        Score 6
    0.8
    0
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at Week 6

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    End point title
    		 Patient Global Assessment at Week 6
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    24
    17.4
        Score 2
    24.8
    23.5
        Score 3
    28.9
    30.4
        Score 4
    9.9
    14.8
        Score 5
    1.7
    0.9
        Score 6
    0
    0
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at Week 9

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    End point title
    		 Patient Global Assessment at Week 9
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Week 9
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    14
    17.4
        Score 2
    16.5
    17.4
        Score 3
    15.7
    16.5
        Score 4
    11.6
    6.1
        Score 5
    0
    0
        Score 6
    0
    0
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at Week 12

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    End point title
    		 Patient Global Assessment at Week 12
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    9.1
    8.7
        Score 2
    6.6
    11.3
        Score 3
    11.6
    3.5
        Score 4
    2.5
    2.6
        Score 5
    0
    1.7
        Score 6
    0
    0
    No statistical analyses for this end point

    Secondary: Patient Global Assessment at Last Visit Prior to Delivery

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    End point title
    		 Patient Global Assessment at Last Visit Prior to Delivery
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Last Visit Before Delivery (longest is week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    23.1
    24.3
        Score 2
    23.1
    19.1
        Score 3
    28.1
    26.1
        Score 4
    11.6
    8.7
        Score 5
    0.8
    2.6
        Score 6
    0
    0
    No statistical analyses for this end point

    Secondary: Patient Global Assessment Following Delivery

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    End point title
    		 Patient Global Assessment Following Delivery
    End point description
    Self-reported patient global assessment (PGA) was rated on a scale of 1-7: Score 1 = Has much improved, 2 = Has (moderately) improved, 3 = Has little improved, 4 = Is unchanged, 5 = Is a little worse, 6 = Is (moderately) worse, 7 = Is much worse. Percentage was calculated using the Full Analysis Set population as the denominator: FCM = 121 patients and Oral Iron = 115 patients. When fewer patients completed the global assessment at any timepoint, the sum of the percentages across the global assessment scores will be less than 100%.
    End point type
    Secondary
    End point timeframe
    Delivery (longest is week 25)
    End point values
    		 Ferric carboxymaltose - Full analysis set Oral iron - Full analysis set
    Number of subjects analysed
    121
    115
    Units: percentage of patients
    number (not applicable)
        Score 1
    0
    0.9
        Score 2
    1.7
    1.7
        Score 3
    0.8
    4.3
        Score 4
    0
    2.6
        Score 5
    0
    0
        Score 6
    0
    0
    No statistical analyses for this end point

    Secondary: Newborn Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Scores at 1 minute, 5 minutes and 10 minutes after Birth

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    End point title
    		 Newborn Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Scores at 1 minute, 5 minutes and 10 minutes after Birth
    End point description
    APGAR is a test performed by a healthcare professional at 1, 5 and 10 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5- and 10-minute scores assess how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant.
    End point type
    Secondary
    End point timeframe
    1-10 minutes after delivery (longest is week 25)
    End point values
    		 Ferric carboxymaltose Oral iron
    Number of subjects analysed
    112 [46]
    109 [47]
    Units: units on a scale
    arithmetic mean (standard deviation)
        One minute (n=43, 30)
    8.4 ( 0.85 )
    8.2 ( 1.27 )
        Five minutes (n=63, 73)
    9.2 ( 0.65 )
    9 ( 0.79 )
        Ten minutes (n=3, 3)
    10 ( 0 )
    10 ( 0 )
    Notes
    [46] - Subjects with information about newborns. # newborns are reported within the category line.
    [47] - Subjects with information about newborns. # newborns are reported within the category line.
    No statistical analyses for this end point

    Secondary: Newborn Birth Weight

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    End point title
    		 Newborn Birth Weight
    End point description
    End point type
    Secondary
    End point timeframe
    After delivery (longest is week 25)
    End point values
    		 Ferric carboxymaltose Oral iron
    Number of subjects analysed
    109 [48]
    106 [49]
    Units: kg
        arithmetic mean (standard deviation)
    3.401 ( 0.4975 )
    3.384 ( 0.5103 )
    Notes
    [48] - Newborns with assessments.
    [49] - Newborns with assessments.
    No statistical analyses for this end point

