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    Clinical Trial Results:
    A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

    Summary
    EudraCT number
    		 2011-001865-42
    Trial protocol
    		 LV   HU   PL  
    Global end of trial date
    22 Oct 2012

    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-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01114139
    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
    22 Oct 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of a 1.02 grams (g) course of intravenous (IV) ferumoxytol, administered as 2 doses of 510 milligrams (mg) each, compared with placebo (normal saline) 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
    19 Jun 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
    Poland: 11
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Latvia: 27
    Country: Number of subjects enrolled
    Canada: 55
    Country: Number of subjects enrolled
    India: 112
    Country: Number of subjects enrolled
    United States: 587
    Worldwide total number of subjects
    808
    EEA total number of subjects
    54
    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)
    733
    From 65 to 84 years
    65
    85 years and over
    10

    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 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 placebo). Medical history was obtained, and clinical laboratory tests, a physical examination, and vital signs evaluations conducted to determine eligibility for inclusion in the study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This study was double-blinded with respect to treatment assignment administration of study drug and relevant laboratory parameters. All study participants, study staff (including the physician and all non-study individuals), with the exception of the test article administrator and the unblinded monitor, were blinded to the treatment assigned and administered to each participant.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ferumoxytol
    Arm description
    		 Participants received a total of 2 doses of IV ferumoxytol 510 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
    Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg of iron/mL, and mannitol, at a concentration of 44 mg/mL, in a black to reddish brown, sterile, aqueous, colloidal, isotonic solution. The product contains no preservatives. Intravenous injection of ferumoxytol, 510 mg (17 mL) at Baseline (Day 1) with a second dose 2 to 8 days after Dose 1, for a total cumulative dose of 1.02 g.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vials contained sterile saline from which 17 mL were drawn for injection. Intravenous injection of 17 mL of normal saline at Baseline (Day 1) with a second injection 2 to 8 days after the first.

    Number of subjects in period 1
    		Ferumoxytol Placebo
    Started
    608
    200
    Received at Least 1 Dose of Study Drug
    608
    200
    Completed
    569
    187
    Not completed
    39
    13
         Other-Out Of Window For Study Drug Dose
    1
    -
         Consent withdrawn by subject
    17
    6
         Other-Physician Changed Treatment
    1
    -
         Other-Participant Falsified Records
    -
    1
         Other-Participant Went On Hospice
    -
    1
         Adverse event, non-fatal
    3
    2
         Other-Protocol Violation
    1
    -
         Lost to follow-up
    15
    3
         Other-Missed 1 Visit
    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 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
    Placebo
    Reporting group description
    		 Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.

    Reporting group values
    		 Ferumoxytol Placebo Total
    Number of subjects
    		 608 200 808
    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)
    		 554 179 733
        From 65-84 years
    		 48 17 65
        85 years and over
    		 6 4 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ± 13.82 46.0 ± 13.58 -
    Gender categorical
    Units: Subjects
        Female
    		 542 178 720
        Male
    		 66 22 88

    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 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
    Placebo
    Reporting group description
    		 Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.

    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 placebo) 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 Placebo
    Number of subjects analysed
    608 [1]
    200 [2]
    Units: Number of Participants
    number (not applicable)
        Up to Week 2
    252
    5
        Up to Week 3
    386
    7
        Up to Week 4
    460
    8
        Up to Week 5
    493
    11
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 A ≥2.0 g/dL Increase In Hemoglobin
    Statistical analysis description
    Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
    Comparison groups
    Ferumoxytol v Placebo
    Number of subjects included in analysis
    808
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Treatment Difference
    Point estimate
    75.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 71.15
         upper limit
    		 80.02
    Notes
    [3] - Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. 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.
    [4] - The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.

    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 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. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 5
    End point values
    		 Ferumoxytol Placebo
    Number of subjects analysed
    608 [5]
    200 [6]
    Units: Mean
        number (not applicable)
    2.6
    0.1
    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 Placebo
    Number of subjects analysed
    608 [7]
    200 [8]
    Units: Count of Participants
        Up to Week 2
    33
    3
        Up to Week 3
    131
    5
        Up to Week 4
    240
    5
        Up to Week 5
    307
    6
    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). TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. 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 Placebo
    Number of subjects analysed
    608 [9]
    200 [10]
    Units: Mean (Standard Deviation)
        number (not applicable)
    11.4
    0.4
    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 Placebo
    Number of subjects analysed
    608 [11]
    200 [12]
    Units: Mean
        number (not applicable)
    11.7
    6.8
    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 A 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 A 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 Placebo
    Number of subjects analysed
    608 [13]
    200 [14]
    Units: Mean
        number (not applicable)
    23.5
    42.5
    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
    Screening Period (1-14 days before Day 1) through Week 5 (35 ± 2 days post Day 1)
    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
    Placebo
    Reporting group description
    		 Participants received a total of 2 doses of IV saline (17 mL). The first IV dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose.

