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    Clinical Trial Results:
    Pazopanib with 5-Flourouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line treatment in advanced gastric cancer; a randomized Phase II study. - The PaFLO study.

    Summary
    EudraCT number
    		 2010-024379-15
    Trial protocol
    		 DE  
    Global end of trial date
    19 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2022
    First version publication date
    28 Apr 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PaFLO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01503372
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - University Hospital of Berlin
    Sponsor organisation address
    Augustenburger Platz 1, Berlin, Germany, 13353
    Public contact
    Dr. Peter Thuß-Patience, Charité - Universitätsmedizin Berlin, 49 30450653193, peter.thuss@charite.de
    Scientific contact
    Dr. Peter Thuß-Patience, Charité - Universitätsmedizin Berlin, 49 30450653193, peter.thuss@charite.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
    19 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    progression free survival rate at 6 months
    Protection of trial subjects
    Inclusion and exlusion criteria were implemented to protect the patients.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2011
    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
    Germany: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    78
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients from 20 national clinical centers were included and between December 2011 and July 2014, 87 patients were enrolled.

    Pre-assignment
    Screening details
    		 87 Patients were screened And 9 Patients were excluded.

    Period 1
    Period 1 title
    Treatment phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PaFLO Group
    Arm description
    		 Medication (FLO) on day one every 2 weeks for 12 cycles and pazopanib once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pazopanib
    Investigational medicinal product code
    GW786034
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800mg once a day

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    5-FU
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU was administered with 2600 mg/m2 over 24 hours

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    oxaliplatin 85 mg/m² over 2 hours on day one every 2 weeks for 12 cycles

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Leucovorin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    leucovorine 200 mg/m² over 2 hours

    Arm title
    		 FLO Group
    Arm description
    		 Medication on day one every 2 weeks for 12 cycles
    Arm type
    		 Active comparator

    Investigational medicinal product name
    5-FU
    Investigational medicinal product code
    5-FU
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-FU was administered with 2600 mg/m² over 24 hours

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    oxaliplatin 85 mg/m² over 2 hours

    Investigational medicinal product name
    Folinic acid
    Investigational medicinal product code
    Other name
    Leucovorin
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    leucovorine 200 mg/m² over 2 hours

    Number of subjects in period 1
    		PaFLO Group FLO Group
    Started
    51
    27
    Completed
    51
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PaFLO Group
    Reporting group description
    		 Medication (FLO) on day one every 2 weeks for 12 cycles and pazopanib once daily

    Reporting group title
    FLO Group
    Reporting group description
    		 Medication on day one every 2 weeks for 12 cycles

    Reporting group values
    		 PaFLO Group FLO Group Total
    Number of subjects
    		 51 27 78
    Age categorical
    Units: Subjects
        Adults >= 18
    		 51 27 78
    Gender categorical
    Units: Subjects
        Female
    		 14 10 24
        Male
    		 37 17 54
    ECOG
    Eastern Cooperative Oncology Group (ECOG) system
    Units: Subjects
        status 0
    		 22 12 34
        status 1
    		 26 13 39
        status 2
    		 3 2 5
    Site of tumor
    AEG, adenocarcinoma of the esophago-gastric junction
    Units: Subjects
        AEG
    		 30 8 38
        Stomach
    		 21 19 40
    Histological type (Laurén)
    Units: Subjects
        Intestinal
    		 15 9 24
        Diffuse
    		 8 6 14
        Mixed
    		 6 1 7
        Not specified
    		 19 10 29
        N/A
    		 3 1 4
    WHO classification
    Units: Subjects
        Mucinous
    		 1 1 2
        Tubular
    		 6 3 9
        Signet ring cells
    		 9 8 17
        Not specified
    		 26 12 38
        N/A
    		 9 3 12
    Clinical stage (T), UICC version 7.0
    Units: Subjects
        T0
    		 1 0 1
        uT1
    		 5 1 6
        uT2
    		 3 0 3
        uT3
    		 14 11 25
        uT4
    		 10 4 14
        uT4a
    		 1 1 2
        Tx
    		 13 8 21
        N/A
    		 4 2 6
    Metastatic spread (M), UICC version 7.0
    Units: Subjects
        M0
    		 3 0 3
        M1
    		 48 27 75
    No. organs involved
    Units: Subjects
        1 Organ
    		 1 2 3
        2 Organs
    		 14 11 25
        >=3 Organs
    		 36 14 50
    Local recurrence
    Units: Subjects
        Yes
    		 9 5 14
        No
    		 42 22 64

    End points

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    End points reporting groups
    Reporting group title
    PaFLO Group
    Reporting group description
    		 Medication (FLO) on day one every 2 weeks for 12 cycles and pazopanib once daily

    Reporting group title
    FLO Group
    Reporting group description
    		 Medication on day one every 2 weeks for 12 cycles