    Secondary: Newborn Cord Serum Ferritin

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    End point title
    		 Newborn Cord Serum Ferritin
    End point description
    End point type
    Secondary
    End point timeframe
    After delivery (longest is week 25)
    End point values
    		 Ferric carboxymaltose Oral iron
    Number of subjects analysed
    85 [50]
    67 [51]
    Units: mcg/L
        arithmetic mean (standard deviation)
    255.55 ( 187.189 )
    236.72 ( 135.927 )
    Notes
    [50] - # newborns with assessment
    [51] - # newborns with assessment
    No statistical analyses for this end point

    Secondary: Difference in Serum Ferritin Lab Values Between Mother and Newborn

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    End point title
    		 Difference in Serum Ferritin Lab Values Between Mother and Newborn
    End point description
    The difference between newborn and mother lab parameter levels were calculated as the mother’s assessment minus the newborn’s assessment.
    End point type
    Secondary
    End point timeframe
    After delivery (longest is week 25)
    End point values
    		 Ferric carboxymaltose Oral iron
    Number of subjects analysed
    83 [52]
    67 [53]
    Units: mcg/L
        arithmetic mean (standard deviation)
    -173.4 ( 195.017 )
    -195.15 ( 123.242 )
    Notes
    [52] - # mothers and their newborns with assessment
    [53] - # mothers and their newborns with assessment
    No statistical analyses for this end point

    Secondary: Participants with Treatment-Emergent Adverse Events (TEAE)

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    End point title
    		 Participants with Treatment-Emergent Adverse Events (TEAE)
    End point description
    An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the administration, at any dose, of a medicinal or therapeutic product whether or not considered related to that product. Relation to study drug was assessed by the investigator. Severity was rated by the investigator on a scale of 1 (mild) to 3 (severe - defined as incapacitating and the subject is unable to work or complete usual activity) Serious AEs include death (death due to progressive disease were not reported as an SAE), a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. AEs in the newborns are not considered treatment-emergent.
    End point type
    Secondary
    End point timeframe
    Day 0 (post treatment) up to 30 days after delivery (longest time is Week 29)
    End point values
    		 Ferric carboxymaltose - Safety set Oral Iron - Safety set
    Number of subjects analysed
    123
    124
    Units: participants
        Any TEAE
    60
    50
        Related TEAE
    14
    19
        Severe, related TEAE
    0
    1
        TEAE with outcome of death
    0
    0
        Serious TEAE
    23
    10
        Related, serious TEAE
    1
    0
        TEAE leading to discontinuation
    1
    7
        Related TEAE leading to discontinuation
    1
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 (post treatment) up to 30 days after delivery (longest time is Week 29)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Ferric carboxymaltose - Safety set
    Reporting group description
    		 Subjects randomized to the ferric carboxymaltose (FCM) treatment arm who received at least 1 dose of randomised treatment.

    Reporting group title
    Oral Iron - Safety set
    Reporting group description
    		 Subjects randomized to the oral iron treatment arm who received at least 1 dose of randomized treatment.

    Reporting group title
    Ferric carboxymaltose - Newborns
    Reporting group description
    		 Adverse events in the newborn of mothers who took ferric carboxymaltose. The reporting group is limited to subjects with information about newborns.

    Reporting group title
    Oral iron - Newborns
    Reporting group description
    		 Adverse events in the newborn of mothers who took oral iron. The reporting group is limited to subjects with information about newborns.

