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    Clinical Trial Results:
    Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine

    Summary
    EudraCT number
    2009-016142-44
    Trial protocol
    DE   AT  
    Global end of trial date
    02 Oct 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Oct 2017
    First version publication date
    22 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AMLSG 12-09
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01180322
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University Hospital of Ulm
    Sponsor organisation address
    Albert-Einstein-Allee 23, Ulm, Germany, 89081
    Public contact
    Prof. Dr. Richard Schlenk, University Hospital of Ulm, 0049 73150045980, richard.schlenk@nct-heidelberg.de
    Scientific contact
    Prof. Dr. Richard Schlenk, University Hospital of Ulm, 0049 73150045980, richard.schlenk@nct-heidelberg.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Efficacy Objective • To evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on the CR rate Secondary Efficacy Objectives • To evaluate the impact of sequential or concurrent addition of 5-azacytidine to intensive induction chemotherapy with idarubicin and etoposide on RFS, EFS and OS • To evaluate the impact of 5-azacytidine maintenance therapy in patients achieving a CR on RFS and OS • To evaluate the efficacy of lenograstim based on duration of neutro- and leukopenia as well as incidence of infection and duration of hospitalization after consolidation therapy • Assessment of quality of life Safety Objectives • Evaluation of safety based on toxicity induced by 5-azacytidine
    Protection of trial subjects
    In this study, safety was assessed by evaluating the following: reported adverse events, clinical laboratory test results, vital signs measurements, ECG findings, chest X-ray, echo scan, physical examination findings, monitoring of concomitant therapy. For each safety parameter, all findings (whether normal or abnormal) were recorded in the CRF.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 21
    Country: Number of subjects enrolled
    Germany: 256
    Worldwide total number of subjects
    277
    EEA total number of subjects
    277
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    161
    From 65 to 84 years
    116
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First Patient in: 22.10.2010 Last Patient in: 03.04.2012 Recruitment was not interrupted, but randomization into Treatment arms B and C was stopped with effective date 16 September 2011 due to unsufficient efficacy.

    Pre-assignment
    Screening details
    Molecular genetic analysis (central AMLSG reference lab) of blood and bone marrow was performed at baseline within 48 hours to make an enrollment possible.

    Pre-assignment period milestones
    Number of subjects started
    277
    Number of subjects completed
    268

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Violation of inclusion/exclusion criteria: 6
    Reason: Number of subjects
    Consent withdrawn by subject: 2
    Reason: Number of subjects
    Other: 1
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm A: Standard
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 100 mg/m2/day by continuous IV infusion on days 1-7 (total dose 700 mg/m2) Consolidation therapy: Younger adults (18 to 65 yrs): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2). Elderly patients (>65 yrs): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2).

    Investigational medicinal product name
    Idarubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy cycle 1: 12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin were foreseen on days 1+3. Induction therapy cycle 2: 12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups).

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide were foreseen on days 1+3.

    Arm title
    Arm B: Aza prior
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder, dispersion and solvent for concentrate for dispersion for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Induction therapy: 100 mg/m2/day by SC injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine was given prior to idarubicin and etoposide.

    Investigational medicinal product name
    Idarubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy cycle 1: 12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin were foreseen on days 6+8. Induction therapy cycle 2: 12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups).

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide were foreseen on days 6+8.

    Arm title
    Arm C: Aza concurrent
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder, dispersion and solvent for concentrate for dispersion for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Induction therapy:100 mg/m2/day by SC injection or 15-minute IV infusion on days 1-5 (total dose 500 mg/m2). Azacitidine was given prior to idarubicin and etoposide..

    Investigational medicinal product name
    Idarubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy cycle 1: 12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin were foreseen on days 1+3. Induction therapy cycle 2: 12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups).

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide were foreseen on days 1+3.

    Arm title
    Arm D: Aza after
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder, dispersion and solvent for concentrate for dispersion for infusion
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Induction therapy:100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine was given prior to idarubicin and etoposide.

    Investigational medicinal product name
    Idarubicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy cycle 1: 12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin were foreseen on days 1+3. Induction therapy cycle 2: 12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups).

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide were foreseen on days 1+3.

    Number of subjects in period 1 [1]
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Started
    100
    35
    34
    99
    Completed
    39
    6
    5
    22
    Not completed
    61
    29
    29
    77
         Other
    4
    -
    1
    3
         Lack of efficacy
    40
    22
    24
    57
         Adverse event, serious fatal
    4
    3
    2
    8
         Adverse event, non-fatal
    11
    4
    1
    7
         Consent withdrawn by subject
    2
    -
    1
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 277 patients who were enrolled to the study 9 patients were excluded due to violation of inclusion/exclusion criteria (n=6: no presence of AML n=3, AML with NPM1 mutation n=1, presence of Philadelphia chromosome n=1, organ insufficiency (renal failure) n=1), withdrawal of informed consent (n=2) and other reason (extramedullary manifestation of AML in spleen, n=1).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A: Standard
    Reporting group description
    -

