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    Clinical Trial Results:
    A Phase III, Randomized, Open-label, Active-Controlled Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia

    Summary
    EudraCT number
    		 2010-018961-50
    Trial protocol
    		 LV   HU   FR   LT   DE   PL   GB   ES   IT  
    Global end of trial date
    09 Nov 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2018
    First version publication date
    21 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AMAG-FER-IDA-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01114204
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AMAG Pharmaceuticals, Inc.
    Sponsor organisation address
    1100 Winter Street, Waltham, United States, 02451
    Public contact
    Medical Information, AMAG Pharmaceuticals, Inc., +1 877-411-2510, amag@druginfo.com
    Scientific contact
    Medical Information, AMAG Pharmaceuticals, Inc., +1 877-411-2510, amag@druginfo.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
    09 Nov 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 62
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Germany: 15
    Country: Number of subjects enrolled
    Hungary: 95
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Latvia: 88
    Country: Number of subjects enrolled
    Lithuania: 90
    Country: Number of subjects enrolled
    Romania: 31
    Country: Number of subjects enrolled
    South Africa: 64
    Country: Number of subjects enrolled
    Ukraine: 100
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 46
    Worldwide total number of subjects
    605
    EEA total number of subjects
    386
    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)
    501
    From 65 to 84 years
    99
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was open to enrollment for adult participants with IDA, defined as hemoglobin <10.0 grams (g)/deciliter (dL) and transferrin saturation (TSAT) <20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.

    Pre-assignment
    Screening details
    		 Participants were screened for inclusion in this study up to 2 weeks (14 days) prior to the start of dosing with study drug (either ferumoxytol or iron sucrose).

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This is an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferumoxytol
    Arm description
    		 Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferumoxytol
    Investigational medicinal product code
    Other name
    Feraheme
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV injection of ferumoxytol, 510 mg (17 mL) at Baseline (Day 1) with a second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g

    Arm title
    		 Iron Sucrose
    Arm description
    		 Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Iron Sucrose
    Investigational medicinal product code
    Other name
    Venofer
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV injection or infusion of iron sucrose, 200 mg on Day 1 and at 4 other visits on non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g

    Number of subjects in period 1
    		Ferumoxytol Iron Sucrose
    Started
    406
    199
    Received at Least 1 Dose of Study Drug
    406
    199
    Completed
    385
    191
    Not completed
    21
    8
         Consent withdrawn by subject
    10
    6
         Other-Medical Monitor Request
    1
    -
         Adverse event, non-fatal
    3
    2
         Death
    1
    -
         Other-Participant Request
    2
    -
         Other-Personal Reasons
    2
    -
         Other-Protocol Violation
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.

    Reporting group values
    		 Ferumoxytol Iron Sucrose Total
    Number of subjects
    		 406 199 605
    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)
    		 338 163 501
        From 65-84 years
    		 64 35 99
        85 years and over
    		 4 1 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.0 ( 14.89 ) 48.9 ( 14.66 ) -
    Gender categorical
    Units: Subjects
        Female
    		 342 160 502
        Male
    		 64 39 103

    End points

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    End points reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.

    Subject analysis set title
    Intent-to-Treat (ITT) Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.

    Primary: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5

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    End point title
    		 Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
    End point description
    Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) through Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    406 [1]
    199 [2]
    Units: Count of Participants
        Up to Week 3
    291
    117
        Up to Week 4
    327
    145
        Up to Week 5
    341
    162
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analysed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
    Comparison groups
    Ferumoxytol v Iron Sucrose
    Number of subjects included in analysis
    605
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.2833 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment Difference
    Point estimate
    2.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.89
         upper limit
    		 9.06
    Variability estimate
    Standard deviation
    Notes
    [3] - The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.
    [4] - The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.

    Secondary: Mean Change In Hemoglobin From Baseline To Week 5

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    End point title
    		 Mean Change In Hemoglobin From Baseline To Week 5
    End point description
    Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) – Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    406 [5]
    199 [6]
    Units: g/dL
        arithmetic mean (standard deviation)
    2.9 ( 1.62 )
    2.7 ( 1.30 )
    Notes
    [5] - ITT Population
    [6] - ITT Population
    No statistical analyses for this end point

    Secondary: Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5

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    End point title
    		 Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
    End point description
    Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) – Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) through Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    406 [7]
    199 [8]
    Units: Count of Participants
        Up to Week 3
    123
    33
        Up to Week 4
    210
    67
        Up to Week 5
    271
    96
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change In TSAT From Baseline To Week 5

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    End point title
    		 Mean Change In TSAT From Baseline To Week 5
    End point description
    Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) – TSAT (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    406 [9]
    199 [10]
    Units: Percentage of saturation
        arithmetic mean (standard deviation)
    15.7 ( 16.80 )
    11.9 ( 14.41 )
    Notes
    [9] - ITT Population
    [10] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5

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    End point title
    		 Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
    End point description
    The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) – FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    399 [11]
    198 [12]
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    13.1 ( 11.78 )
    12.4 ( 11.22 )
    Notes
    [11] - ITT Population
    [12] - ITT Population
    No statistical analyses for this end point

    Secondary: Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline

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    End point title
    		 Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline
    End point description
    The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) up to Week 5
    End point values
    		 Ferumoxytol Iron Sucrose
    Number of subjects analysed
    406 [13]
    199 [14]
    Units: Days
        arithmetic mean (inter-quartile range (Q1-Q3))
    23.1 (15.0 to 24.0)
    25.2 (21.0 to 30.0)
    Notes
    [13] - ITT Population
    [14] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 (after study drug administration) to Week 5 (End of Treatment)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Ferumoxytol
    Reporting group description
    		 Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g.

