Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Single-Arm, Multicenter, Open-Label, Phase 2 Study of nab®-Paclitaxel (Abraxane®) and Carboplatin Chemotherapy plus Necitumumab (LY3012211) in the First-Line Treatment of Patients with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2016-002071-96
    Trial protocol
    		 ES   DE   GR  
    Global end of trial date
    06 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Nov 2020
    First version publication date
    15 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I4X-MC-JFCP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02392507
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15529
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, 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
    06 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus necitumumab is effective and safe in participants with stage IV squamous non-small cell lung cancer.
    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
    12 Oct 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 21 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 15
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    Greece: 8
    Worldwide total number of subjects
    54
    EEA total number of subjects
    39
    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)
    27
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants with known best overall response and off study treatment were considered to be completed.

    Period 1
    Period 1 title
    Induction Regimen
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Necitumumab + Nab-paclitaxel + Carboplatin
    Arm description
    		 Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Necitumumab
    Investigational medicinal product code
    LY3012211
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles).

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles.

    Number of subjects in period 1
    		Necitumumab + Nab-paclitaxel + Carboplatin
    Started
    54
    Received at Least 1 Dose of Study Drug
    54
    Completed
    47
    Not completed
    7
         Adverse event, serious fatal
    3
         Physician decision
    1
         Consent withdrawn by subject
    2
         On Study Treatment at Study Conclusion
    1
    Period 2
    Period 2 title
    Maintenance Regimen
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Necitumumab + Nab-paclitaxel
    Arm description
    		 Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Necitumumab
    Investigational medicinal product code
    LY3012211
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle.

    Investigational medicinal product name
    Nab-Paclitaxel
    Investigational medicinal product code
    Other name
    Abraxane
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle.

    Number of subjects in period 2 [1]
    		Necitumumab + Nab-paclitaxel
    Started
    34
    Completed
    32
    Not completed
    2
         Adverse event, serious fatal
    1
         On Study Treatment at Study Conclusion
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: After induction regimen participants with disease response are eligible for maintenance regimen.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Induction Regimen
    Reporting group description
    		 Induction: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.

    Reporting group values
    		 Induction Regimen Total
    Number of subjects
    		 54 54
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.96 ± 7.48 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 42 42
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 4
        Not Hispanic or Latino
    		 50 50
        Unknown or Not Reported
    		 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 1 1
        White
    		 53 53
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Region of Enrollment
    Units: Subjects
        United States
    		 15 15
        Germany
    		 4 4
        Spain
    		 27 27
        Greece
    		 8 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Necitumumab + Nab-paclitaxel + Carboplatin
    Reporting group description
    		 Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.
    Reporting group title
    Necitumumab + Nab-paclitaxel
    Reporting group description
    		 Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.

    Subject analysis set title
    Necitumumab + Nab-Paclitaxel + Carboplatin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Induction: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.

    Subject analysis set title
    Necitumumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Necitumumab administered IV 800 mg on day 1 and 8 of each cycle (3 week cycles).

    Subject analysis set title
    Carboplatin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles.

    Subject analysis set title
    Paclitaxel
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle.

    Primary: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR]) [1]
    End point description
    ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. Progressive disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Analysis population included all randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.
    End point type
    Primary
    End point timeframe
    From Date of Randomization to Objective Disease Progression (Up to 18 Months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No inferential statistics were planned or conducted for this endpoint.
    End point values
    		 Necitumumab + Nab-paclitaxel + Carboplatin
    Number of subjects analysed
    51
    Units: percentage of participants
        number (not applicable)
    51.0
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

    		 Close Top of page
    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS defined as time from date of randomization until first radiographic documentation of measured PD defined by RECIST v1.1 or death from any cause. PD was at least 20% increase in sum of diameters of target lesions with reference being smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions.If participant does not have complete baseline disease assessment,PFS time censored at date of randomization,regardless of whether or not objectively determined disease progression or death observed for participant.If participant was not known to have died or have objective progression as of data inclusion cutoff date for analysis,the PFS time censored at last adequate tumor assessment date.The use of new anticancer therapy prior to occurrence of PD resulted in censoring at the date of last radiographic assessment prior to initiation of new therapy. Censored participants = 15.
    End point type
    Secondary
    End point timeframe
    From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up to 18 Months)
    End point values
    		 Necitumumab + Nab-paclitaxel + Carboplatin
    Number of subjects analysed
    54 [2]
    Units: Months
        median (confidence interval 95%)
    5.59 (4.24 to 7.69)
    Notes
    [2] - Analysis population included all randomized participants who received at least 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

    		 Close Top of page
    End point title
    		 Overall Survival (OS)
    End point description
    OS defined as the time from the date of randomization to the date of death due to any cause. Participants who are alive at the time of study completion or are lost to follow-up will be censored at the time they were last known to be alive. Analysis population included all randomized participants who received at least 1 dose of study drug. Censored participants = 35.
    End point type
    Secondary
    End point timeframe
    From Date of Randomization until Death Due to Any Cause (Up to 18 Months)
    End point values
    		 Necitumumab + Nab-paclitaxel + Carboplatin
    Number of subjects analysed
    54 [3]
    Units: Months
        median (confidence interval 95%)
    15.54 (10.18 to 99999)
    Notes
    [3] - 99999 = NA; The upper limit of the 95% CI was not calculated due to the high censoring rate.
    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])

