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    Clinical Trial Results:
    A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

    Summary
    EudraCT number
    		 2011-001866-17
    Trial protocol
    		 LV   PL  
    Global end of trial date
    23 Apr 2013

    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-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01114217
    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
    24 Sep 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and efficacy of ferumoxytol for the episodic 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
    27 Jul 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
    Canada: 48
    Country: Number of subjects enrolled
    India: 75
    Country: Number of subjects enrolled
    United States: 465
    Country: Number of subjects enrolled
    Hungary: 14
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Latvia: 24
    Worldwide total number of subjects
    634
    EEA total number of subjects
    46
    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)
    578
    From 65 to 84 years
    50
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants who previously enrolled in and completed AMAG-FER-IDA-301 [2011-001865-42], received any dose of study drug, and met the inclusion/exclusion criteria were eligible to enroll in this Extension Study AMAG-FER-IDA-303.

    Pre-assignment
    Screening details
    		 Participants enrolled in AMAG-FER-IDA-301, received any dose of study drug, completed study, and met the inclusion/exclusion criteria were eligible to enroll in Extension Study, AMAG-FER-IDA-303. Participants could be screened for eligibility and be enrolled in AMAG-FER-IDA-303 at the AMAG-FER-IDA-301 Week 5 visit or up to 2 weeks after that visit.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Received Ferumoxytol in IDA-303
    Arm description
    		 Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week Treatment Period (TP) and received a total of 2 doses of ferumoxytol 510 milligrams (mg) intravenously (IV). The first IV 510 mg dose was administered on TP Day 1 (Baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 grams (g).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ferumoxytol in IDA-303
    Investigational medicinal product code
    Other name
    Feraheme
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The first IV 510 mg dose was administered on TP Day 1 (Baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

    Arm title
    		 Did Not Receive Ferumoxytol in IDA-303
    Arm description
    		 Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42] and did not receive ferumoxytol during AMAG-FER-IDA-303.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Received Ferumoxytol in IDA-303 Did Not Receive Ferumoxytol in IDA-303
    Started
    337
    297
    Received at Least 1 Dose of Ferumoxytol
    337
    0 [1]
    Completed
    262
    199
    Not completed
    75
    98
         Other - Withdrawal by Subject
    1
    1
         Other - Lost to Follow-up
    1
    -
         Other - Clerical Error
    3
    -
         Other - Site stopped communicating
    2
    -
         Other - Physician Decision
    1
    1
         Consent withdrawn by subject
    21
    28
         Other - Protocol Violation
    1
    3
         Other - Lack of Efficacy
    1
    -
         Adverse event, non-fatal
    5
    3
         Other - Sponsor decision
    10
    12
         Other - Study Termination
    -
    1
         Other - Pregnancy
    2
    4
         Other - Early Termination
    6
    10
         Other - Procedure
    1
    1
         Lost to follow-up
    17
    33
         Other - Non-Compliance
    2
    -
         Other - Study Withdrawn
    1
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No investigational medicinal product was assigned in this arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Received Ferumoxytol in IDA-303
    Reporting group description
    		 Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week Treatment Period (TP) and received a total of 2 doses of ferumoxytol 510 milligrams (mg) intravenously (IV). The first IV 510 mg dose was administered on TP Day 1 (Baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 grams (g).

    Reporting group title
    Did Not Receive Ferumoxytol in IDA-303
    Reporting group description
    		 Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42] and did not receive ferumoxytol during AMAG-FER-IDA-303.

    Reporting group values
    		 Received Ferumoxytol in IDA-303 Did Not Receive Ferumoxytol in IDA-303 Total
    Number of subjects
    		 337 297 634
    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)
    		 304 274 578
        From 65-84 years
    		 29 21 50
        85 years and over
    		 4 2 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.0 ± 13.33 43.8 ± 13.26 -
    Gender categorical
    Units: Subjects
        Female
    		 304 269 573
        Male
    		 33 28 61

    End points

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    End points reporting groups
    Reporting group title
    Received Ferumoxytol in IDA-303
    Reporting group description
    		 Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week Treatment Period (TP) and received a total of 2 doses of ferumoxytol 510 milligrams (mg) intravenously (IV). The first IV 510 mg dose was administered on TP Day 1 (Baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 grams (g).

