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    Clinical Trial Results:
    A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2012-003214-13
    Trial protocol
    		 DE  
    Global end of trial date
    14 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2018
    First version publication date
    30 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4X-MC-JFCL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01769391
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14790
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center , Indianapolis, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    14 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2013
    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
    Russian Federation: 40
    Country: Number of subjects enrolled
    United States: 78
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 16
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Germany: 8
    Worldwide total number of subjects
    167
    EEA total number of subjects
    27
    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)
    75
    From 65 to 84 years
    90
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A completer is defined as having a complete radiographic assessment at baseline and at least one complete post-baseline radiographic assessment of CR, PR , SD or PD.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Necitumumab +Paclitaxel+Carboplatin
    Arm description
    		 Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

    Investigational medicinal product name
    Necitumumab
    Investigational medicinal product code
    Other name
    LY3012211, IMC-11F8
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin Area Under the Curve (AUC)6 milligrams times minute per milliliter (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

    Arm title
    		 Paclitaxel + Carboplatin
    Arm description
    		 Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin Area Under the Curve (AUC)6 milligrams times minute per milliliter (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

    Number of subjects in period 1
    		Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin
    Started
    110
    57
    Received at Least One Dose of Study Drug
    106
    55
    Completed
    93
    48
    Not completed
    17
    9
         Adverse event, serious fatal
    10
    1
         Consent withdrawn by subject
    4
    3
         Adverse event, non-fatal
    -
    3
         Progressive Disease
    1
    2
         Investigator Decision
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Necitumumab +Paclitaxel+Carboplatin
    Reporting group description
    		 Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

    Reporting group title
    Paclitaxel + Carboplatin
    Reporting group description
    		 Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

    Reporting group values
    		 Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin Total
    Number of subjects
    		 110 57 167
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 48 27 75
        From 65-84 years
    		 61 29 90
        85 years and over
    		 1 1 2
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.5 ( 9.36 ) 64.7 ( 8.27 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 23 13 36
        Male
    		 87 44 131
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 4 7
        Not Hispanic or Latino
    		 105 53 158
        Unknown or Not Reported
    		 2 0 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 2 2
        Asian
    		 10 6 16
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 2 5
        White
    		 97 47 144
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Russian Federation
    		 28 12 40
        United States
    		 53 25 78
        Poland
    		 12 7 19
        Korea, Republic of
    		 10 6 16
        Mexico
    		 3 3 6
        Germany
    		 4 4 8

    End points

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    End points reporting groups
    Reporting group title
    Necitumumab +Paclitaxel+Carboplatin
    Reporting group description
    		 Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

    Reporting group title
    Paclitaxel + Carboplatin
    Reporting group description
    		 Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.

    Subject analysis set title
    Necitumumab + Paclitaxel+ Carboplatin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.

    Primary: Percentage of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])

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    End point title
    		 Percentage of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
    End point description
    The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    End point type
    Primary
    End point timeframe
    Baseline to Disease Progression or Death (Up to 24 Months)
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin
    Number of subjects analysed
    94 [1]
    50 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    48.9 (38.5 to 59.5)
    40.0 (26.4 to 54.8)
    Notes
    [1] - Participants who had study drug,1 pre and post radiographic assessment.
    [2] - Participants who had study drug,1 pre and post radiographic assessment.
    Statistical analysis title
    		 Statistical Analysis Overall Response Rate
    Statistical analysis description
    The denominator of ORR includes each patient randomized (for the particular treatment arm, or subgroup being analyzed) who received at least one dose of the assigned study drug and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those patients counted in the denominator with a best overall tumor response of PR or CR.
    Comparison groups
    Necitumumab +Paclitaxel+Carboplatin v Paclitaxel + Carboplatin
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    57.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 37.03
         upper limit
    		 57.88

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).
    End point type
    Secondary
    End point timeframe
    Randomization to Date of Death (Up to 24 Months)
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin
    Number of subjects analysed
    110 [3]
    57 [4]
    Units: months
        median (confidence interval 95%)
    13.2 (9.7 to 15.9)
    11.2 (8.2 to 12.7)
    Notes
    [3] - All randomized participants.
    [4] - All randomized participants.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab

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    End point title
    		 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Serum concentrations of necitumumab at each sampling time point were summarized using descriptive statistics
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin
    Number of subjects analysed
    92 [6]
    Units: microgram/milliliter (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1, Day 1 (n=92)
    262.418 ( 32.84 )
        Cycle 3, Day 1 (n=72)
    296.843 ( 62.97 )
        Cycle 5, Day 1 (n=62)
    303.475 ( 53.75 )
    Notes
    [6] - All participants who received at least one dose of necitumumab and had evaluable PK data.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti Necitumumab Antibodies

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    End point title
    		 Percentage of Participants with Anti Necitumumab Antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to End of Cycle 6
    End point values
    		 Necitumumab + Paclitaxel+ Carboplatin
    Number of subjects analysed
    106 [7]
    Units: percentage of participants
        number (not applicable)
    2.8
    Notes
    [7] - All participants who received any amount of necitumumab and had post baseline antibody data.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival

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    End point title
    		 Progression-Free Survival
    End point description
    Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.
    End point type
    Secondary
    End point timeframe
    Randomization to Progressive Disease or Death (Up to 24 Months)
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin
    Number of subjects analysed
    110 [8]
    57 [9]
    Units: months
        median (confidence interval 95%)
    5.4 (4.2 to 5.7)
    5.6 (4.3 to 6.8)
    Notes
    [8] - All randomized participants.
    [9] - All randomized participants.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

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    End point title
    		 Percentage of Participants who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
    End point description
    Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).
    End point type
    Secondary
    End point timeframe
    Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin
    Number of subjects analysed
    94 [10]
    50
    Units: percentage of participants
        number (confidence interval 95%)
    87.2 (78.8 to 93.2)
    84.0 (70.9 to 92.8)
    Notes
    [10] - Randomized participants who received 1 dose of study drug a complete radiographic assessment.
    No statistical analyses for this end point

    Secondary: Percent Change in Tumor Size (CTS)

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    End point title
    		 Percent Change in Tumor Size (CTS)
    End point description
    CTS is defined as maximum percent change from baseline in the sum of target lesions.
    End point type
    Secondary
    End point timeframe
    Baseline to Progressive Disease or Death (Up to 24 Months)
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin Paclitaxel + Carboplatin
    Number of subjects analysed
    83 [11]
    43 [12]
    Units: percent change in tumor size
        arithmetic mean (standard deviation)
    -44.3 ( 22.8 )
    -38.65 ( 24.4 )
    Notes
    [11] - Randomized participants who received 1 dose of study drug and had a radiographic assessment.
    [12] - Randomized participants who received 1 dose of study drug and had a radiographic assessment.
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

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    End point title
    		 Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab [13]
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Serum concentrations of necitumumab at each sampling time point were summarized using descriptive statistics
    End point values
    		 Necitumumab +Paclitaxel+Carboplatin
    Number of subjects analysed
    92 [14]
    Units: nanogram/milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1, Day 8 (n-85)
    59.269 ( 59.06 )
        Cycle 2, Day 1 (n=79)
    47.874 ( 79.89 )
        Cycle 3, Day 1 (n=76)
    78.142 ( 70.99 )
        Cycle 4, Day 1 (n=70)
    80.392 ( 74.42 )
        Cycle 5, Day 1 (n=62)
    89.137 ( 88.94 )
        Cycle 6, Day 1 (n=59)
    87.043 ( 85.02 )
    Notes
    [14] - Participants who received 1 dose of study drug and had evaluable PK data.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I4X-MC-JFCL
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Necitumumab + Paclitaxel + Carboplatin
    Reporting group description
    		 -

    Reporting group title
    Paclitaxel + Carboplatin
    Reporting group description
    		 -