    Serious adverse events
    		 Ferumoxytol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 608 (2.63%)
    6 / 200 (3.00%)
         number of deaths (all causes)
    2
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 608 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small intestine carcinoma
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    3 / 608 (0.49%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding
         subjects affected / exposed [1]
    0 / 542 (0.00%)
    1 / 178 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 608 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 608 (0.16%)
    3 / 200 (1.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    1 / 608 (0.16%)
    0 / 200 (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.
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ferumoxytol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    198 / 608 (32.57%)
    56 / 200 (28.00%)
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 608 (0.00%)
    3 / 200 (1.50%)
         occurrences all number
    0
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    9 / 608 (1.48%)
    0 / 200 (0.00%)
         occurrences all number
    10
    0
    Hypotension
         subjects affected / exposed
    8 / 608 (1.32%)
    1 / 200 (0.50%)
         occurrences all number
    8
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    24 / 608 (3.95%)
    7 / 200 (3.50%)
         occurrences all number
    28
    7
    Dysgeusia
         subjects affected / exposed
    9 / 608 (1.48%)
    1 / 200 (0.50%)
         occurrences all number
    10
    1
    Headache
         subjects affected / exposed
    35 / 608 (5.76%)
    12 / 200 (6.00%)
         occurrences all number
    41
    13
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    12 / 608 (1.97%)
    3 / 200 (1.50%)
         occurrences all number
    16
    3
    Oedema Peripheral
         subjects affected / exposed
    10 / 608 (1.64%)
    1 / 200 (0.50%)
         occurrences all number
    10
    1
    Pyrexia
         subjects affected / exposed
    7 / 608 (1.15%)
    1 / 200 (0.50%)
         occurrences all number
    9
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    11 / 608 (1.81%)
    5 / 200 (2.50%)
         occurrences all number
    11
    7
    Abdominal pain upper
         subjects affected / exposed
    7 / 608 (1.15%)
    1 / 200 (0.50%)
         occurrences all number
    7
    1
    Constipation
         subjects affected / exposed
    10 / 608 (1.64%)
    3 / 200 (1.50%)
         occurrences all number
    11
    4
    Diarrhoea
         subjects affected / exposed
    17 / 608 (2.80%)
    6 / 200 (3.00%)
         occurrences all number
    20
    6
    Nausea
         subjects affected / exposed
    28 / 608 (4.61%)
    5 / 200 (2.50%)
         occurrences all number
    32
    5
    Toothache
         subjects affected / exposed
    5 / 608 (0.82%)
    3 / 200 (1.50%)
         occurrences all number
    5
    4
    Vomiting
         subjects affected / exposed
    12 / 608 (1.97%)
    2 / 200 (1.00%)
         occurrences all number
    14
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 608 (1.15%)
    1 / 200 (0.50%)
         occurrences all number
    7
    1
    Dyspnoea
         subjects affected / exposed
    9 / 608 (1.48%)
    4 / 200 (2.00%)
         occurrences all number
    9
    7
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 608 (0.49%)
    3 / 200 (1.50%)
         occurrences all number
    3
    3
    Rash
         subjects affected / exposed
    12 / 608 (1.97%)
    0 / 200 (0.00%)
         occurrences all number
    12
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 608 (1.48%)
    5 / 200 (2.50%)
         occurrences all number
    11
    5
    Back pain
         subjects affected / exposed
    10 / 608 (1.64%)
    2 / 200 (1.00%)
         occurrences all number
    10
    2
    Muscle spasms
         subjects affected / exposed
    7 / 608 (1.15%)
    2 / 200 (1.00%)
         occurrences all number
    9
    2
    Pain in extremity
         subjects affected / exposed
    7 / 608 (1.15%)
    1 / 200 (0.50%)
         occurrences all number
    8
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    16 / 608 (2.63%)
    4 / 200 (2.00%)
         occurrences all number
    17
    4
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 608 (1.32%)
    2 / 200 (1.00%)
         occurrences all number
    8
    2
    Urinary Tract Infection
         subjects affected / exposed
    17 / 608 (2.80%)
    6 / 200 (3.00%)
         occurrences all number
    19
    7
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    9 / 608 (1.48%)
    0 / 200 (0.00%)
         occurrences all number
    9
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2011
    • A formal interim statistical analysis of efficacy data was not planned, but could be performed if requested by regulatory authorities. • For IV administration of the study drug, the use of a winged IV needle (also known as a “butterfly”) was prohibited. For participants in whom a portacath or peripherally inserted central catheter line was utilized for administration, initiation of an additional peripheral IV (such as a catheter, 18 gauge or larger when possible) was advisable. Intravenous fluid could be administered at a slow rate (such as <30 cubic centimeters/hour) to keep the line open. • Cognitive function testing and exercise tolerance testing were added to the study per the United States Food and Drug Agency's recommendation to include additional measures of clinical benefit outcomes following improvement in hemoglobin/anemia. • Addition of background information on the potential risks of performing a 6-minute walk test provided for Investigators to make informed decision regarding safety of the procedure. • To ensure participant safety and increase efficiency, Principle Investigators will be notified directly of any potentially concerning changes in hemoglobin.

    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/23983177
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