    Reporting group title
    Arm B: Aza prior
    Reporting group description
    -

    Reporting group title
    Arm C: Aza concurrent
    Reporting group description
    -

    Reporting group title
    Arm D: Aza after
    Reporting group description
    -

    Reporting group values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Total
    Number of subjects
    100 35 34 99 268
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    62.6 (19 to 81) 63.5 (20 to 79) 63.6 (36 to 82) 62.3 (18 to 79) -
    Gender categorical
    Units: Subjects
        Female
    51 14 20 39 124
        Male
    49 21 14 60 144
    ECOG Performance Status
    Units: Subjects
        ECOG 0
    42 16 13 42 113
        ECOG 1
    53 16 20 47 136
        ECOG 2
    5 3 1 10 19
    Type of AML
    Units: Subjects
        De Novo AML
    73 24 24 76 197
        sAML
    16 8 8 18 50
        tAML
    11 3 2 5 21
    CEBPA mutation status
    Units: Subjects
        Wildtype
    82 28 29 76 215
        Single mutation
    4 0 0 2 6
        Double mutation
    7 1 1 8 17
        Not recorded
    7 6 4 13 30
    DNMT3A mutation status
    Units: Subjects
        Wildtype
    76 23 24 72 195
        Mutation
    17 6 6 11 40
        Not recorded
    7 6 4 16 33
    ASXL1 mutation status
    Units: Subjects
        Wildtype
    66 22 26 67 181
        Mutation
    16 5 2 9 32
        Not recorded
    18 8 6 23 55
    RUNX1 mutation status
    Units: Subjects
        Wildtype
    78 19 21 69 187
        Mutation
    15 8 9 14 46
        not recorded
    7 8 4 16 35
    IDH1 mutation status
    Units: Subjects
        Wildtype
    79 24 26 77 206
        Mutation
    13 3 3 6 25
        not recorded
    8 8 5 16 37
    IDH2 mutation status
    Units: Subjects
        Wildtype
    77 25 23 63 188
        Mutation
    5 3 6 13 27
        not recorded
    18 7 5 23 53
    ELN 2010 classification
    Units: Subjects
        Favorable
    7 1 0 6 14
        Intermediate-I
    31 9 11 28 79
        Intermediate-II
    16 12 9 23 60
        Adverse
    30 11 5 31 77
        not applicable
    16 2 9 11 38
    Hemoglobin (g/dl)
    Units: g/dl
        median (full range (min-max))
    9.1 (5.2 to 12.9) 9.8 (5.9 to 12.9) 9.6 (6.9 to 13.6) 9.1 (5.6 to 13.8) -
    Platelets (G/l)
    Units: G/l
        median (full range (min-max))
    64.5 (3 to 419) 61 (16 to 1286) 53 (12 to 301) 67 (4 to 956) -
    White blood count (G/l)
    Units: G/l
        median (full range (min-max))
    3.0 (0.4 to 186.0) 3.4 (0.8 to 155.2) 3.6 (0.6 to 141.3) 4.2 (0.3 to 214.0) -
    Bone marrow blasts (%)
    Units: percent
        median (full range (min-max))
    53 (0 to 100) 63.5 (10 to 100) 61.5 (20 to 93) 60 (0 to 99) -
    Peripheral blood blasts (%)
    Units: percent
        median (full range (min-max))
    12 (0 to 97) 16 (0 to 88) 5 (0 to 92) 8.5 (0 to 97) -
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set contained all patients scheduled for study treatment.

    Subject analysis set title
    Primary endpoint analysis set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Data of all patients scheduled for study treatment (n=268) were considered for efficacy and safety analyses. According to statistical analysis planning, 220 eligible patients were included into analysis of primary endpoint (= primary endpoint analysis set).

    Subject analysis sets values
    Full analysis set Primary endpoint analysis set
    Number of subjects
    268
    220
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    62.6 (18 to 82)
    Gender categorical
    Units: Subjects
        Female
    124
        Male
    144
    ECOG Performance Status
    Units: Subjects
        ECOG 0
    113
        ECOG 1
    136
        ECOG 2
    19
    Type of AML
    Units: Subjects
        De Novo AML
    197
        sAML
    50
        tAML
    21
    CEBPA mutation status
    Units: Subjects
        Wildtype
    215
        Single mutation
    6
        Double mutation
    17
        Not recorded
    30
    DNMT3A mutation status
    Units: Subjects
        Wildtype
    195
        Mutation
    40
        Not recorded
    33
    ASXL1 mutation status
    Units: Subjects
        Wildtype
    181
        Mutation
    32
        Not recorded
    55
    RUNX1 mutation status
    Units: Subjects
        Wildtype
    187
        Mutation
    46
        not recorded
    35
    IDH1 mutation status
    Units: Subjects
        Wildtype
    206
        Mutation
    25
        not recorded
    37
    IDH2 mutation status
    Units: Subjects
        Wildtype
    188
        Mutation
    27
        not recorded
    53
    ELN 2010 classification
    Units: Subjects
        Favorable
    14
        Intermediate-I
    79
        Intermediate-II
    60
        Adverse
    77
        not applicable
    38
    Hemoglobin (g/dl)
    Units: g/dl
        median (full range (min-max))
    9.2 (5.2 to 13.8)
    Platelets (G/l)
    Units: G/l
        median (full range (min-max))
    63.5 (3 to 1286)
    White blood count (G/l)
    Units: G/l
        median (full range (min-max))
    3.7 (0.3 to 214.0)
    Bone marrow blasts (%)
    Units: percent
        median (full range (min-max))
    60 (0 to 100)
    Peripheral blood blasts (%)
    Units: percent
        median (full range (min-max))
    10 (0 to 97)