    Reporting group title
    Did Not Receive Ferumoxytol in IDA-303
    Reporting group description
    		 Participants who received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42] and did not receive ferumoxytol during AMAG-FER-IDA-303.

    Subject analysis set title
    Intent-To-Treat (ITT) Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who received at least 1 dose of ferumoxytol and had evaluable data for hemoglobin at TP Baseline and TP Week 5 in AMAG-FER-IDA-303.

    Primary: Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol

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    End point title
    		 Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol [1] [2]
    End point description
    Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) – Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1. Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit. Statistical analysis (t-test, 2-sided, with a p-value of <0.0001) was performed.
    End point type
    Primary
    End point timeframe
    TP Baseline (Day 1), TP Week 5
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    151 [3]
    Units: g/dL
        arithmetic mean (standard deviation)
    2.6 ± 1.55
    Notes
    [3] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course

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    End point title
    		 Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course [4]
    End point description
    Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as: Hemoglobin Change = Hemoglobin (TP Week 5) – Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
    End point type
    Secondary
    End point timeframe
    TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    337 [5]
    Units: g/dL
    arithmetic mean (standard deviation)
        Course 1, 151 Participants
    2.6 ± 1.55
        Course 2, 244 Participants
    1.5 ± 1.28
        Course 3, 69 Participants
    1.1 ± 1.30
    Notes
    [5] - ITT Population
    No statistical analyses for this end point

    Secondary: Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5

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    End point title
    		 Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5 [6]
    End point description
    Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
    End point type
    Secondary
    End point timeframe
    TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    337 [7]
    Units: Percentage of Participants
    number (not applicable)
        Course 1, 151 Participants
    78.8
        Course 2, 244 Participants
    43.9
        Course 3, 69 Participants
    37.7
    Notes
    [7] - ITT Population
    No statistical analyses for this end point

    Secondary: Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

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    End point title
    		 Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol [8]
    End point description
    Proportion of participants who achieved a hemoglobin level ≥12.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
    End point type
    Secondary
    End point timeframe
    TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    337 [9]
    Units: Percentage of Participants
    number (not applicable)
        Course 1, 151 Participants
    38.4
        Course 2, 244 Participants
    57.0
        Course 3, 69 Participants
    40.6
    Notes
    [9] - ITT Population
    No statistical analyses for this end point

    Secondary: Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

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    End point title
    		 Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol [10]
    End point description
    Mean change in TSAT from TP Baseline to TP Week 5 following each course of ferumoxytol.
    End point type
    Secondary
    End point timeframe
    TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    337 [11]
    Units: Percentage of Saturation
    arithmetic mean (standard deviation)
        Course 1, 151 Participants
    12.8 ± 10.19
        Course 2, 244 Participants
    11.7 ± 12.47
        Course 3, 69 Participants
    7.5 ± 9.13
    Notes
    [11] - ITT Population
    No statistical analyses for this end point

    Secondary: Participant-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

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    End point title
    		 Participant-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol [12]
    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 questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) – FACIT-Fatigue Score (Baseline). TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course. If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero.
    End point type
    Secondary
    End point timeframe
    TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    337 [13]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Course 1, 151 Participants
    6.9 ± 9.57
        Course 2, 244 Participants
    4.1 ± 8.58
        Course 3, 69 Participants
    1.5 ± 6.87
    Notes
    [13] - ITT Population
    No statistical analyses for this end point

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

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    End point title
    		 Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline [14]
    End point description
    Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered. Ranges were determined for 25%, 50%, and 75% of events. Course 3, 69 participants, is not reported due to the limitations of the EudraCT database, which requires actual numbers. The arithmetic mean for Course 3 was 30.7, with the inter-quartile (Q1-Q3) range of 22.0 to "not applicable" because there was an insufficient number of participants with events.
    End point type
    Secondary
    End point timeframe
    TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analyses for all efficacy endpoints were performed only on the Reporting Group receiving ferumoxytol.
    End point values
    		 Received Ferumoxytol in IDA-303
    Number of subjects analysed
    337 [15]
    Units: Days
    arithmetic mean (inter-quartile range (Q1-Q3))
        Course 1, 151 Participants
    27.8 (22.0 to 36.0)
        Course 2, 244 Participants
    30.6 (22.0 to 37.0)
    Notes
    [15] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Period Baseline (Day 1) through TP Week 5
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Received Ferumoxytol in IDA-303
    Reporting group description
    		 Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 [2011-001865-42]. Participants enrolled in AMAG-FER-IDA-303 who were found to have persistent or recurrent IDA, defined as hemoglobin <11.0 g/dL and TSAT <20% at any monthly evaluation visit (with the exception of the Study Termination visit), began a 5-week TP and received a total of 2 doses of ferumoxytol 510 mg IV. The first IV 510 mg dose was administered on TP Day 1 (Baseline) and second dose 2 to 8 (5±3) days after Dose 1, for a total cumulative dose of 1.02 g.

    Serious adverse events
    		 Received Ferumoxytol in IDA-303
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 337 (6.53%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer metastatic
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon cancer stage III
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 337 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stridor
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vocal cord disorder
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Postoperative fever
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 337 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Vocal cord paralysis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 337 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 337 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Small intestinal stenosis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 337 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Received Ferumoxytol in IDA-303
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 337 (27.60%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    4 / 337 (1.19%)
         occurrences all number
    9
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 337 (1.48%)
         occurrences all number
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 337 (3.26%)
         occurrences all number
    11
    Dysgeusia
         subjects affected / exposed
    4 / 337 (1.19%)
         occurrences all number
    7
    Headache
         subjects affected / exposed
    24 / 337 (7.12%)
         occurrences all number
    28
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 337 (2.67%)
         occurrences all number
    9
    Oedema peripheral
         subjects affected / exposed
    6 / 337 (1.78%)
         occurrences all number
    6
    Pyrexia
         subjects affected / exposed
    5 / 337 (1.48%)
         occurrences all number
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 337 (1.48%)
         occurrences all number
    6
    Constipation
         subjects affected / exposed
    7 / 337 (2.08%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    10 / 337 (2.97%)
         occurrences all number
    10
    Nausea
         subjects affected / exposed
    17 / 337 (5.04%)
         occurrences all number
    20
    Vomiting
         subjects affected / exposed
    10 / 337 (2.97%)
         occurrences all number
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 337 (2.08%)
         occurrences all number
    8
    Dyspnoea
         subjects affected / exposed
    4 / 337 (1.19%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 337 (1.78%)
         occurrences all number
    8
    Back pain
         subjects affected / exposed
    9 / 337 (2.67%)
         occurrences all number
    9
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 337 (2.97%)
         occurrences all number
    10
    Sinusitis
         subjects affected / exposed
    5 / 337 (1.48%)
         occurrences all number
    6
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 337 (1.78%)
         occurrences all number
    6
    Urinary tract infection
         subjects affected / exposed
    19 / 337 (5.64%)
         occurrences all number
    20
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    7 / 337 (2.08%)
         occurrences all number
    7

    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
    • Addition of optional cognitive function testing and exercise tolerance testing at United States sites for additional measures of clinical benefit outcomes following improvement in hemoglobin/anemia. • Addition of 2 new exploratory endpoints to account for the addition of the new clinical benefit outcomes assessments.

    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/26572233
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