    Primary: Progression-free survival during treatment

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    End point title
    		 Progression-free survival during treatment
    End point description
    For the Kaplan-Meier curve of progression-free survival see attachment PFS curve
    End point type
    Primary
    End point timeframe
    at 6 months
    End point values
    		 PaFLO Group FLO Group
    Number of subjects analysed
    51
    27
    Units: months
    number (not applicable)
        Median FPS
    4.66
    4.47
    Attachments
    		 PFS curve
    Statistical analysis title
    		 exploratory comparisons
    Comparison groups
    PaFLO Group v FLO Group
    Number of subjects included in analysis
    78
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.05 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.55
    Notes
    [1] - The FLO arm served as internal control as calibration arm without preplanned comparisons between the two arms. Therefore, all comparisons are of exploratory nature. The estimation of survival rates was performed according to Kaplan-Meier analysis. Statistical comparison analysis applied the log-rank test and the proportional hazard model.
    [2] - All tests are two-sided following the 5% level of significance using SPSS 27.0

    Primary: The rate of patients without progression at 6 months

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    End point title
    		 The rate of patients without progression at 6 months
    End point description
    The median OS was numerically higher in the PaFLO arm compared to FLO (10.19 months vs 7.33 months). Despite these promising signs of efficacy of adding pazopanib, when comparing other efficacy parameters to the internal control arm this benefit seems to be small.
    End point type
    Primary
    End point timeframe
    At 6 months
    End point values
    		 PaFLO Group FLO Group
    Number of subjects analysed
    51
    27
    Units: percent
    number (not applicable)
        PFS rate
    34
    30
    Statistical analysis title
    		 Effectivity and tolerability
    Statistical analysis description
    The FLO arm served as internal control as calibration arm without preplanned comparisons between the two arms. Therefore, all comparisons are of exploratory nature. The estimation of survival rates was performed according to Kaplan-Meier analysis.
    Comparison groups
    PaFLO Group v FLO Group
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [3]
    Method
    		 Logrank
    Confidence interval
    Notes
    [3] - All tests are two-sided following the 5% level of significance using SPSS 27.0

    Secondary: Overall survival during treatment

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    End point title
    		 Overall survival during treatment
    End point description
    End point type
    Secondary
    End point timeframe
    6-12 months
    End point values
    		 PaFLO Group FLO Group
    Number of subjects analysed
    51
    27
    Units: months
    number (not applicable)
        Median OS
    10.19
    7.33
    No statistical analyses for this end point

    Secondary: Best response confirmed after 12 months

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    End point title
    		 Best response confirmed after 12 months
    End point description
    Abbreviations: CR, complete response; DCR, disease control rate; FLO, 5-fluorouracil, folinic acid, oxaliplatin; ORR, overall response rate; PaFLO, pazopanib plus 5-fluorouracil, folinic acid, oxaliplatin; PR, partial response; SD, stable disease.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 PaFLO Group FLO Group
    Number of subjects analysed
    51
    27
    Units: Subjects
        CR
    1
    1
        PR
    12
    6
        SD
    24
    9
        PD
    9
    9
        DCR (CR + PR + SD)
    37
    16
        ORR (CR + PR)
    13
    7
    No statistical analyses for this end point