    End points

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    End points reporting groups
    Reporting group title
    Arm A: Standard
    Reporting group description
    -

    Reporting group title
    Arm B: Aza prior
    Reporting group description
    -

    Reporting group title
    Arm C: Aza concurrent
    Reporting group description
    -

    Reporting group title
    Arm D: Aza after
    Reporting group description
    -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The full analysis set contained all patients scheduled for study treatment.

    Subject analysis set title
    Primary endpoint analysis set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Data of all patients scheduled for study treatment (n=268) were considered for efficacy and safety analyses. According to statistical analysis planning, 220 eligible patients were included into analysis of primary endpoint (= primary endpoint analysis set).

    Primary: CR rate after induction therapy (primary endpoint analysis set)

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    End point title
    CR rate after induction therapy (primary endpoint analysis set) [1]
    End point description
    The null hypothesis in each arm was H0: π ≤ 0.40, whereby π denoted the true CR rate of the induction therapy. In contrast, an effective therapy should achieve at least a CR rate of 55%. The sample size was calculated to detect an effective therapy with a power of 80%. The level of significance was fixed at α=5% for each treatment arm. Based on the „optimal two-stage design“ of Simon, an efficacy of the corresponding therapy would be rejected in the first stage of 26 treated patients, if 11 or less patients achieved a CR (or CRi). If 12 or more patients achieved a CR (or CRi) during this first stage, the trial would be continued to second stage with a total sample size of 84 patients per treatment arm. If more than 40 of 84 evaluable patients achieved a CR (or CRi), the null hypothesis of the corresponding treatment arm could be rejected and the treatment arm could be judged as effective therapy.
    End point type
    Primary
    End point timeframe
    after induction therapy (two months)
    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: Primary endpoint was analyzed according to Simon's two stage design. An effective therapy should have achieved a CR in more than 40 of 84 patients. The null hypothesis for treatment arm D could not be rejected, since there were only 37 patients who achieved a CR/CRi. Since 45 patients achieved a CR/CRi in arm A, the standard arm was judged as the sole effective treatment arm of the study with an estimated CR rate of 55.5% and a lower limit of a one-sided 95% confidence interval of 46.3%.
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Primary endpoint analysis set
    Number of subjects analysed
    84
    26
    26
    84
    220
    Units: Subjects with Complete remission
    45
    11
    10
    37
    103
    No statistical analyses for this end point

    Secondary: CR rate after induction therapy (full data set)

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    End point title
    CR rate after induction therapy (full data set)
    End point description
    End point type
    Secondary
    End point timeframe
    CR rate after induction therapy (two months)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    100
    35
    34
    99
    268
    Units: Subjects with complete remission
    54
    14
    12
    46
    126
    No statistical analyses for this end point

    Secondary: Event-free Survival after four years

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    End point title
    Event-free Survival after four years
    End point description
    As events the following were considered according to study protocol: death during induction therapy, refractory disease after first induction therapy, refractory disease or partial response after second induction therapy, relapse and death in CR. Time between study entry and occurrence of the first event was analyzed.
    End point type
    Secondary
    End point timeframe
    after four years
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    100
    35
    34
    99
    268
    Units: Percentage
        number (confidence interval 95%)
    23.8 (16.6 to 34.2)
    8.6 (2.9 to 25.3)
    19.0 (9.3 to 38.7)
    10.1 (5.6 to 18.2)
    16.1 (12.2 to 21.2)
    No statistical analyses for this end point

    Secondary: Relapse-free Survival after four years

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    End point title
    Relapse-free Survival after four years
    End point description
    End point type
    Secondary
    End point timeframe
    after four years
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    54
    14
    12
    46
    126
    Units: Percentage
        number (confidence interval 95%)
    36.0 (25.1 to 51.7)
    21.4 (7.9 to 58.4)
    41.7 (21.3 to 81.4)
    21.7 (12.6 to 37.6)
    29.8 (22.8 to 39.0)
    No statistical analyses for this end point

    Secondary: Cumulative incidence of relapse

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    End point title
    Cumulative incidence of relapse
    End point description
    End point type
    Secondary
    End point timeframe
    after four years
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    54
    14
    12
    46
    126
    Units: Percentage
        number (not applicable)
    50.9
    57.1
    50.0
    60.9
    55.0
    No statistical analyses for this end point

    Secondary: Cumulative incidence of death

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    End point title
    Cumulative incidence of death
    End point description
    End point type
    Secondary
    End point timeframe
    after four years
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    54
    14
    12
    46
    126
    Units: Percentage
        number (not applicable)
    13.1
    21.4
    8.3
    17.4
    15.2
    No statistical analyses for this end point

    Secondary: Overall survival after four years

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    End point title
    Overall survival after four years
    End point description
    End point type
    Secondary
    End point timeframe
    after four years
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    100
    35
    34
    99
    268
    Units: Percentage
        number (confidence interval 95%)
    36.6 (28.1 to 47.6)
    20.0 (10.3 to 38.8)
    29.4 (17.5 to 49.5)
    25.5 (4.5 to 38.1)
    29.4 (24.3 to 35.4)
    No statistical analyses for this end point

    Secondary: Nights in hospital (overall trial)

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    End point title
    Nights in hospital (overall trial)
    End point description
    End point type
    Secondary
    End point timeframe
    Whole Trial (max. 30 months)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    100
    35
    34
    99
    268
    Units: Nights
        median (full range (min-max))
    65 (16 to 171)
    40 (14 to 150)
    43.5 (18 to 156)
    58 (3 to 172)
    55 (3 to 172)
    No statistical analyses for this end point

    Secondary: Median duration of Leukopenia after consolidation therapy

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    End point title
    Median duration of Leukopenia after consolidation therapy
    End point description
    End point type
    Secondary
    End point timeframe
    within the first six months of therapy
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Number of subjects analysed
    26
    4
    7
    24
    Units: Days
    number (not applicable)
        Consolidation cycle 1
    16
    16
    14
    15.5
        Consolidation cycle 2
    17
    15
    15
    15
        Consolidation cycle 3
    17.5
    15
    22.5
    15
    No statistical analyses for this end point

    Secondary: Median duration of neutropenia after consolidation therapy

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    End point title
    Median duration of neutropenia after consolidation therapy
    End point description
    End point type
    Secondary
    End point timeframe
    within the first six months of therapy
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Number of subjects analysed
    22
    3
    7
    22
    Units: Days
    number (not applicable)
        Consolidation cycle 1
    18
    16
    24
    18
        Consolidation cycle 2
    18
    16
    16
    15
        Consolidation cycle 3
    19.5
    17
    27
    17
    No statistical analyses for this end point

    Secondary: Median duration of thrombocytopenia after consolidation therapy

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    End point title
    Median duration of thrombocytopenia after consolidation therapy
    End point description
    End point type
    Secondary
    End point timeframe
    within the first six months of therapy
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Number of subjects analysed
    26
    4
    7
    24
    Units: Days
    number (not applicable)
        Consolidation cycle 1
    22
    20
    17
    16
        Consolidation cycle 2
    28
    18
    19
    18
        Consolidation cycle 3
    20
    17
    23.5
    16.5
    No statistical analyses for this end point

    Secondary: Quality of Health (Global health status)

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    End point title
    Quality of Health (Global health status)
    End point description
    End point type
    Secondary
    End point timeframe
    at baseline and at the end of Treatment (maximal after 30 months)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    33
    4
    7
    37
    81
    Units: Score value %
    median (full range (min-max))
        Baseline
    50 (16.7 to 83.3)
    54.2 (16.7 to 100)
    33.3 (16.7 to 100)
    50 (0 to 100)
    50 (0 to 100)
        End of treatment
    75 (16.7 to 100)
    41.7 (16.7 to 50)
    41.7 (41.7 to 41.7)
    58.3 (33.3 to 83.3)
    66.7 (16.7 to 100)
    No statistical analyses for this end point

    Secondary: Rate of Early / Hypoplastic Death (ED/HD)

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    End point title
    Rate of Early / Hypoplastic Death (ED/HD)
    End point description
    End point type
    Secondary
    End point timeframe
    within the first two months of therapy (induction therapy)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after Full analysis set
    Number of subjects analysed
    100
    35
    34
    99
    268
    Units: Rate
        number (confidence interval 95%)
    2.0 (0.6 to 7.0)
    5.7 (1.6 to 18.6)
    5.9 (1.6 to 19.0)
    6.0 (2.8 to 12.6)
    4.5 (2.6 to 7.7)
    No statistical analyses for this end point

    Secondary: Median duration of leukopenia after induction therapy

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    End point title
    Median duration of leukopenia after induction therapy
    End point description
    End point type
    Secondary
    End point timeframe
    within the first two months (induction therapy)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Number of subjects analysed
    100
    34
    34
    98
    Units: Days
    number (not applicable)
        Induction cycle 1
    24
    27
    25
    27
        Induction cycle 2
    26
    26
    25
    25
    No statistical analyses for this end point

    Secondary: Median duration of neutropenia after induction therapy

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    End point title
    Median duration of neutropenia after induction therapy
    End point description
    End point type
    Secondary
    End point timeframe
    within the first two months (induction therapy)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Number of subjects analysed
    82
    28
    29
    81
    Units: Days
    number (not applicable)
        Induction cycle 1
    31
    30
    40
    33
        Induction cycle 2
    36
    31
    35
    35
    No statistical analyses for this end point

    Secondary: Median duration of thrombocytopenia after induction therapy

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    End point title
    Median duration of thrombocytopenia after induction therapy
    End point description
    End point type
    Secondary
    End point timeframe
    within the first two months (induction therapy)
    End point values
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Number of subjects analysed
    100
    34
    34
    98
    Units: Days
    number (not applicable)
        Induction cycle 1
    25
    29
    28
    22
        Induction cycle 2
    26
    23
    25
    19
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse event reporting period for this trial began upon signing of informed consent and ended 28 days after the last treatment Administration.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Arm A: Standard
    Reporting group description
    -

    Reporting group title
    Arm B: Aza prior
    Reporting group description
    -

    Reporting group title
    Arm C: Aza concurrent
    Reporting group description
    -

    Reporting group title
    Arm D: Aza after
    Reporting group description
    -

    Serious adverse events
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 100 (30.00%)
    11 / 35 (31.43%)
    12 / 34 (35.29%)
    32 / 99 (32.32%)
         number of deaths (all causes)
    4
    3
    2
    8
         number of deaths resulting from adverse events
    4
    3
    2
    8
    Vascular disorders
    CNS Hemorrhage
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemorrhage pulmonary
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemorrhage, GU
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis/embolism
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Allergy - Other
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytes
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Constitutional symptoms - other
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death not associated with CTCAE
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    3 / 99 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 3
    Cardiac disorders
    Supraventricular arrhythmia
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac general - other
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac ischemia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary arrest
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restrictive cardiomyopathy
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ARDS
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Dyspnea
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood - Other
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone marrow cellularity
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemoglobin
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophils
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelets
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic function
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Confusion
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Diarrhea
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucositis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain - Gastrointestinal: Abdomen NOS
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Cystitis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal - other
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal - other: Fluid retention/edema
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary - other
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver dysfunction
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatology - Other
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal - other
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain - Musculoskeletal: joint
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Diabetes
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 35 (2.86%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Febrile neutropenia
         subjects affected / exposed
    3 / 100 (3.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
    3 / 99 (3.03%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection - Catheter-related
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection - Gastrointestinal Abdomen NOS
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 35 (0.00%)
    1 / 34 (2.94%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection - Gastrointestinal anal/perianal
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection - Gastrointestinal - Appendix
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection - other
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    1 / 99 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 35 (8.57%)
    5 / 34 (14.71%)
    9 / 99 (9.09%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 3
    3 / 5
    5 / 9
         deaths causally related to treatment / all
    1 / 2
    0 / 2
    1 / 2
    2 / 3
    Infection with grade 3/4 neutrophils
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 35 (0.00%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection - Soft tissue NOS
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 35 (5.71%)
    0 / 34 (0.00%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung (Pneumonia)
         subjects affected / exposed
    5 / 100 (5.00%)
    1 / 35 (2.86%)
    3 / 34 (8.82%)
    4 / 99 (4.04%)
         occurrences causally related to treatment / all
    4 / 5
    1 / 1
    2 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Arm A: Standard Arm B: Aza prior Arm C: Aza concurrent Arm D: Aza after
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    100 / 100 (100.00%)
    35 / 35 (100.00%)
    34 / 34 (100.00%)
    99 / 99 (100.00%)
    Vascular disorders
    Hematoma
         subjects affected / exposed
    15 / 100 (15.00%)
    2 / 35 (5.71%)
    4 / 34 (11.76%)
    9 / 99 (9.09%)
         occurrences all number
    27
    2
    5
    9
    Hemorrhage pulmonary
         subjects affected / exposed
    22 / 100 (22.00%)
    3 / 35 (8.57%)
    7 / 34 (20.59%)
    20 / 99 (20.20%)
         occurrences all number
    31
    3
    10
    27
    Hemorrhage, GI
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 35 (8.57%)
    2 / 34 (5.88%)
    6 / 99 (6.06%)
         occurrences all number
    7
    4
    2
    9
    Petechiae
         subjects affected / exposed
    17 / 100 (17.00%)
    7 / 35 (20.00%)
    7 / 34 (20.59%)
    19 / 99 (19.19%)
         occurrences all number
    30
    9
    10
    21
    Phlebitis
         subjects affected / exposed
    6 / 100 (6.00%)
    7 / 35 (20.00%)
    2 / 34 (5.88%)
    8 / 99 (8.08%)
         occurrences all number
    7
    10
    2
    10
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    19 / 100 (19.00%)
    5 / 35 (14.29%)
    4 / 34 (11.76%)
    19 / 99 (19.19%)
         occurrences all number
    23
    7
    10
    28
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    22 / 100 (22.00%)
    7 / 35 (20.00%)
    6 / 34 (17.65%)
    19 / 99 (19.19%)
         occurrences all number
    39
    9
    9
    26
    Fever neonatal
         subjects affected / exposed
    38 / 100 (38.00%)
    8 / 35 (22.86%)
    11 / 34 (32.35%)
    33 / 99 (33.33%)
         occurrences all number
    87
    23
    13
    53
    Insomnia
         subjects affected / exposed
    35 / 100 (35.00%)
    6 / 35 (17.14%)
    9 / 34 (26.47%)
    38 / 99 (38.38%)
         occurrences all number
    84
    12
    15
    52
    Rigors/chills
         subjects affected / exposed
    8 / 100 (8.00%)
    0 / 35 (0.00%)
    5 / 34 (14.71%)
    1 / 99 (1.01%)
         occurrences all number
    10
    0
    5
    1
    Weight gain
         subjects affected / exposed
    22 / 100 (22.00%)
    4 / 35 (11.43%)
    3 / 34 (8.82%)
    13 / 99 (13.13%)
         occurrences all number
    36
    6
    6
    19
    Pain NOS
         subjects affected / exposed
    18 / 100 (18.00%)
    5 / 35 (14.29%)
    8 / 34 (23.53%)
    8 / 99 (8.08%)
         occurrences all number
    23
    5
    16
    8
    Pain - other
         subjects affected / exposed
    8 / 100 (8.00%)
    3 / 35 (8.57%)
    4 / 34 (11.76%)
    6 / 99 (6.06%)
         occurrences all number
    10
    3
    5
    7
    Investigations
    Coagulation - other
         subjects affected / exposed
    10 / 100 (10.00%)
    3 / 35 (8.57%)
    3 / 34 (8.82%)
    5 / 99 (5.05%)
         occurrences all number
    13
    3
    5
    7
    ALT
         subjects affected / exposed
    7 / 100 (7.00%)
    2 / 35 (5.71%)
    3 / 34 (8.82%)
    4 / 99 (4.04%)
         occurrences all number
    14
    2
    5
    4
    AST
         subjects affected / exposed
    7 / 100 (7.00%)
    2 / 35 (5.71%)
    2 / 34 (5.88%)
    2 / 99 (2.02%)
         occurrences all number
    10
    3
    5
    2
    Bilirubin
         subjects affected / exposed
    14 / 100 (14.00%)
    1 / 35 (2.86%)
    2 / 34 (5.88%)
    6 / 99 (6.06%)
         occurrences all number
    19
    1
    2
    6
    Creatinine
         subjects affected / exposed
    7 / 100 (7.00%)
    2 / 35 (5.71%)
    3 / 34 (8.82%)
    8 / 99 (8.08%)
         occurrences all number
    9
    3
    5
    12
    Hyperglycemia
         subjects affected / exposed
    5 / 100 (5.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    8 / 99 (8.08%)
         occurrences all number
    6
    1
    1
    11
    Hyperuricemia
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 35 (5.71%)
    4 / 34 (11.76%)
    4 / 99 (4.04%)