    		 Close Top of page
    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
    DCR was percentage of participants with a best overall response of CR,PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as disappearance of all target and nontarget lesions and no appearance of new lesions. PR defined as at least a 30% decrease in sum of LD of target lesions (taking as reference the baseline sum LD),no progression of non-target lesions, and no appearance of new lesions.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions,no progression of non-target lesions,and no appearance of new lesions.PD was at least a 20% increase in sum of the diameters of target lesions, with reference being smallest sum on study and absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions. Analysis population included all randomized participants who received at least 1 dose of study drug and who had a complete radiographic assassessment of baseline.
    End point type
    Secondary
    End point timeframe
    From Date of Randomization to Objective Disease Progression or Start of New Anticancer Therapy (Up to 18 Months)
    End point values
    		 Necitumumab + Nab-paclitaxel + Carboplatin
    Number of subjects analysed
    51
    Units: percentage of participants
        number (not applicable)
    78.4
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin

    		 Close Top of page
    End point title
    		 Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin
    End point description
    The Cmin is the minimum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin. Analysis population included all randomized participants who received at least 1 dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Cycle 3 and cycle 4: predose
    End point values
    		 Necitumumab Carboplatin Paclitaxel
    Number of subjects analysed
    37
    32
    3
    Units: nanogram per milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 3
    65.2 ± 86.9
    0.131 ± 36
    33.6 ± 393
        Cycle 4
    90 ± 74.9
    0.209 ± 197
    107 ± 313
    No statistical analyses for this end point

    Secondary: PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin

    		 Close Top of page
    End point title
    		 PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin
    End point description
    The Cmax is the maximum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin. Analysis population included all randomized participants who received at least 1 dose of study drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Cycle 1, 3 and 4: predose and <15minutes (min) post end-of-infusion
    End point values
    		 Necitumumab Carboplatin Paclitaxel
    Number of subjects analysed
    36
    32
    37
    Units: ng/mL
    geometric mean (geometric coefficient of variation)
        Cycle 1
    231 ± 27.1
    16.4 ± 22
    343 ± 81.2
        Cycle 3
    291 ± 46.5
    16 ± 26.4
    284 ± 73
        Cycle 4
    277 ± 42.5
    10.5 ± 160
    221 ± 77.6
    No statistical analyses for this end point

    Secondary: Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab

    		 Close Top of page
    End point title
    		 Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab
    End point description
    A participant was considered to have an anti-drug antibody response if anti-drug antibodies (ADA) were detected at any time point. Analysis population included all randomized participants who received at least 1 dose of study drug and had evaluable data for antibodies.
    End point type
    Secondary
    End point timeframe
    Predose Cycle 1 Through Short Term Follow Up (Up To 18 Months)
    End point values
    		 Necitumumab + Nab-paclitaxel + Carboplatin
    Number of subjects analysed
    54
    Units: participants
    3
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up to 49 Months
    Adverse event reporting additional description
    All randomized participants who received at least 1 dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Necitumumab+Nab-paclitaxel+Carboplatin: Induction Phase
    Reporting group description
    		 Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 mg/m² on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC 6 mg*min/mL on day 1 of each cycle, for a maximum of 4 cycles. Participants may continue to receive treatment until discontinuation criteria are met.

    Reporting group title
    Necitumumab+Nab-paclitaxel: Maintenance Phase
    Reporting group description
    		 Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met.

