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    Clinical Trial Results:
    A phase III, multicentre, randomized, open label clinical trial comparing azacytidine (Vidaza®) versus fludarabine plus cytarabine in elderly patients with newly diagnosed acute myeloid leukemia.

    Summary
    EudraCT number
    		 2014-000319-15
    Trial protocol
    		 ES  
    Global end of trial date
    28 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2021
    First version publication date
    23 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FLUGAZA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02319135
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación PETHEMA
    Sponsor organisation address
    C/ Profesor Martín Lagos s/n, Madrid, Spain, 28040
    Public contact
    Gerencia Fundación Pethema, Fundación PETHEMA, +34 91 6266232, gerencia@fundacionpethema.es
    Scientific contact
    Gerencia Fundación Pethema, Fundación PETHEMA, +34 91 6266232, gerencia@fundacionpethema.es
    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
    28 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the overall survival (OS) in one year treatment with 2 first-line regimens in newly diagnosed elderly patients: 3 cycles of induction chemotherapy based on fludarabine and cytarabine (FLUGA scheme) followed by maintenance with reduced doses (Mini-FLUGA) (standard treatment arm) versus subcutaneous azacitidine cycles (experimental treatment arm).
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 Evaluate the overall survival (OS) in one year treatment with 2 first-line regimens in newly diagnosed elderly patients: 3 cycles of induction chemotherapy based on fludarabine and cytarabine (FLUGA scheme) followed by maintenance with reduced doses(Mini-FLUGA) (standard treatment arm) versus subcutaneous azacitidine cycles (experimental treatment arm).
    Actual start date of recruitment
    28 Oct 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
    Spain: 283
    Worldwide total number of subjects
    283
    EEA total number of subjects
    283
    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)
    0
    From 65 to 84 years
    265
    85 years and over
    18

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period started on 28/10/2014 and ended on 28/10/2017. All patients were recruited in Spain.

    Pre-assignment
    Screening details
    		 A total of 329 potential subjects were screened after signing an informed consent form, of whom 283 subjects were randomized to receive study treatment.

    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
    		 fludarabine cytarabine
    Arm description
    		 Daily administration of subcutaneous G-CSF (lenograstim or filgrastim 5 mcg /kg / day, days -1, 1 and 2) (not given if hyperleukocytosis> 25 x 109/l), followed by: - Oral fludarabine (40 mg/m2/day, days 1 to 5) and subcutaneous cytarabine (75mg/m2/day, days 1 to 5) (FLUGA scheme) (fludarabine and cytarabine only days 1 to 4 if age ≥75 years), OR - Fludarabine (25 mg/m2/day) and cytarabine (75 mg/m2/day infusion of 6 hours) on their intravenous formulations if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fludarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion, Film-coated tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    - Oral fludarabine (40 mg/m2/day, days 1 to 5) (fludarabine only days 1 to 4 if age ≥75 years), OR - Fludarabine (25 mg/m2/day) on its intravenous formulations if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days

    Investigational medicinal product name
    Cytarabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use, Intracavernous use
    Dosage and administration details
    - Subcutaneous cytarabine (75mg/m2/day, days 1 to 5) (cytarabine only days 1 to 4 if age ≥75 years), OR - Cytarabine (75 mg/m2/day infusion of 6 hours) on its intravenous formulation if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days

    Arm title
    		 Azacitidine
    Arm description
    		 Subcutaneous Azacitidine 75 mg/m2/day, days 1 to 7. Treatment cycles every 28 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous Azacitidine 75 mg/m2/day, days 1 to 7. Treatment cycles every 28 days.

    Number of subjects in period 1
    		fludarabine cytarabine Azacitidine
    Started
    141
    142
    Completed
    25
    46
    Not completed
    116
    96
         Adverse event, serious fatal
    50
    47
         Consent withdrawn by subject
    6
    3
         Physician decision
    -
    2
         Adverse event, non-fatal
    9
    6
         Lost to follow-up
    1
    -
         Second neoplasm
    -
    1
         Lack of efficacy
    50
    37

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    fludarabine cytarabine
    Reporting group description
    		 Daily administration of subcutaneous G-CSF (lenograstim or filgrastim 5 mcg /kg / day, days -1, 1 and 2) (not given if hyperleukocytosis> 25 x 109/l), followed by: - Oral fludarabine (40 mg/m2/day, days 1 to 5) and subcutaneous cytarabine (75mg/m2/day, days 1 to 5) (FLUGA scheme) (fludarabine and cytarabine only days 1 to 4 if age ≥75 years), OR - Fludarabine (25 mg/m2/day) and cytarabine (75 mg/m2/day infusion of 6 hours) on their intravenous formulations if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days

    Reporting group title
    Azacitidine
    Reporting group description
    		 Subcutaneous Azacitidine 75 mg/m2/day, days 1 to 7. Treatment cycles every 28 days.

    Reporting group values
    		 fludarabine cytarabine Azacitidine Total
    Number of subjects
    		 141 142 283
    Age categorical
    Units: Subjects
        From 65-69 years
    		 26 23 49
        From 70-74 years
    		 35 49 84
        75 years and over
    		 80 70 150
    Age continuous
    Units: years
        median (full range (min-max))
    		 76 (65 to 88) 74 (65 to 90) -
    Gender categorical
    Units: Subjects
        Female
    		 62 57 119
        Male
    		 79 85 164
    ECOG PS
    Units: Subjects
        0 or 1
    		 114 105 219
        2 or 3
    		 26 36 62
        UNK
    		 1 1 2
    WBC x10^9/L
    Units: Subjects
        <15x10^9/L
    		 87 96 183
        15-50x10^9/L
    		 36 33 69
        >50x10^9/L
    		 18 13 31
    WBC x10^9/L
    Units: x10^9/L
        median (full range (min-max))
    		 7.9 (0.8 to 203.4) 4.5 (0.6 to 235.5) -

    End points

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    End points reporting groups
    Reporting group title
    fludarabine cytarabine
    Reporting group description
    		 Daily administration of subcutaneous G-CSF (lenograstim or filgrastim 5 mcg /kg / day, days -1, 1 and 2) (not given if hyperleukocytosis> 25 x 109/l), followed by: - Oral fludarabine (40 mg/m2/day, days 1 to 5) and subcutaneous cytarabine (75mg/m2/day, days 1 to 5) (FLUGA scheme) (fludarabine and cytarabine only days 1 to 4 if age ≥75 years), OR - Fludarabine (25 mg/m2/day) and cytarabine (75 mg/m2/day infusion of 6 hours) on their intravenous formulations if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days

    Reporting group title
    Azacitidine
    Reporting group description
    		 Subcutaneous Azacitidine 75 mg/m2/day, days 1 to 7. Treatment cycles every 28 days.

    Primary: Efficacy (overall survival (OS) attained without increasing the therapy-related toxicity or decreasing the patients QoL

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    End point title
    		 Efficacy (overall survival (OS) attained without increasing the therapy-related toxicity or decreasing the patients QoL
    End point description
    To evaluate the overall survival (OS) in one year treatment with 2 first-line regimens in newly diagnosed elderly patients: 3 cycles of induction chemotherapy based on fludarabine and cytarabine (FLUGA scheme) followed by maintenance with reduced doses(Mini-FLUGA) (standard treatment arm) versus subcutaneous azacitidine cycles (experimental treatment arm).
    End point type
    Primary
    End point timeframe
    1 year.
    End point values
    		 fludarabine cytarabine Azacitidine
    Number of subjects analysed
    141
    142
    Units: month
        number (confidence interval 95%)
    27 (20 to 34)
    47 (39 to 55)
    Statistical analysis title
    		 1-year OS between AZA and FLUGA regimens
    Statistical analysis description
    To analyze these variables, survival curves were estimated by Kaplan-Meier method and log-rank test was performed for comparison between groups.
    Comparison groups
    fludarabine cytarabine v Azacitidine
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Logrank
    Confidence interval

    Secondary: Efficacy Event free survival (EFS)

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    End point title
    		 Efficacy Event free survival (EFS)
    End point description
    Event free survival (EFS)
    End point type
    Secondary
    End point timeframe
    4 years
    End point values
    		 fludarabine cytarabine Azacitidine
    Number of subjects analysed
    141
    142
    Units: month
        median (confidence interval 95%)
    3 (2.5 to 3.5)
    4.9 (2.8 to 7)
    No statistical analyses for this end point

    Secondary: Efficacy (Duration of remission.)

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    End point title
    		 Efficacy (Duration of remission.)
    End point description
    Duration of remission.
    End point type
    Secondary
    End point timeframe
    4 years
    End point values
    		 fludarabine cytarabine Azacitidine
    Number of subjects analysed
    141
    142
    Units: month
        median (confidence interval 95%)
    9 (6.2 to 16.4)
    12.3 (9.8 to 17)
    No statistical analyses for this end point

    Secondary: Efficacy (Overall survival)

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    End point title
    		 Efficacy (Overall survival)
    End point description
    Overall survival
    End point type
    Secondary
    End point timeframe
    4 years
    End point values
    		 fludarabine cytarabine Azacitidine
    Number of subjects analysed
    141
    142
    Units: month
        median (confidence interval 95%)
    4.1 (2.7 to 5.5)
    9.8 (5.6 to 14)
    No statistical analyses for this end point

    Secondary: Safety (Compare hematologic and non-hematologic toxicity)

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    End point title
    		 Safety (Compare hematologic and non-hematologic toxicity)
    End point description
    Compare hematologic and non-hematologic toxicity in both arms (adverse events grades ≥3)
    End point type
    Secondary
    End point timeframe
    4 years
    End point values
    		 fludarabine cytarabine Azacitidine
    Number of subjects analysed
    141
    142
    Units: adverse events grade ≥ 3
    346
    311
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Fludarabine Cytarabine
    Reporting group description
    		 Daily administration of subcutaneous G-CSF (lenograstim or filgrastim 5 mcg /kg / day, days -1, 1 and 2) (not given if hyperleukocytosis> 25 x 109/l), followed by: - Oral fludarabine (40 mg/m2/day, days 1 to 5) and subcutaneous cytarabine (75mg/m2/day, days 1 to 5) (FLUGA scheme) (fludarabine and cytarabine only days 1 to 4 if age ≥75 years), OR - Fludarabine (25 mg/m2/day) and cytarabine (75 mg/m2/day infusion of 6 hours) on their intravenous formulations if the patient is hospitalized (patients with hyperleukocytosis or other unfavourable conditions). Treatment cycles every 28 days

    Reporting group title
    Azacitidine
    Reporting group description
    		 Subcutaneous Azacitidine 75 mg/m2/day, days 1 to 7. Treatment cycles every 28 days.

    Serious adverse events
    		 Fludarabine Cytarabine Azacitidine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    109 / 141 (77.30%)
    128 / 142 (90.14%)
         number of deaths (all causes)
    133
    127
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    multi-organ failure
         subjects affected / exposed
    3 / 141 (2.13%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Diarrhoea
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever
         subjects affected / exposed
    6 / 141 (4.26%)
    5 / 142 (3.52%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory
         subjects affected / exposed
    9 / 141 (6.38%)
    9 / 142 (6.34%)
         occurrences causally related to treatment / all
    3 / 9
    2 / 14
         deaths causally related to treatment / all
    1 / 6
    0 / 3
    Pneumonia
         subjects affected / exposed
    26 / 141 (18.44%)
    21 / 142 (14.79%)
         occurrences causally related to treatment / all
    12 / 32
    5 / 24
         deaths causally related to treatment / all
    3 / 9
    1 / 6
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Investigations
    Laboratory test abnormal
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 142 (2.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiological
         subjects affected / exposed
    5 / 141 (3.55%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neutropenia
         subjects affected / exposed
    4 / 141 (2.84%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 141 (2.84%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    40 / 141 (28.37%)
    30 / 142 (21.13%)
         occurrences causally related to treatment / all
    52 / 52
    43 / 43
         deaths causally related to treatment / all
    1 / 2
    0 / 2
    Hemorrhage
         subjects affected / exposed
    10 / 141 (7.09%)
    9 / 142 (6.34%)
         occurrences causally related to treatment / all
    6 / 14
    1 / 9
         deaths causally related to treatment / all
    3 / 5
    1 / 4
    Thrombotic
         subjects affected / exposed
    2 / 141 (1.42%)
    7 / 142 (4.93%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Splenomegaly
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Hepatic
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal
         subjects affected / exposed
    0 / 141 (0.00%)
    6 / 142 (4.23%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    8 / 141 (5.67%)
    14 / 142 (9.86%)
         occurrences causally related to treatment / all
    3 / 8
    4 / 18
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Sepsis
         subjects affected / exposed
    18 / 141 (12.77%)
    18 / 142 (12.68%)
         occurrences causally related to treatment / all
    14 / 21
    3 / 19
         deaths causally related to treatment / all
    2 / 5
    3 / 8
    Metabolism and nutrition disorders
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fludarabine Cytarabine Azacitidine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    125 / 141 (88.65%)
    108 / 142 (76.06%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Diarrhoea
         subjects affected / exposed
    3 / 141 (2.13%)
    0 / 142 (0.00%)
         occurrences all number
    3
    0
    Pain
         subjects affected / exposed
    3 / 141 (2.13%)
    4 / 142 (2.82%)
         occurrences all number
    4
    4
    Edema
         subjects affected / exposed
    2 / 141 (1.42%)
    1 / 142 (0.70%)
         occurrences all number
    2
    2
    Fever
         subjects affected / exposed
    6 / 141 (4.26%)
    4 / 142 (2.82%)
         occurrences all number
    7
    4
    Fatigue
         subjects affected / exposed
    10 / 141 (7.09%)
    7 / 142 (4.93%)
         occurrences all number
    10
    8
    General symptom
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Arthralgia
         subjects affected / exposed
    2 / 141 (1.42%)
    7 / 142 (4.93%)
         occurrences all number
    2
    7
    Transfusion reaction
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Respiratory
         subjects affected / exposed
    6 / 141 (4.26%)
    5 / 142 (3.52%)
         occurrences all number
    7
    5
    Pneumonia
         subjects affected / exposed
    9 / 141 (6.38%)
    6 / 142 (4.23%)
         occurrences all number
    9
    7
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 142 (1.41%)
         occurrences all number
    2
    2
    Investigations
    Laboratory test abnormal
         subjects affected / exposed
    6 / 141 (4.26%)
    6 / 142 (4.23%)
         occurrences all number
    6
    10
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    0
    3
    Cardiac disorders
    cardiological
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 142 (2.11%)
         occurrences all number
    1
    3
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    16 / 141 (11.35%)
    13 / 142 (9.15%)
         occurrences all number
    29
    14
    leukocytosis
         subjects affected / exposed
    3 / 141 (2.13%)
    0 / 142 (0.00%)
         occurrences all number
    3
    0
    Neutropenia
         subjects affected / exposed
    10 / 141 (7.09%)
    16 / 142 (11.27%)
         occurrences all number
    14
    23
    Thrombocytopenia
         subjects affected / exposed
    14 / 141 (9.93%)
    3 / 142 (2.11%)
         occurrences all number
    22
    7
    hemorrhage
         subjects affected / exposed
    4 / 141 (2.84%)
    2 / 142 (1.41%)
         occurrences all number
    4
    3
    thrombotic
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    Febrile neutropenia
         subjects affected / exposed
    12 / 141 (8.51%)
    6 / 142 (4.23%)
         occurrences all number
    16
    7
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Renal
         subjects affected / exposed
    3 / 141 (2.13%)
    2 / 142 (1.41%)
         occurrences all number
    3
    2
    Infections and infestations
    Infection
         subjects affected / exposed
    4 / 141 (2.84%)
    11 / 142 (7.75%)
         occurrences all number
    5
    16
    Sepsis
         subjects affected / exposed
    4 / 141 (2.84%)
    2 / 142 (1.41%)
         occurrences all number
    5
    3
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jun 2014
    Version 2 UPDATE CRF INCLUDING THE QUESTIONARY EQ-5D
    26 Oct 2016
    Version 3 THE TRIAL RECRUITMENT PERIOD WAS EXTENDED ONE YEAR

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33626197
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