         occurrences all number
    8
    3
    4
    4
    Hypocalcemia
         subjects affected / exposed
    9 / 100 (9.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    8 / 99 (8.08%)
         occurrences all number
    14
    3
    1
    11
    Hypokalemia
         subjects affected / exposed
    57 / 100 (57.00%)
    8 / 35 (22.86%)
    12 / 34 (35.29%)
    38 / 99 (38.38%)
         occurrences all number
    115
    20
    22
    67
    Hypomagnesemia
         subjects affected / exposed
    9 / 100 (9.00%)
    2 / 35 (5.71%)
    2 / 34 (5.88%)
    13 / 99 (13.13%)
         occurrences all number
    14
    2
    2
    14
    Hyponatremia
         subjects affected / exposed
    5 / 100 (5.00%)
    0 / 35 (0.00%)
    4 / 34 (11.76%)
    4 / 99 (4.04%)
         occurrences all number
    6
    0
    4
    6
    Investigations: other
         subjects affected / exposed
    14 / 100 (14.00%)
    2 / 35 (5.71%)
    3 / 34 (8.82%)
    8 / 99 (8.08%)
         occurrences all number
    36
    7
    4
    13
    CRP increase
         subjects affected / exposed
    15 / 100 (15.00%)
    3 / 35 (8.57%)
    5 / 34 (14.71%)
    5 / 99 (5.05%)
         occurrences all number
    25
    10
    9
    6
    Cardiac disorders
    Supraventricular arrhythmia
         subjects affected / exposed
    8 / 100 (8.00%)
    3 / 35 (8.57%)
    7 / 34 (20.59%)
    12 / 99 (12.12%)
         occurrences all number
    11
    3
    9
    18
    Hypertension
         subjects affected / exposed
    24 / 100 (24.00%)
    9 / 35 (25.71%)
    6 / 34 (17.65%)
    19 / 99 (19.19%)
         occurrences all number
    33
    10
    18
    27
    Hypotension
         subjects affected / exposed
    9 / 100 (9.00%)
    1 / 35 (2.86%)
    2 / 34 (5.88%)
    5 / 99 (5.05%)
         occurrences all number
    11
    1
    2
    7
    Blood and lymphatic system disorders
    Hemoglobin
         subjects affected / exposed
    95 / 100 (95.00%)
    28 / 35 (80.00%)
    28 / 34 (82.35%)
    85 / 99 (85.86%)
         occurrences all number
    247
    53
    63
    214
    Leukocytes
         subjects affected / exposed
    72 / 100 (72.00%)
    24 / 35 (68.57%)
    25 / 34 (73.53%)
    70 / 99 (70.71%)
         occurrences all number
    180
    48
    62
    192
    Neutrophils
         subjects affected / exposed
    38 / 100 (38.00%)
    15 / 35 (42.86%)
    14 / 34 (41.18%)
    42 / 99 (42.42%)
         occurrences all number
    94
    28
    31
    80
    Platelets
         subjects affected / exposed
    95 / 100 (95.00%)
    29 / 35 (82.86%)
    28 / 34 (82.35%)
    87 / 99 (87.88%)
         occurrences all number
    256
    55
    73
    234
    Respiratory, thoracic and mediastinal disorders
    Pain chest/thorax
         subjects affected / exposed
    6 / 100 (6.00%)
    4 / 35 (11.43%)
    2 / 34 (5.88%)
    3 / 99 (3.03%)
         occurrences all number
    7
    4
    3
    3
    Pain throat/pharynx
         subjects affected / exposed
    8 / 100 (8.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    8 / 99 (8.08%)
         occurrences all number
    9
    1
    1
    9
    Cough
         subjects affected / exposed
    12 / 100 (12.00%)
    4 / 35 (11.43%)
    5 / 34 (14.71%)
    25 / 99 (25.25%)
         occurrences all number
    15
    6
    5
    29
    Dyspnea
         subjects affected / exposed
    11 / 100 (11.00%)
    4 / 35 (11.43%)
    5 / 34 (14.71%)
    12 / 99 (12.12%)
         occurrences all number
    18
    5
    8
    15
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    18 / 100 (18.00%)
    7 / 35 (20.00%)
    6 / 34 (17.65%)
    11 / 99 (11.11%)
         occurrences all number
    28
    7
    6
    18
    Agitation
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 35 (8.57%)
    3 / 34 (8.82%)
    6 / 99 (6.06%)
         occurrences all number
    6
    3
    3
    8
    Anxiety
         subjects affected / exposed
    11 / 100 (11.00%)
    4 / 35 (11.43%)
    5 / 34 (14.71%)
    9 / 99 (9.09%)
         occurrences all number
    19
    5
    5
    11
    Depression
         subjects affected / exposed
    7 / 100 (7.00%)
    5 / 35 (14.29%)
    6 / 34 (17.65%)
    17 / 99 (17.17%)
         occurrences all number
    11
    8
    7
    19
    Head/Headache
         subjects affected / exposed
    25 / 100 (25.00%)
    9 / 35 (25.71%)
    5 / 34 (14.71%)
    19 / 99 (19.19%)
         occurrences all number
    44
    17
    7
    25
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    16 / 100 (16.00%)
    5 / 35 (14.29%)
    4 / 34 (11.76%)
    12 / 99 (12.12%)
         occurrences all number
    20
    5
    7
    16
    Constipation
         subjects affected / exposed
    38 / 100 (38.00%)
    12 / 35 (34.29%)
    10 / 34 (29.41%)
    33 / 99 (33.33%)
         occurrences all number
    61
    16
    19
    51
    Diarrhea
         subjects affected / exposed
    51 / 100 (51.00%)
    13 / 35 (37.14%)
    11 / 34 (32.35%)
    38 / 99 (38.38%)
         occurrences all number
    89
    20
    17
    57
    Heartburn
         subjects affected / exposed
    6 / 100 (6.00%)
    1 / 35 (2.86%)
    4 / 34 (11.76%)
    7 / 99 (7.07%)
         occurrences all number
    12
    2
    6
    9
    Mucositis
         subjects affected / exposed
    39 / 100 (39.00%)
    8 / 35 (22.86%)
    13 / 34 (38.24%)
    43 / 99 (43.43%)
         occurrences all number
    56
    10
    16
    49
    Nausea
         subjects affected / exposed
    61 / 100 (61.00%)
    18 / 35 (51.43%)
    23 / 34 (67.65%)
    57 / 99 (57.58%)
         occurrences all number
    128
    33
    51
    109
    Vomiting
         subjects affected / exposed
    28 / 100 (28.00%)
    10 / 35 (28.57%)
    15 / 34 (44.12%)
    30 / 99 (30.30%)
         occurrences all number
    40
    12
    22
    47
    Pain Abdomen NOS
         subjects affected / exposed
    22 / 100 (22.00%)
    6 / 35 (17.14%)
    5 / 34 (14.71%)
    17 / 99 (17.17%)
         occurrences all number
    32
    7
    5
    19
    Pain Stomach
         subjects affected / exposed
    10 / 100 (10.00%)
    8 / 35 (22.86%)
    4 / 34 (11.76%)
    12 / 99 (12.12%)
         occurrences all number
    14
    9
    5
    17
    Renal and urinary disorders
    Fluid retention/edema
         subjects affected / exposed
    53 / 100 (53.00%)
    12 / 35 (34.29%)
    17 / 34 (50.00%)
    42 / 99 (42.42%)
         occurrences all number
    89
    30
    32
    68
    Skin and subcutaneous tissue disorders
    Dermatology - other
         subjects affected / exposed
    11 / 100 (11.00%)
    4 / 35 (11.43%)
    2 / 34 (5.88%)
    10 / 99 (10.10%)
         occurrences all number
    15
    8
    6
    12
    Injection site reaction
         subjects affected / exposed
    15 / 100 (15.00%)
    8 / 35 (22.86%)
    9 / 34 (26.47%)
    24 / 99 (24.24%)
         occurrences all number
    23
    12
    24
    45
    Pruritus
         subjects affected / exposed
    11 / 100 (11.00%)
    2 / 35 (5.71%)
    2 / 34 (5.88%)
    9 / 99 (9.09%)
         occurrences all number
    17
    3
    2
    10
    Rash
         subjects affected / exposed
    31 / 100 (31.00%)
    9 / 35 (25.71%)
    11 / 34 (32.35%)
    27 / 99 (27.27%)
         occurrences all number
    57
    16
    16
    45
    Musculoskeletal and connective tissue disorders
    Musculoskeletal - other
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 35 (8.57%)
    1 / 34 (2.94%)
    8 / 99 (8.08%)
         occurrences all number
    6
    3
    1
    12
    Pain back
         subjects affected / exposed
    17 / 100 (17.00%)
    3 / 35 (8.57%)
    3 / 34 (8.82%)
    12 / 99 (12.12%)
         occurrences all number
    23
    3
    4
    16
    Pain bone
         subjects affected / exposed
    7 / 100 (7.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
    6 / 99 (6.06%)
         occurrences all number
    9
    2
    1
    7
    Pain Extremity/Limb
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 35 (5.71%)
    2 / 34 (5.88%)
    9 / 99 (9.09%)
         occurrences all number
    8
    2
    2
    16
    Pain: Joint
         subjects affected / exposed
    4 / 100 (4.00%)
    4 / 35 (11.43%)
    1 / 34 (2.94%)
    8 / 99 (8.08%)
         occurrences all number
    7
    4
    1
    12
    Infections and infestations
    Infection: Lip/perioral
         subjects affected / exposed
    9 / 100 (9.00%)
    4 / 35 (11.43%)
    1 / 34 (2.94%)
    12 / 99 (12.12%)
         occurrences all number
    12
    4
    1
    12
    Febrile neutropenia
         subjects affected / exposed
    52 / 100 (52.00%)
    18 / 35 (51.43%)
    16 / 34 (47.06%)
    43 / 99 (43.43%)
         occurrences all number
    91
    24
    27
    73
    Infection: Catheter-related
         subjects affected / exposed
    12 / 100 (12.00%)
    9 / 35 (25.71%)
    3 / 34 (8.82%)
    13 / 99 (13.13%)
         occurrences all number
    17
    10
    5
    13
    Infection - other
         subjects affected / exposed
    32 / 100 (32.00%)
    5 / 35 (14.29%)
    6 / 34 (17.65%)
    29 / 99 (29.29%)
         occurrences all number
    58
    8
    7
    42
    Sepsis
         subjects affected / exposed
    23 / 100 (23.00%)
    5 / 35 (14.29%)
    8 / 34 (23.53%)
    14 / 99 (14.14%)
         occurrences all number
    36
    9
    14
    28
    Infection with grade 3/4 neutrophils
         subjects affected / exposed
    8 / 100 (8.00%)
    1 / 35 (2.86%)
    1 / 34 (2.94%)
    3 / 99 (3.03%)
         occurrences all number
    13
    1
    1
    3
    Infection with unknown ANC
         subjects affected / exposed
    5 / 100 (5.00%)
    2 / 35 (5.71%)
    1 / 34 (2.94%)
    11 / 99 (11.11%)
         occurrences all number
    11
    2
    3
    14
    Lung (pneumonia)
         subjects affected / exposed
    23 / 100 (23.00%)
    9 / 35 (25.71%)
    4 / 34 (11.76%)
    19 / 99 (19.19%)
         occurrences all number
    35
    11
    9
    29
    Infection: Urinary tract NOS
         subjects affected / exposed
    7 / 100 (7.00%)
    1 / 35 (2.86%)
    3 / 34 (8.82%)
    3 / 99 (3.03%)
         occurrences all number
    11
    1
    3
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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