    Serious adverse events
    		 Necitumumab+Nab-paclitaxel+Carboplatin: Induction Phase Necitumumab+Nab-paclitaxel: Maintenance Phase
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 54 (33.33%)
    5 / 34 (14.71%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    peripheral ischaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    death
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    fatigue
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multiple organ dysfunction syndrome
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    hypersensitivity
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    interstitial lung disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    delirium
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (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 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (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 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (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
    febrile neutropenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric ulcer
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ileus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    rash maculo-papular
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    urinary retention
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 54 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    pathological fracture
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    diverticulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pulmonary sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (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 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypomagnesaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 34 (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+Nab-paclitaxel+Carboplatin: Induction Phase Necitumumab+Nab-paclitaxel: Maintenance Phase
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 54 (100.00%)
    32 / 34 (94.12%)
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    1 / 34 (2.94%)
         occurrences all number
    4
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    2 / 34 (5.88%)
         occurrences all number
    6
    2
    blood cholesterol increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 34 (5.88%)
         occurrences all number
    1
    3
    blood creatinine increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 34 (5.88%)
         occurrences all number
    8
    3
    lymphocyte count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 54 (11.11%)
    6 / 34 (17.65%)
         occurrences all number
    22
    12
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    32 / 54 (59.26%)
    1 / 34 (2.94%)
         occurrences all number
    85
    3
    platelet count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    18 / 54 (33.33%)
    2 / 34 (5.88%)
         occurrences all number
    41
    2
    weight decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0
    white blood cell count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 54 (22.22%)
    1 / 34 (2.94%)
         occurrences all number
    46
    1
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    dysgeusia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    1 / 34 (2.94%)
         occurrences all number
    5
    1
    paraesthesia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    5 / 34 (14.71%)
         occurrences all number
    1
    12
    peripheral motor neuropathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 34 (8.82%)
         occurrences all number
    6
    9
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 54 (12.96%)
    9 / 34 (26.47%)
         occurrences all number
    9
    19
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    35 / 54 (64.81%)
    15 / 34 (44.12%)
         occurrences all number
    106
    33
    leukopenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    neutropenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 34 (0.00%)
         occurrences all number
    8
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 54 (14.81%)
    2 / 34 (5.88%)
         occurrences all number
    15
    9
    fatigue
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    32 / 54 (59.26%)
    10 / 34 (29.41%)
         occurrences all number
    75
    20
    mucosal inflammation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 34 (2.94%)
         occurrences all number
    8
    1
    oedema peripheral
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 54 (11.11%)
    2 / 34 (5.88%)
         occurrences all number
    6
    2
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    3 / 34 (8.82%)
         occurrences all number
    4
    3
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    19 / 54 (35.19%)
    2 / 34 (5.88%)
         occurrences all number
    25
    2
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    19 / 54 (35.19%)
    5 / 34 (14.71%)
         occurrences all number
    36
    9
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    16 / 54 (29.63%)
    2 / 34 (5.88%)
         occurrences all number
    25
    2
    stomatitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 54 (12.96%)
    2 / 34 (5.88%)
         occurrences all number
    11
    2
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    10 / 54 (18.52%)
    3 / 34 (8.82%)
         occurrences all number
    14
    3
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    7 / 34 (20.59%)
         occurrences all number
    5
    8
    dysphonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    dyspnoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 54 (22.22%)
    4 / 34 (11.76%)
         occurrences all number
    14
    5
    epistaxis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 54 (22.22%)
    1 / 34 (2.94%)
         occurrences all number
    17
    5
    haemoptysis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    2 / 34 (5.88%)
         occurrences all number
    2
    2
    nasal congestion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 54 (11.11%)
    0 / 34 (0.00%)
         occurrences all number
    6
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    productive cough
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    4
    0
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 54 (14.81%)
    1 / 34 (2.94%)
         occurrences all number
    8
    1
    dermatitis acneiform
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    16 / 54 (29.63%)
    4 / 34 (11.76%)
         occurrences all number
    31
    5
    dry skin
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 54 (14.81%)
    5 / 34 (14.71%)
         occurrences all number
    11
    5
    nail discolouration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 54 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    4
    pruritus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 54 (7.41%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0
    rash
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    20 / 54 (37.04%)
    7 / 34 (20.59%)
         occurrences all number
    59
    17
    skin fissures
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    1 / 34 (2.94%)
         occurrences all number
    7
    1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0
    depression
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0
    insomnia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    2 / 34 (5.88%)
         occurrences all number
    5
    2
    back pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    2 / 34 (5.88%)
         occurrences all number
    6
    3
    muscular weakness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    0 / 34 (0.00%)
         occurrences all number
    3
    0
    myalgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    0 / 34 (0.00%)
         occurrences all number
    5
    0
    pain in extremity
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 34 (2.94%)
         occurrences all number
    4
    1
    Infections and infestations
    conjunctivitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    1 / 34 (2.94%)
         occurrences all number
    4
    3
    nail infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 34 (5.88%)
         occurrences all number
    1
    3
    paronychia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 54 (3.70%)
    8 / 34 (23.53%)
         occurrences all number
    2
    12
    respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    9 / 54 (16.67%)
    6 / 34 (17.65%)
         occurrences all number
    12
    8
    urinary tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 54 (5.56%)
    3 / 34 (8.82%)
         occurrences all number
    3
    4
    vaginal infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [1]
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    13 / 54 (24.07%)
    1 / 34 (2.94%)
         occurrences all number
    22
    1
    hypoalbuminaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 54 (12.96%)
    1 / 34 (2.94%)
         occurrences all number
    21
    1
    hypocalcaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    10 / 54 (18.52%)
    1 / 34 (2.94%)
         occurrences all number
    16
    3
    hypoglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 54 (1.85%)
    3 / 34 (8.82%)
         occurrences all number
    1
    3
    hypokalaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    10 / 54 (18.52%)
    1 / 34 (2.94%)
         occurrences all number
    14
    1
    hypomagnesaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    26 / 54 (48.15%)
    9 / 34 (26.47%)
         occurrences all number
    60
    42
    hyponatraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 54 (9.26%)
    1 / 34 (2.94%)
         occurrences all number
    9
    1
    hypophosphataemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 54 (22.22%)
    3 / 34 (8.82%)
         occurrences all number
    30
    38
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jun 2016
    - Changes made to open up the study for European Union (EU) study sites. - Package Leaflet (PL) reference was updated for nab-paclitaxel (abraxane) and carboplatin. - Investigator’s Brochure (IB) information was revised based on the necitumumab IB update

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 26 06:39:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA