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    Clinical Trial Results:
    Gemtuzumab Ozogamicin (Mylotarg) Expanded Access Protocol for Treatment of Patients in the United States With Relapsed/Refractory Acute Myelogenous Leukemia Who May Benefit From Treatment and Have no Access to Other Comparable/Alternative Therapy.

    Summary
    EudraCT number
    2018-001321-68
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    04 Dec 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Jun 2018
    First version publication date
    15 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1761026
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02312037
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to allow compassionate access to Mylotarg for treatment of subjects with acute myeloid leukemia (AML) who were thought to have the potential to derive clinical benefit and who had exhausted other appropriate and reasonable treatment options including investigational studies.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 331
    Worldwide total number of subjects
    331
    EEA total number of subjects
    0
    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)
    11
    Children (2-11 years)
    62
    Adolescents (12-17 years)
    32
    Adults (18-64 years)
    117
    From 65 to 84 years
    103
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 331 subjects were enrolled in multiple sites of United States from 27 Dec 2014 to 04 Dec 2017

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Mylotarg: Monotherapy
    Arm description
    Subjects received a single dose of Mylotarg less than or equal to (<=) 9 milligram per meter square (mg/m^2), intravenous (IV) infusion on Day 1 and Day 15 for a 28-day treatment cycle (up to a maximum of 2 cycles). Alternate treatment regimens tested in clinical trial settings and reported in peer reviewed journals were also permitted where published results demonstrated that the regimen was tolerated and effective. The subjects were followed up to 60 days after the last dose of the study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Mylotarg
    Investigational medicinal product code
    Other name
    Gemtuzumab ozogamicin
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a single dose of Mylotarg <=9 milligram per meter square (mg/m^2), intravenous (IV) infusion on Day 1 and Day 15 for a 28-day treatment cycle (up to a maximum of 2 cycles). Alternate treatment regimens tested in clinical trial settings and reported in peer reviewed journals were also permitted where published results demonstrated that the regimen was tolerated and effective.

    Arm title
    Mylotarg with Standard Chemotherapy
    Arm description
    Subjects received Mylotarg <=9 mg/m^2 in split doses over 8 days (Days 1, 4 and 7), with no single dose more than (>) 3 mg/m^2 (maximum, 5 mg per dose) in combination with standard anthracycline and/or cytarabine (AraC), according to the standard of treatment care. The subjects were followed up 60 days after the last dose of the study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Mylotarg
    Investigational medicinal product code
    Other name
    Gemtuzumab ozogamicin
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Mylotarg <=9 mg/m^2 in split doses over 8 days (Days 1, 4 and 7), with no single dose >3 mg/m^2 (maximum, 5 mg per dose).

    Investigational medicinal product name
    Anthracycline/Ara-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received standard anthracycline and/or AraC, according to the standard of treatment care.

    Arm title
    Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Arm description
    Subjects received Mylotarg <=9 mg/m^2 on Day 1 and Day 15 for 28-day treatment cycle (up to 2 cycles in absence of a complete remission,) either as a monotherapy or in tested combinations with all-trans retinoic acid (ATRA) and/or arsenic trioxide. The subjects were followed up 60 days after the last dose of the study drug.
    Arm type
    Experimental

    Investigational medicinal product name
    Mylotarg, Standard Chemotherapy
    Investigational medicinal product code
    Other name
    Gemtuzumab ozogamicin
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Mylotarg <=9 mg/m^2 on Day 1 and Day 15 for 28-day treatment cycle (up to 2 cycles in absence of a complete remission,) either as a monotherapy or in tested combinations with all-trans retinoic acid (ATRA) and/or arsenic trioxide, according to the standard of treatment care.

    Number of subjects in period 1
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Started
    139
    183
    9
    Completed
    45
    112
    6
    Not completed
    94
    71
    3
         Subject refused further follow up
    5
    1
    -
         Study terminated by sponsor
    -
    1
    -
         Unspecified
    28
    31
    1
         Subject Died
    60
    38
    2
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mylotarg: Monotherapy
    Reporting group description
    Subjects received a single dose of Mylotarg less than or equal to (<=) 9 milligram per meter square (mg/m^2), intravenous (IV) infusion on Day 1 and Day 15 for a 28-day treatment cycle (up to a maximum of 2 cycles). Alternate treatment regimens tested in clinical trial settings and reported in peer reviewed journals were also permitted where published results demonstrated that the regimen was tolerated and effective. The subjects were followed up to 60 days after the last dose of the study drug.

    Reporting group title
    Mylotarg with Standard Chemotherapy
    Reporting group description
    Subjects received Mylotarg <=9 mg/m^2 in split doses over 8 days (Days 1, 4 and 7), with no single dose more than (>) 3 mg/m^2 (maximum, 5 mg per dose) in combination with standard anthracycline and/or cytarabine (AraC), according to the standard of treatment care. The subjects were followed up 60 days after the last dose of the study drug.

    Reporting group title
    Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Reporting group description
    Subjects received Mylotarg <=9 mg/m^2 on Day 1 and Day 15 for 28-day treatment cycle (up to 2 cycles in absence of a complete remission,) either as a monotherapy or in tested combinations with all-trans retinoic acid (ATRA) and/or arsenic trioxide. The subjects were followed up 60 days after the last dose of the study drug.

    Reporting group values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia Total
    Number of subjects
    139 183 9 331
    Age Categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    2 9 0 11
        Children (2-11 years)
    13 49 0 62
        Adolescents (12-17 years)
    6 26 0 32
        Adults (18-64 years)
    47 64 6 117
        From 65-84 years
    66 35 2 103
        85 years and over
    5 0 1 6
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    54.6 ± 25.0 32.1 ± 26.7 56.7 ± 19.1 -
    Gender Categorical
    Units: Subjects
        Female
    60 86 1 147
        Male
    79 97 8 184
    Race/Ethnicity, Customized
    Units: Subjects
        White
    121 142 7 270
        Black
    10 14 1 25
        Asian
    2 8 0 10
        Other
    6 19 1 26

    End points

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    End points reporting groups
    Reporting group title
    Mylotarg: Monotherapy
    Reporting group description
    Subjects received a single dose of Mylotarg less than or equal to (<=) 9 milligram per meter square (mg/m^2), intravenous (IV) infusion on Day 1 and Day 15 for a 28-day treatment cycle (up to a maximum of 2 cycles). Alternate treatment regimens tested in clinical trial settings and reported in peer reviewed journals were also permitted where published results demonstrated that the regimen was tolerated and effective. The subjects were followed up to 60 days after the last dose of the study drug.

    Reporting group title
    Mylotarg with Standard Chemotherapy
    Reporting group description
    Subjects received Mylotarg <=9 mg/m^2 in split doses over 8 days (Days 1, 4 and 7), with no single dose more than (>) 3 mg/m^2 (maximum, 5 mg per dose) in combination with standard anthracycline and/or cytarabine (AraC), according to the standard of treatment care. The subjects were followed up 60 days after the last dose of the study drug.

    Reporting group title
    Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Reporting group description
    Subjects received Mylotarg <=9 mg/m^2 on Day 1 and Day 15 for 28-day treatment cycle (up to 2 cycles in absence of a complete remission,) either as a monotherapy or in tested combinations with all-trans retinoic acid (ATRA) and/or arsenic trioxide. The subjects were followed up 60 days after the last dose of the study drug.

    Primary: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between the first dose of study drug and up to 60 days after the last dose, which initiated after the treatment or worsened during the treatment period. AEs included both serious and non-serious adverse events. Safety analysis set included all subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
        AEs
    134
    172
    9
        SAEs
    101
    86
    6
    No statistical analyses for this end point

    Primary: Number of Subjects With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [2]
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between the first dose of study drug and up to 60 days after the last dose, which initiated after the treatment or worsened during the treatment period. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a subject who received study drug. AEs included both serious and non-serious adverse events. Safety analysis set included all subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    Notes
    [2] - 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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
        AEs
    84
    102
    7
        SAEs
    29
    39
    4
    No statistical analyses for this end point

    Primary: Number of Subjects With Treatment-Emergent Adverse Events of Grade 3 or 4 Severity

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events of Grade 3 or 4 Severity [3]
    End point description
    An AE was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe (unacceptable or intolerable events), Grade 4= life threatening AEs and Grade 5= death related to AE. Treatment-emergent were events between the first dose of study drug and up to 60 days after the last dose, which initiated after the treatment or worsened during the treatment period. AEs included both serious and non-serious adverse events. Safety analysis set included all enrolled subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    Notes
    [3] - 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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
    122
    168
    8
    No statistical analyses for this end point

    Primary: Number of Subjects With Treatment Related Treatment-Emergent Adverse Events of Grade 3 or 4 Severity

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    End point title
    Number of Subjects With Treatment Related Treatment-Emergent Adverse Events of Grade 3 or 4 Severity [4]
    End point description
    An AE was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe (unacceptable or intolerable events), Grade 4= life threatening AEs and Grade 5= death related to AE. Treatment-emergent were events between the first dose of study drug and up to 60 days after the last dose, which initiated after the treatment or worsened during the treatment period. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a subject who received study drug. AEs included both serious and non-serious adverse events. Safety analysis set included all enrolled subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    Notes
    [4] - 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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
    83
    101
    7
    No statistical analyses for this end point

    Primary: Number of Subjects With Treatment-Emergent Adverse Events of Grade 5 Severity

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events of Grade 5 Severity [5]
    End point description
    An AE was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe (unacceptable or intolerable events), Grade 4= life threatening AEs and Grade 5= death related to AE. Treatment-emergent were events between the first dose of study drug and up to 60 days after the last dose, which initiated after the treatment or worsened during the treatment period. AEs included both serious and non-serious adverse events. Safety analysis set included all enrolled subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    Notes
    [5] - 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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
    72
    40
    2
    No statistical analyses for this end point

    Primary: Number of Subjects With Treatment Related Treatment-Emergent Adverse Events of Grade 5 Severity

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    End point title
    Number of Subjects With Treatment Related Treatment-Emergent Adverse Events of Grade 5 Severity [6]
    End point description
    An AE was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe (unacceptable or intolerable events), Grade 4= life threatening AEs and Grade 5= death related to AE. Treatment-emergent were events between the first dose of study drug and up to 60 days after the last dose, which initiated after the treatment or worsened during the treatment period. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a subject who received study drug. AEs included both serious and non-serious adverse events. Safety analysis set included all enrolled subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    Notes
    [6] - 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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
    6
    9
    0
    No statistical analyses for this end point

    Primary: Number of Subjects Who Discontinued the Study Treatment Due to Adverse Events

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    End point title
    Number of Subjects Who Discontinued the Study Treatment Due to Adverse Events [7]
    End point description
    An AE was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. Safety analysis set included all enrolled subjects who received at least 1 dose of Mylotarg.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 60 days after the last dose
    Notes
    [7] - 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: Only descriptive data was planned to be analyzed for this endpoint. It is applicable for all the primary endpoints
    End point values
    Mylotarg: Monotherapy Mylotarg with Standard Chemotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Number of subjects analysed
    139
    183
    9
    Units: subjects
    25
    11
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Day 1) up to 60 days after the last dose
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Mylotarg: Monotherapy
    Reporting group description
    Subjects received a single dose of Mylotarg less than or equal to (<=) 9 milligram per meter square (mg/m^2), intravenous (IV) infusion on Day 1 and Day 15 for a 28-day treatment cycle (up to a maximum of 2 cycles). Alternate treatment regimens tested in clinical trial settings and reported in peer reviewed journals were also permitted where published results demonstrated that the regimen was tolerated and effective. The subjects were followed up to 60 days after the last dose of the study drug.

    Reporting group title
    Mylotarg: Treatment for Acute Promyelocytic Leukemia
    Reporting group description
    Subjects received Mylotarg <=9 mg/m^2 on Day 1 and Day 15 for 28-day treatment cycle (up to 2 cycles in absence of a complete remission,) either as a monotherapy or in tested combinations with all-trans retinoic acid (ATRA) and/or arsenic trioxide. The subjects were followed up 60 days after the last dose of the study drug.

    Reporting group title
    Mylotarg with Standard Chemotherapy
    Reporting group description
    Subjects received Mylotarg <=9 mg/m^2 in split doses over 8 days (Days 1, 4 and 7), with no single dose more than (>) 3 mg/m^2 (maximum, 5 mg per dose) in combination with standard anthracycline and/or cytarabine (AraC), according to the standard of treatment care. The subjects were followed up 60 days after the last dose of the study drug.

    Serious adverse events
    Mylotarg: Monotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia Mylotarg with Standard Chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    101 / 139 (72.66%)
    6 / 9 (66.67%)
    86 / 183 (46.99%)
         number of deaths (all causes)
    49
    2
    36
         number of deaths resulting from adverse events
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venoocclusive disease
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    17 / 139 (12.23%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    Chloroma
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytokine release syndrome
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    32 / 139 (23.02%)
    1 / 9 (11.11%)
    14 / 183 (7.65%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 1
    0 / 14
         deaths causally related to treatment / all
    1 / 19
    0 / 0
    0 / 2
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    5 / 183 (2.73%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    2 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    1 / 2
    Sudden death
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Transfusion reaction
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Urine output decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    3 / 139 (2.16%)
    1 / 9 (11.11%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    Cardiac failure
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    Pulmonary oedema
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Respiratory distress
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Respiratory failure
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    8 / 183 (4.37%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    2 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    1 / 5
    Stridor
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    Febrile neutropenia
         subjects affected / exposed
    15 / 139 (10.79%)
    4 / 9 (44.44%)
    12 / 183 (6.56%)
         occurrences causally related to treatment / all
    14 / 15
    5 / 5
    12 / 13
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 9 (11.11%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
    Occipital neuralgia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn’s disease
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Venoocclusive liver disease
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Device related infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fungal infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Liver abscess
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Meningitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    5 / 139 (3.60%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    9 / 139 (6.47%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    6 / 10
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    5 / 7
    0 / 0
    1 / 2
    Septic shock
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection viral
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viraemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Mylotarg: Monotherapy Mylotarg: Treatment for Acute Promyelocytic Leukemia Mylotarg with Standard Chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    114 / 139 (82.01%)
    5 / 9 (55.56%)
    159 / 183 (86.89%)
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Hypertension
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    10 / 183 (5.46%)
         occurrences all number
    3
    0
    11
    Hypotension
         subjects affected / exposed
    6 / 139 (4.32%)
    0 / 9 (0.00%)
    9 / 183 (4.92%)
         occurrences all number
    7
    0
    9
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Chloroma
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Infected neoplasm
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Tumour pain
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Serum sickness
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Chills
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Device related thrombosis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Disease progression
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Face oedema
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    8 / 139 (5.76%)
    0 / 9 (0.00%)
    7 / 183 (3.83%)
         occurrences all number
    8
    0
    8
    Mucosal inflammation
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    1
    0
    3
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Oedema
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    5 / 183 (2.73%)
         occurrences all number
    1
    0
    5
    Pyrexia
         subjects affected / exposed
    5 / 139 (3.60%)
    0 / 9 (0.00%)
    10 / 183 (5.46%)
         occurrences all number
    5
    0
    12
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Delirium
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    2
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Menorrhagia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Vulvovaginal inflammation
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Infusion related reaction
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    4
    0
    3
    Radiation skin injury
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 139 (5.04%)
    1 / 9 (11.11%)
    15 / 183 (8.20%)
         occurrences all number
    7
    1
    17
    Amylase increased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    2
    0
    0
    Aspartate aminotransferase
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 139 (7.19%)
    1 / 9 (11.11%)
    17 / 183 (9.29%)
         occurrences all number
    14
    1
    18
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Blood bilirubin increased
         subjects affected / exposed
    7 / 139 (5.04%)
    1 / 9 (11.11%)
    3 / 183 (1.64%)
         occurrences all number
    9
    1
    3
    Blood creatinine increased
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    3
    0
    3