    Secondary: Toxicity

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    End point title
    		 Toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 PaFLO Group FLO Group
    Number of subjects analysed
    51
    27
    Units: Subject
        Leucopenia Grade 0
    35
    24
        Leucopenia Grade 1
    4
    2
        Leucopenia Grade 2
    9
    1
        Leucopenia Grade 3
    3
    0
        Leucopenia Grade 4
    0
    0
        Neutropenia Grade 0
    31
    24
        Neutropenia Grade 1
    5
    2
        Neutropenia Grade 2
    3
    0
        Neutropenia Grade 3
    11
    1
        Neutropenia Grade 4
    1
    0
        Thrombocytopenia Grade 0
    36
    23
        Thrombocytopenia Grade 1
    11
    3
        Thrombocytopenia Grade 2
    3
    1
        Thrombocytopenia Grade 3
    1
    0
        Thrombocytopenia Grade 4
    0
    0
        Anemia Grade 0
    36
    19
        Anemia Grade 1
    6
    5
        Anemia Grade 2
    8
    0
        Anemia Grade 3
    1
    3
        Anemia Grade 4
    0
    0
        Fever Grade 0
    42
    25
        Fever Grade 1
    5
    1
        Fever Grade 2
    0
    1
        Fever Grade 3
    4
    0
        Fever Grade 4
    0
    0
        Nausea Grade 0
    16
    10
        Nausea Grade 1
    19
    11
        Nausea Grade 2
    8
    6
        Nausea Grade 3
    8
    0
        Nausea Grade 4
    0
    0
        Loss of appetite Grade 0
    23
    14
        Loss of appetite Grade 1
    17
    4
        Loss of appetite Grade 2
    6
    7
        Loss of appetite Grade 3
    4
    0
        Loss of appetite Grade 4
    0
    2
        Vomiting Grade 0
    27
    15
        Vomiting Grade 1
    16
    5
        Vomiting Grade 2
    5
    5
        Vomiting Grade 3
    3
    2
        Vomiting Grade 4
    0
    0
        Diarrhea Grade 0
    23
    16
        Diarrhea Grade 1
    21
    7
        Diarrhea Grade 2
    8
    2
        Diarrhea Grade 3
    1
    2
        Diarrhea Grade 4
    0
    0
        Obstipation Grade 0
    31
    20
        Obstipation Grade 1
    19
    4
        Obstipation Grade 2
    1
    3
        Obstipation Grade 3
    0
    0
        Obstipation Grade 4
    0
    0
        Mucositis Grade 0
    39
    22
        Mucositis Grade 1
    10
    4
        Mucositis Grade 2
    2
    1
        Mucositis Grade 3
    0
    0
        Mucositis Grade 4
    0
    0
        Fatigue Grade 0
    24
    14
        Fatigue Grade 1
    15
    6
        Fatigue Grade 2
    8
    6
        Fatigue Grade 3
    4
    0
        Fatigue Grade 4
    0
    1
        Alopecia Grade 0
    33
    22
        Alopecia Grade 1
    13
    3
        Alopecia Grade 2
    0
    1
        Alopecia Grade 3
    0
    1
        Alopecia Grade 4
    0
    0
        Alteration of nails Grade 0
    43
    26
        Alteration of nails Grade 1
    8
    1
        Alteration of nails Grade 2
    0
    0
        Alteration of nails Grade 3
    0
    0
        Alteration of nails Grade 4
    0
    0
        Hand-foot syndrome Grade 0
    40
    25
        Hand-foot syndrome Grade 1
    8
    2
        Hand-foot syndrome Grade 2
    2
    0
        Hand-foot syndrome Grade 3
    1
    0
        Hand-foot syndrome Grade 4
    0
    0
        Change in taste Grade 0
    34
    23
        Change in taste Grade 1
    13
    3
        Change in taste Grade 2
    4
    1
        Change in taste Grade 3
    0
    0
        Change in taste Grade 4
    0
    0
        Vision disorders Grade 0
    45
    24
        Vision disorders Grade 1
    5
    2
        Vision disorders Grade 2
    1
    1
        Vision disorders Grade 3
    0
    0
        Vision disorders Grade 4
    0
    0
        Hearing impairment Grade 0
    49
    27
        Hearing impairment Grade 1
    2
    0
        Hearing impairment Grade 2
    0
    0
        Hearing impairment Grade 3
    0
    0
        Hearing impairment Grade 4
    0
    0
        Peripheral neuropathy Grade 0
    13
    9
        Peripheral neuropathy Grade 1
    22
    9
        Peripheral neuropathy Grade 2
    12
    7
        Peripheral neuropathy Grade 3
    3
    2
        Peripheral neuropathy Grade 4
    1
    0
        Vertigo Grade 0
    41
    24
        Vertigo Grade 1
    7
    2
        Vertigo Grade 2
    3
    1
        Vertigo Grade 3
    0
    0
        Vertigo Grade 4
    0
    0
        ALT Grade 0
    42
    26
        ALT Grade 1
    3
    1
        ALT Grade 2
    1
    0
        ALT Grade 3
    5
    0
        ALT Grade 4
    0
    0
        AST Grade 0
    43
    25
        AST Grade 1
    3
    2
        AST Grade 2
    1
    0
        AST Grade 3
    4
    0
        AST Grade 4
    0
    0
        Increase of creatinine Grade 0
    49
    26
        Increase of creatinine Grade 1
    2
    1
        Increase of creatinine Grade 2
    0
    0
        Increase of creatinine Grade 3
    0
    0
        Increase of creatinine Grade 4
    0
    0
        Bilirubin direct Grade 0
    42
    23
        Bilirubin direct Grade 1
    2
    0
        Bilirubin direct Grade 2
    0
    0
        Bilirubin direct Grade 3
    1
    0
        Bilirubin direct Grade 4
    0
    0
        Bilirubin total Grade 0
    47
    27
        Bilirubin total Grade 1
    1
    0
        Bilirubin total Grade 2
    1
    0
        Bilirubin total Grade 3
    2
    0
        Bilirubin total Grade 4
    0
    0
    No statistical analyses for this end point

    Secondary: Patients with PFS at 9 and 12 months

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    End point title
    		 Patients with PFS at 9 and 12 months
    End point description
    PFS:The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.
    End point type
    Secondary
    End point timeframe
    6 to 9 months
    End point values
    		 PaFLO Group FLO Group
    Number of subjects analysed
    51
    27
    Units: percent
    number (not applicable)
        After 9 months
    27
    18
        After 12 months
    4
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 months
    Adverse event reporting additional description
    non-serious AEs were Grade 1 and 2 serious AE were Grade 3 and 4
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    PaFLO
    Reporting group description
    		 -

    Reporting group title
    FLO-Group
    Reporting group description
    		 -

    Serious adverse events
    		 PaFLO FLO-Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 51 (23.53%)
    3 / 27 (11.11%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    ALT
    Additional description: Alanin-Amino-Transferase
         subjects affected / exposed
    5 / 51 (9.80%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AST
    Additional description: Aspartat-AminoTransferase
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bilirubin direct
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bilirubin total
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Peripheral neuropathy
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leucopenia
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    12 / 51 (23.53%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 27 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
         subjects affected / exposed
    8 / 51 (15.69%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhea
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    4 / 51 (7.84%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 27 (3.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot syndrome
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 27 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Loss of appetite
         subjects affected / exposed
    5 / 51 (9.80%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 27 (7.41%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PaFLO FLO-Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 51 (100.00%)
    27 / 27 (100.00%)
    Investigations
    ALT
    Additional description: Alanin-Amino-Transferase
         subjects affected / exposed
    4 / 51 (7.84%)
    1 / 27 (3.70%)
         occurrences all number
    4
    1
    AST
    Additional description: Aspartat-AminoTransferase
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 27 (7.41%)
         occurrences all number
    4
    2
    Increase of creatinine
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Bilirubin direct
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 27 (3.70%)
         occurrences all number
    2
    1
    Bilirubin total
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Change in taste
         subjects affected / exposed
    17 / 51 (33.33%)
    4 / 27 (14.81%)
         occurrences all number
    17
    4
    Peripheral neuropathy
         subjects affected / exposed
    34 / 51 (66.67%)
    16 / 27 (59.26%)
         occurrences all number
    34
    16
    Blood and lymphatic system disorders
    Leucopenia
         subjects affected / exposed
    13 / 51 (25.49%)
    3 / 27 (11.11%)
         occurrences all number
    13
    3
    Neutropenia
         subjects affected / exposed
    8 / 51 (15.69%)
    2 / 27 (7.41%)
         occurrences all number
    8
    2
    Thrombocytopenia
         subjects affected / exposed
    14 / 51 (27.45%)
    4 / 27 (14.81%)
         occurrences all number
    14
    4
    Anemia
         subjects affected / exposed
    14 / 51 (27.45%)
    5 / 27 (18.52%)
         occurrences all number
    14
    5
    General disorders and administration site conditions
    Fever
         subjects affected / exposed
    5 / 51 (9.80%)
    2 / 27 (7.41%)
         occurrences all number
    5
    2
    Nausea
         subjects affected / exposed
    27 / 51 (52.94%)
    17 / 27 (62.96%)
         occurrences all number
    27
    17
    Mucositis
         subjects affected / exposed
    12 / 51 (23.53%)
    5 / 27 (18.52%)
         occurrences all number
    12
    5
    Fatigue
         subjects affected / exposed
    23 / 51 (45.10%)
    12 / 27 (44.44%)
         occurrences all number
    23
    12
    Alteration of nails
         subjects affected / exposed
    8 / 51 (15.69%)
    1 / 27 (3.70%)
         occurrences all number
    8
    1
    Ear and labyrinth disorders
    Hearing impairment
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 27 (0.00%)
         occurrences all number
    2
    0
    Vertigo
         subjects affected / exposed
    10 / 51 (19.61%)
    3 / 27 (11.11%)
         occurrences all number
    10
    3
    Eye disorders
    Vision disorders
         subjects affected / exposed
    6 / 51 (11.76%)
    3 / 27 (11.11%)
         occurrences all number
    6
    3
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    29 / 51 (56.86%)
    9 / 27 (33.33%)
         occurrences all number
    29
    9
    Obstipation
         subjects affected / exposed
    20 / 51 (39.22%)
    7 / 27 (25.93%)
         occurrences all number
    20
    7
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    18 / 51 (35.29%)
    4 / 27 (14.81%)
         occurrences all number
    18
    4
    Hand-foot syndrome
         subjects affected / exposed
    10 / 51 (19.61%)
    2 / 27 (7.41%)
         occurrences all number
    10
    2
    Metabolism and nutrition disorders
    Loss of appetite
         subjects affected / exposed
    23 / 51 (45.10%)
    11 / 27 (40.74%)
         occurrences all number
    23
    11
    Vomiting
         subjects affected / exposed
    21 / 51 (41.18%)
    10 / 27 (37.04%)
         occurrences all number
    21
    10

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34741530
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