    Serious adverse events
    		 Necitumumab + Paclitaxel + Carboplatin Paclitaxel + Carboplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    43 / 106 (40.57%)
    21 / 55 (38.18%)
         number of deaths (all causes)
    12
    4
         number of deaths resulting from adverse events
    3
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    malignant neoplasm progression
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malignant pleural effusion
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    circulatory collapse
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhage
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypovolaemic shock
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 106 (4.72%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    10 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    brain death
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    death
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    mucosal inflammation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    systemic inflammatory response syndrome
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    bronchial obstruction
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cough
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 106 (4.72%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    epistaxis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemoptysis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypoxia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    interstitial lung disease
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax spontaneous
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    pulmonary haemorrhage
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Psychiatric disorders
    delirium
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    neutrophil count decreased
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thermal burn
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    4 / 106 (3.77%)
    4 / 55 (7.27%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 55 (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
    cerebral ischaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depressed level of consciousness
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    encephalopathy
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    loss of consciousness
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neuropathy peripheral
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 106 (4.72%)
    4 / 55 (7.27%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anaemia of chronic disease
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    5 / 7
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 106 (4.72%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    3 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dysphagia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer haemorrhage
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ileus
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stomatitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscular weakness
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    bacterial sepsis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clostridium difficile colitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    herpes simplex
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lung infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    perirectal abscess
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    14 / 106 (13.21%)
    4 / 55 (7.27%)
         occurrences causally related to treatment / all
    3 / 15
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    pneumonia bacterial
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia viral
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 106 (2.83%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    septic shock
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (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
    dehydration
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 106 (2.83%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypocalcaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypomagnesaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Necitumumab + Paclitaxel + Carboplatin Paclitaxel + Carboplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 106 (96.23%)
    49 / 55 (89.09%)
    Vascular disorders
    hypotension
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    12 / 106 (11.32%)
    7 / 55 (12.73%)
         occurrences all number
    13
    10
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    18 / 106 (16.98%)
    3 / 55 (5.45%)
         occurrences all number
    31
    5
    fatigue
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    33 / 106 (31.13%)
    24 / 55 (43.64%)
         occurrences all number
    52
    48
    non-cardiac chest pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    1 / 55 (1.82%)
         occurrences all number
    8
    1
    oedema peripheral
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    11 / 106 (10.38%)
    7 / 55 (12.73%)
         occurrences all number
    15
    9
    pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    0 / 55 (0.00%)
         occurrences all number
    9
    0
    pyrexia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    10 / 106 (9.43%)
    4 / 55 (7.27%)
         occurrences all number
    16
    5
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    18 / 106 (16.98%)
    10 / 55 (18.18%)
         occurrences all number
    24
    10
    dysphonia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    4 / 106 (3.77%)
    3 / 55 (5.45%)
         occurrences all number
    5
    4
    dyspnoea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    23 / 106 (21.70%)
    6 / 55 (10.91%)
         occurrences all number
    29
    13
    dyspnoea exertional
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 106 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    0
    4
    epistaxis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    haemoptysis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    6 / 55 (10.91%)
         occurrences all number
    7
    8
    nasal congestion
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    4 / 106 (3.77%)
    3 / 55 (5.45%)
         occurrences all number
    6
    3
    oropharyngeal pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 106 (2.83%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    productive cough
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    3 / 55 (5.45%)
         occurrences all number
    1
    4
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    6 / 106 (5.66%)
    0 / 55 (0.00%)
         occurrences all number
    6
    0
    insomnia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    14 / 106 (13.21%)
    6 / 55 (10.91%)
         occurrences all number
    16
    7
    Investigations
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    0 / 55 (0.00%)
         occurrences all number
    9
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    6 / 55 (10.91%)
         occurrences all number
    18
    7
    weight decreased
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    31 / 106 (29.25%)
    14 / 55 (25.45%)
         occurrences all number
    49
    20
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 55 (5.45%)
         occurrences all number
    2
    4
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    14 / 106 (13.21%)
    8 / 55 (14.55%)
         occurrences all number
    16
    10
    dysgeusia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    4 / 55 (7.27%)
         occurrences all number
    10
    4
    headache
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    4 / 106 (3.77%)
    7 / 55 (12.73%)
         occurrences all number
    6
    7
    neuropathy peripheral
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    13 / 106 (12.26%)
    9 / 55 (16.36%)
         occurrences all number
    21
    18
    paraesthesia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 106 (2.83%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    31 / 106 (29.25%)
    13 / 55 (23.64%)
         occurrences all number
    54
    24
    syncope
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    1 / 55 (1.82%)
         occurrences all number
    8
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    34 / 106 (32.08%)
    27 / 55 (49.09%)
         occurrences all number
    87
    62
    leukopenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    9 / 106 (8.49%)
    9 / 55 (16.36%)
         occurrences all number
    16
    15
    neutropenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    37 / 106 (34.91%)
    16 / 55 (29.09%)
         occurrences all number
    73
    43
    thrombocytopenia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    27 / 106 (25.47%)
    14 / 55 (25.45%)
         occurrences all number
    67
    31
    Eye disorders
    vision blurred
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    2 / 106 (1.89%)
    3 / 55 (5.45%)
         occurrences all number
    2
    3
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    2 / 55 (3.64%)
         occurrences all number
    11
    2
    constipation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    25 / 106 (23.58%)
    15 / 55 (27.27%)
         occurrences all number
    28
    23
    diarrhoea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    26 / 106 (24.53%)
    12 / 55 (21.82%)
         occurrences all number
    34
    18
    dyspepsia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    6 / 106 (5.66%)
    3 / 55 (5.45%)
         occurrences all number
    6
    3
    nausea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    27 / 106 (25.47%)
    20 / 55 (36.36%)
         occurrences all number
    35
    34
    stomatitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    14 / 106 (13.21%)
    3 / 55 (5.45%)
         occurrences all number
    15
    3
    vomiting
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    13 / 106 (12.26%)
    8 / 55 (14.55%)
         occurrences all number
    17
    11
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    28 / 106 (26.42%)
    10 / 55 (18.18%)
         occurrences all number
    30
    11
    dermatitis acneiform
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    23 / 106 (21.70%)
    0 / 55 (0.00%)
         occurrences all number
    40
    0
    dry skin
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    13 / 106 (12.26%)
    1 / 55 (1.82%)
         occurrences all number
    13
    1
    pruritus
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    6 / 106 (5.66%)
    0 / 55 (0.00%)
         occurrences all number
    6
    0
    rash
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    22 / 106 (20.75%)
    1 / 55 (1.82%)
         occurrences all number
    69
    1
    rash maculo-papular
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    0 / 55 (0.00%)
         occurrences all number
    17
    0
    rash papular
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    12 / 106 (11.32%)
    0 / 55 (0.00%)
         occurrences all number
    16
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    24 / 106 (22.64%)
    13 / 55 (23.64%)
         occurrences all number
    61
    29
    back pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    10 / 106 (9.43%)
    3 / 55 (5.45%)
         occurrences all number
    11
    3
    bone pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    8 / 55 (14.55%)
         occurrences all number
    10
    14
    muscular weakness
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    10 / 106 (9.43%)
    4 / 55 (7.27%)
         occurrences all number
    10
    7
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 106 (0.94%)
    7 / 55 (12.73%)
         occurrences all number
    1
    9
    musculoskeletal pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 106 (2.83%)
    4 / 55 (7.27%)
         occurrences all number
    5
    7
    myalgia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    18 / 106 (16.98%)
    12 / 55 (21.82%)
         occurrences all number
    44
    21
    pain in extremity
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    8 / 106 (7.55%)
    8 / 55 (14.55%)
         occurrences all number
    10
    8
    Infections and infestations
    conjunctivitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    0 / 55 (0.00%)
         occurrences all number
    9
    0
    paronychia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    6 / 106 (5.66%)
    0 / 55 (0.00%)
         occurrences all number
    9
    0
    pneumonia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    6 / 106 (5.66%)
    2 / 55 (3.64%)
         occurrences all number
    9
    2
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    34 / 106 (32.08%)
    15 / 55 (27.27%)
         occurrences all number
    40
    20
    dehydration
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    11 / 106 (10.38%)
    10 / 55 (18.18%)
         occurrences all number
    15
    17
    hypoalbuminaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    5 / 106 (4.72%)
    3 / 55 (5.45%)
         occurrences all number
    9
    4
    hypocalcaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    10 / 106 (9.43%)
    2 / 55 (3.64%)
         occurrences all number
    19
    2
    hypokalaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    14 / 106 (13.21%)
    4 / 55 (7.27%)
         occurrences all number
    28
    7
    hypomagnesaemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    25 / 106 (23.58%)
    7 / 55 (12.73%)
         occurrences all number
    74
    12
    hyponatraemia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    7 / 106 (6.60%)
    1 / 55 (1.82%)
         occurrences all number
    13
    1

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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