    Serious adverse events
    		 Ferric carboxymaltose - Safety set Oral Iron - Safety set Ferric carboxymaltose - Newborns Oral iron - Newborns
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 123 (18.70%)
    10 / 124 (8.06%)
    6 / 123 (4.88%)
    5 / 124 (4.03%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Congenital, familial and genetic disorders
    Congenital foot malformation
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Failed trial of labour
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal distress syndrome
    Additional description: Event was incorrectly assigned to mother rather than newborn.
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature delivery
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature rupture of membranes
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Threatened labour
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature labour
         subjects affected / exposed
    1 / 123 (0.81%)
    3 / 124 (2.42%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cephalo-pelvic disproportion
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (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
    Cervix dystocia
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (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
    Breech presentation
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Cervical incompetence
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Failed induction of labour
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    High risk pregnancy
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Uterine contractions during pregnancy
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Uterine hypotonus
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Pre-eclampsia
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature separation of placenta
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged labour
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prolonged rupture of membranes
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature baby
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    3 / 123 (2.44%)
    2 / 124 (1.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Vomiting
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal aspiration
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal asphyxia
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress syndrome
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental disorder
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Infections and infestations
    Amniotic cavity infection
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Pyelonephritis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Ferric carboxymaltose - Safety set Oral Iron - Safety set Ferric carboxymaltose - Newborns Oral iron - Newborns
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 123 (40.65%)
    46 / 124 (37.10%)
    10 / 123 (8.13%)
    6 / 124 (4.84%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign lymph node neoplasm
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences all number
    0
    0
    0
    1
    Anogenital warts
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vascular disorders
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences all number
    0
    0
    0
    1
    Flushing
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Varicose vein
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Meconium stain
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    3 / 123 (2.44%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Polyhydramnios
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences all number
    0
    1
    0
    1
    Umbilical cord abnormality
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Failed induction of labour
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foetal growth restriction
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gestational diabetes
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Intrapartum haemorrhage
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Large for dates baby
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oligohydramnios
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Placental insufficiency
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Postpartum haemorrhage
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Premature labour
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Premature rupture of membranes
         subjects affected / exposed
    3 / 123 (2.44%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Uterine contractions during pregnancy
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Uterine hypotonus
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Chills
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fatigue
         subjects affected / exposed
    4 / 123 (3.25%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Generalised oedema
         subjects affected / exposed
    1 / 123 (0.81%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Hyperthermia
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Local swelling
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    3 / 123 (2.44%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Suprapubic pain
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    3 / 123 (2.44%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    4 / 123 (3.25%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vaginal odour
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginal pain
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal flaring
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachypnoea
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences all number
    0
    0
    0
    1
    Use of accessory respiratory muscles
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    1 / 124 (0.81%)
         occurrences all number
    0
    0
    1
    1
    Cough
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    1 / 123 (0.81%)
    3 / 124 (2.42%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Nasal discharge discolouration
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Productive cough
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 123 (0.81%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Sleep disorder
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Amniotic fluid volume decreased
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastric pH decreased
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 123 (0.00%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lip injury
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Perineal injury
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Uterine cervical laceration
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    1 / 124 (0.81%)
         occurrences all number
    0
    0
    0
    1
    Single umbilical artery
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Bradycardia foetal
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 123 (8.13%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    10
    1
    0
    0
    Dizziness
         subjects affected / exposed
    5 / 123 (4.07%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    5
    2
    0
    0
    Dysgeusia
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Eye disorders
    Eye discharge
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 123 (5.69%)
    6 / 124 (4.84%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    8
    7
    0
    0
    Dyspepsia
         subjects affected / exposed
    1 / 123 (0.81%)
    8 / 124 (6.45%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    8
    0
    0
    Abdominal pain
         subjects affected / exposed
    3 / 123 (2.44%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    2 / 123 (1.63%)
    2 / 124 (1.61%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 123 (0.81%)
    6 / 124 (4.84%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    7
    0
    0
    Constipation
         subjects affected / exposed
    2 / 123 (1.63%)
    6 / 124 (4.84%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    7
    0
    0
    Diarrhoea
         subjects affected / exposed
    2 / 123 (1.63%)
    4 / 124 (3.23%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Gastritis
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Melaena
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 123 (1.63%)
    3 / 124 (2.42%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Skin discolouration
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    Pyelocaliectasis
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 124 (0.00%)
    1 / 123 (0.81%)
    0 / 124 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypothyroidism
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Back pain
         subjects affected / exposed
    3 / 123 (2.44%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Joint swelling
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ligament pain
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Candida infection
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cystitis
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tinea cruris
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 123 (3.25%)
    4 / 124 (3.23%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    7
    4
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 124 (0.00%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 124 (0.81%)
    0 / 123 (0.00%)
    0 / 124 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2011
    - Change of Inclusion Criterion 1 to allow inclusion of pregnant women from gestational Week 16 to Week 33 at baseline visit. - Change of Inclusion Criterion 2 to align inclusion Hb concentration for second and third trimester to align with Centers for Disease Control and Prevention guidelines. - Amended the statistical method for interim analysis. - Increased the number of sites from 25 to 40, and the site locations were changed from Germany, Saudi Arabia, Sweden, Switzerland and Turkey to Western Europe, Middle East, Asia Pacific and Russia. - Administrative changes to ensure consistency between protocol sections and synopsis, clarify the definition of previous iron therapy (Exclusion Criteria #1), clarify the required number of subjects for the interim analysis, and correct a calculation error in the document.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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