    Reporting group title
    Iron Sucrose
    Reporting group description
    		 Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.

    Serious adverse events
    		 Ferumoxytol Iron Sucrose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 406 (4.19%)
    5 / 199 (2.51%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 406 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 406 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed [1]
    1 / 342 (0.29%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 406 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine haemorrhage
         subjects affected / exposed [2]
    2 / 342 (0.58%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 406 (0.25%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bartholin’s abscess
         subjects affected / exposed
    0 / 406 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 406 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viraemia
         subjects affected / exposed
    1 / 406 (0.25%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only female participants in both arms were exposed to this adverse event.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Only female participants in both arms were exposed to this adverse event.
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ferumoxytol Iron Sucrose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 406 (23.40%)
    69 / 199 (34.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 406 (0.99%)
    3 / 199 (1.51%)
         occurrences all number
    4
    3
    Hypotension
         subjects affected / exposed
    1 / 406 (0.25%)
    2 / 199 (1.01%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    9 / 406 (2.22%)
    2 / 199 (1.01%)
         occurrences all number
    10
    2
    Chills
         subjects affected / exposed
    0 / 406 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    0
    4
    Fatigue
         subjects affected / exposed
    3 / 406 (0.74%)
    2 / 199 (1.01%)
         occurrences all number
    3
    2
    Feeling hot
         subjects affected / exposed
    2 / 406 (0.49%)
    2 / 199 (1.01%)
         occurrences all number
    2
    2
    Injection site pain
         subjects affected / exposed
    0 / 406 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    3
    Oedema peripheral
         subjects affected / exposed
    3 / 406 (0.74%)
    2 / 199 (1.01%)
         occurrences all number
    3
    2
    Pyrexia
         subjects affected / exposed
    2 / 406 (0.49%)
    6 / 199 (3.02%)
         occurrences all number
    2
    6
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    2 / 406 (0.49%)
    2 / 199 (1.01%)
         occurrences all number
    2
    2
    Hypersensitivity
         subjects affected / exposed
    3 / 406 (0.74%)
    2 / 199 (1.01%)
         occurrences all number
    3
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed [3]
    3 / 342 (0.88%)
    3 / 160 (1.88%)
         occurrences all number
    3
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 406 (0.74%)
    4 / 199 (2.01%)
         occurrences all number
    3
    4
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 406 (0.99%)
    4 / 199 (2.01%)
         occurrences all number
    5
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 406 (0.74%)
    3 / 199 (1.51%)
         occurrences all number
    4
    4
    Blood urea decreased
         subjects affected / exposed
    2 / 406 (0.49%)
    2 / 199 (1.01%)
         occurrences all number
    2
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    3 / 406 (0.74%)
    2 / 199 (1.01%)
         occurrences all number
    3
    3
    Lymphocyte count decreased
         subjects affected / exposed
    4 / 406 (0.99%)
    2 / 199 (1.01%)
         occurrences all number
    5
    3
    White blood cell count decreased
         subjects affected / exposed
    3 / 406 (0.74%)
    3 / 199 (1.51%)
         occurrences all number
    3
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 406 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 406 (2.22%)
    3 / 199 (1.51%)
         occurrences all number
    12
    3
    Dysgeusia
         subjects affected / exposed
    9 / 406 (2.22%)
    13 / 199 (6.53%)
         occurrences all number
    9
    34
    Headache
         subjects affected / exposed
    19 / 406 (4.68%)
    11 / 199 (5.53%)
         occurrences all number
    25
    12
    Somnolence
         subjects affected / exposed
    0 / 406 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 406 (0.25%)
    2 / 199 (1.01%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 406 (0.49%)
    2 / 199 (1.01%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 406 (0.99%)
    3 / 199 (1.51%)
         occurrences all number
    4
    3
    Constipation
         subjects affected / exposed
    4 / 406 (0.99%)
    2 / 199 (1.01%)
         occurrences all number
    4
    2
    Dry mouth
         subjects affected / exposed
    6 / 406 (1.48%)
    0 / 199 (0.00%)
         occurrences all number
    6
    0
    Nausea
         subjects affected / exposed
    11 / 406 (2.71%)
    7 / 199 (3.52%)
         occurrences all number
    13
    8
    Vomiting
         subjects affected / exposed
    3 / 406 (0.74%)
    4 / 199 (2.01%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 406 (0.00%)
    4 / 199 (2.01%)
         occurrences all number
    0
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 406 (1.72%)
    1 / 199 (0.50%)
         occurrences all number
    8
    1
    Myalgia
         subjects affected / exposed
    5 / 406 (1.23%)
    0 / 199 (0.00%)
         occurrences all number
    6
    0
    Pain in extremity
         subjects affected / exposed
    1 / 406 (0.25%)
    2 / 199 (1.01%)
         occurrences all number
    1
    2
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 406 (0.25%)
    3 / 199 (1.51%)
         occurrences all number
    1
    3
    Influenza
         subjects affected / exposed
    4 / 406 (0.99%)
    2 / 199 (1.01%)
         occurrences all number
    4
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 406 (0.49%)
    2 / 199 (1.01%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 406 (0.49%)
    3 / 199 (1.51%)
         occurrences all number
    2
    3
    Notes
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Only female participants in both arms were exposed to this adverse event.

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27462400
    http://www.ncbi.nlm.nih.gov/pubmed/24639149
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