    Blood fibrinogen decreased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    4
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    0
    0
    3
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Fungal test positive
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    2
    0
    7
    Granulocyte count decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    2
    Haemoglobin decreased
         subjects affected / exposed
    8 / 139 (5.76%)
    0 / 9 (0.00%)
    4 / 183 (2.19%)
         occurrences all number
    34
    0
    13
    Lipase
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    0
    0
    5
    Lymphocyte count decreased
         subjects affected / exposed
    29 / 139 (20.86%)
    0 / 9 (0.00%)
    52 / 183 (28.42%)
         occurrences all number
    42
    0
    137
    Neutrophil count abnormal
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    20 / 139 (14.39%)
    2 / 9 (22.22%)
    57 / 183 (31.15%)
         occurrences all number
    28
    3
    124
    Platelet count
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    12
    0
    0
    Platelet count decreased
         subjects affected / exposed
    49 / 139 (35.25%)
    3 / 9 (33.33%)
    64 / 183 (34.97%)
         occurrences all number
    229
    8
    361
    Streptococcus test positive
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Urine output decreased
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    52 / 139 (37.41%)
    1 / 9 (11.11%)
    66 / 183 (36.07%)
         occurrences all number
    123
    6
    146
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Atrial fibrillation
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Cardiac failure
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    0
    0
    3
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    3
    Left ventricular failure
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Ventricular tachycardia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Acute respiratory failure
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Aspiration
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Atelectasis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspnoea
         subjects affected / exposed
    6 / 139 (4.32%)
    0 / 9 (0.00%)
    8 / 183 (4.37%)
         occurrences all number
    6
    0
    9
    Epistaxis
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    5 / 183 (2.73%)
         occurrences all number
    4
    0
    9
    Hypoxia
         subjects affected / exposed
    8 / 139 (5.76%)
    1 / 9 (11.11%)
    15 / 183 (8.20%)
         occurrences all number
    9
    1
    18
    Nasal congestion
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngeal haemorrhage
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    3
    0
    3
    Pleuritic pain
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Pneumonitis
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    2
    0
    0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    4 / 183 (2.19%)
         occurrences all number
    4
    0
    4
    Respiratory disorder
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory distress
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory failure
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    2
    0
    1
    Stridor
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Tachypnoea
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    54 / 139 (38.85%)
    2 / 9 (22.22%)
    86 / 183 (46.99%)
         occurrences all number
    112
    4
    198
    Coagulopathy
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Febrile neutropenia
         subjects affected / exposed
    30 / 139 (21.58%)
    3 / 9 (33.33%)
    60 / 183 (32.79%)
         occurrences all number
    40
    3
    90
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    3
    0
    2
    Leukopenia
         subjects affected / exposed
    9 / 139 (6.47%)
    0 / 9 (0.00%)
    19 / 183 (10.38%)
         occurrences all number
    15
    0
    23
    Lymphopenia
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    3
    0
    5
    Neutropenia
         subjects affected / exposed
    12 / 139 (8.63%)
    0 / 9 (0.00%)
    14 / 183 (7.65%)
         occurrences all number
    24
    0
    20
    Pancytopenia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    16 / 139 (11.51%)
    0 / 9 (0.00%)
    19 / 183 (10.38%)
         occurrences all number
    31
    0
    25
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Encephalopathy
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Headache
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    1
    0
    3
    Hydrocephalus
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Idiopathic intracranial hypertension
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Paraplegia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    2
    0
    1
    Tremor
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 9 (11.11%)
    8 / 183 (4.37%)
         occurrences all number
    1
    1
    9
    Abdominal pain upper
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Colitis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Constipation
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    5 / 183 (2.73%)
         occurrences all number
    0
    0
    5
    Dysphagia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    2
    Enterocolitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Ileus
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    2
    0
    0
    Mouth haemorrhage
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    2
    0
    2
    Nausea
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    7 / 183 (3.83%)
         occurrences all number
    1
    0
    8
    Oral pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Pancreatitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Periodontal disease
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Proctalgia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Stomatitis
         subjects affected / exposed
    1 / 139 (0.72%)
    1 / 9 (11.11%)
    3 / 183 (1.64%)
         occurrences all number
    1
    3
    3
    Toothache
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    2
    0
    1
    Haematuria
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    4
    0
    2
    Renal failure
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Renal mass
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Urogenital haemorrhage
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Biliary dyskinesia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Cholecystitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Cholecystitis acute
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic failure
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    1
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Back pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Bone pain
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Muscular weakness
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    2
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Myositis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    4 / 183 (2.19%)
         occurrences all number
    2
    0
    4
    Alkalosis
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    4 / 183 (2.19%)
         occurrences all number
    2
    0
    4
    Decreased appetite
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    12 / 183 (6.56%)
         occurrences all number
    2
    0
    13
    Dehydration
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Hyperammonaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    11 / 139 (7.91%)
    1 / 9 (11.11%)
    15 / 183 (8.20%)
         occurrences all number
    18
    1
    23
    Hyperkalaemia
         subjects affected / exposed
    5 / 139 (3.60%)
    0 / 9 (0.00%)
    4 / 183 (2.19%)
         occurrences all number
    8
    0
    4
    Hypermagnesaemia
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    3
    0
    3
    Malnutrition
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    3
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    2
    0
    3
    Hypocalcaemia
         subjects affected / exposed
    4 / 139 (2.88%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    4
    0
    3
    Hypoglycaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    22 / 139 (15.83%)
    0 / 9 (0.00%)
    43 / 183 (23.50%)
         occurrences all number
    39
    0
    82
    Hypomagnesaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Hyponatraemia
         subjects affected / exposed
    6 / 139 (4.32%)
    1 / 9 (11.11%)
    8 / 183 (4.37%)
         occurrences all number
    7
    2
    9
    Hypophosphataemia
         subjects affected / exposed
    14 / 139 (10.07%)
    1 / 9 (11.11%)
    15 / 183 (8.20%)
         occurrences all number
    14
    1
    17
    Iron overload
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Hypernatraemia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    1
    0
    4
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    1
    0
    2
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    BK virus infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Bacillus infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Bacteraemia
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    6 / 183 (3.28%)
         occurrences all number
    2
    0
    6
    Bacterial infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    5 / 183 (2.73%)
         occurrences all number
    0
    0
    6
    Cystitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Device related infection
         subjects affected / exposed
    3 / 139 (2.16%)
    0 / 9 (0.00%)
    7 / 183 (3.83%)
         occurrences all number
    3
    0
    8
    Endophthalmitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Enterococcal infection
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    2
    0
    0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Enterovirus infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Fungaemia
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Fungal skin infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    1
    0
    1
    Lung infection
         subjects affected / exposed
    2 / 139 (1.44%)
    2 / 9 (22.22%)
    6 / 183 (3.28%)
         occurrences all number
    2
    2
    6
    Meningitis
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Micrococcal sepsis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Mucosal infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Myelitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Neutropenic sepsis
         subjects affected / exposed
    2 / 139 (1.44%)
    1 / 9 (11.11%)
    1 / 183 (0.55%)
         occurrences all number
    3
    1
    1
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Periorbital cellulitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    5 / 139 (3.60%)
    0 / 9 (0.00%)
    5 / 183 (2.73%)
         occurrences all number
    5
    0
    5
    Pneumonia fungal
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    4 / 183 (2.19%)
         occurrences all number
    0
    0
    4
    Pseudomonas infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Pulmonary mycosis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinovirus infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Sepsis
         subjects affected / exposed
    7 / 139 (5.04%)
    0 / 9 (0.00%)
    11 / 183 (6.01%)
         occurrences all number
    7
    0
    14
    Urinary tract infection
         subjects affected / exposed
    2 / 139 (1.44%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    2
    0
    2
    Sinusitis fungal
         subjects affected / exposed
    0 / 139 (0.00%)
    1 / 9 (11.11%)
    0 / 183 (0.00%)
         occurrences all number
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Stoma site infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    1 / 183 (0.55%)
         occurrences all number
    0
    0
    1
    Streptococcal sepsis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    2 / 183 (1.09%)
         occurrences all number
    0
    0
    2
    Subcutaneous abscess
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 139 (0.00%)
    0 / 9 (0.00%)
    3 / 183 (1.64%)
         occurrences all number
    0
    0
    3
    Systemic candida
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Viraemia
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 139 (0.72%)
    0 / 9 (0.00%)
    0 / 183 (0.00%)
         occurrences all number
    1
    0
    0

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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.
    Due to the expanded access to the protocol only, no efficacy evaluations were performed. The prioritization of the endpoints were based on study team discretion.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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