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    Clinical Trial Results:
    A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects with Metastatic Melanoma

    Summary
    EudraCT number
    		 2011-001282-40
    Trial protocol
    		 DE   GB  
    Global end of trial date
    10 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Apr 2021
    First version publication date
    25 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MORAb-004-201-Mel
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01335009
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai Inc.
    Sponsor organisation address
    155 Tice Boulevard, Woodcliff Lake, United States, 07677
    Public contact
    Eisai Medical Information, Eisai Inc., 1 8882742378, esi_medinfo@eisai.com
    Scientific contact
    Eisai Medical Information, Eisai Inc., 1 8882742378, esi_medinfo@eisai.com
    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
    10 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the rate of progression free survival (PFS) of 2 dose levels of MORAb-004 at 24 weeks in subjects with metastatic melanoma, based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Conference on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Conference on Harmonisation of Pharmaceuticals for Human Use - Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. - Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2011
    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
    United States: 68
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    76
    EEA total number of subjects
    3
    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)
    41
    From 65 to 84 years
    33
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at 29 sites in 4 countries (the United States, Australia, Germany, and the United Kingdom), 20 of which enrolled subjects.

    Pre-assignment
    Screening details
    		 A total of 76 subjects were randomized to treatment with MORAb-004 (40 subjects in the 2 milligram per kilogram [mg/kg] group and 36 subjects in the 4 mg/kg group).

    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
    		 MORAb-004 2 mg/kg
    Arm description
    		 Subjects received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using computed tomography/magnetic resonance imaging (CT/MRI) or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MORAb-004 2 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the each 28-day cycle (4 administrations per cycle) until disease progression, using CT/MRI or until they discontinued the study for any reason.

    Arm title
    		 MORAb-004 4 mg/kg
    Arm description
    		 Subjects received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MORAb-004 4 mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the each 28-day cycle (4 administrations per cycle) until disease progression, using CT/MRI or until they discontinued the study for any reason.

    Number of subjects in period 1
    		MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Started
    40
    36
    Completed
    9
    3
    Not completed
    31
    33
         Consent withdrawn by subject
    1
    1
         Death
    28
    32
         Too ill to travel to study sites
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MORAb-004 2 mg/kg
    Reporting group description
    		 Subjects received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using computed tomography/magnetic resonance imaging (CT/MRI) or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.

    Reporting group title
    MORAb-004 4 mg/kg
    Reporting group description
    		 Subjects received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.

    Reporting group values
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg Total
    Number of subjects
    		 40 36 76
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.1 ± 12.22 61.2 ± 12.15 -
    Gender categorical
    Units: Subjects
        Female
    		 18 9 27
        Male
    		 22 27 49
    Race
    Units: Subjects
        White
    		 39 34 73
        Black or African American
    		 0 1 1
        Other
    		 1 1 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 4 5
        Non-Hispanic or Non-Latino
    		 39 32 71

    End points

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    End points reporting groups
    Reporting group title
    MORAb-004 2 mg/kg
    Reporting group description
    		 Subjects received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using computed tomography/magnetic resonance imaging (CT/MRI) or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.

    Reporting group title
    MORAb-004 4 mg/kg
    Reporting group description
    		 Subjects received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.

    Primary: Percentage of Participants With Progression-free Survival (PFS) at Week 24

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    End point title
    		 Percentage of Participants With Progression-free Survival (PFS) at Week 24 [1]
    End point description
    PFS was defined as the time (in weeks) from the date of randomization to the date of the first sign of disease progression (PD) based on Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, or date of death, regardless of cause. PD greater than or equal to (>=) 20 percent (%) increase in the nadir of total tumor burden (TTB) (minimum 5 millimeter [mm]). Subjects who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Subjects who received a new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was started. PFS was analyzed using Kaplan Meier method. Primary efficacy population included all subjects in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized.
    End point type
    Primary
    End point timeframe
    Week 24
    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: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Number of subjects analysed
    39 [2]
    36 [3]
    Units: percentage of subjects
        number (confidence interval 95%)
    13.5 (5.0 to 26.4)
    8.9 (2.3 to 21.3)
    Notes
    [2] - Primary Efficacy Population
    [3] - Primary Efficacy Population
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) at Weeks 16 and 52

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    End point title
    		 Progression-free Survival (PFS) at Weeks 16 and 52
    End point description
    PFS was defined as the time (in weeks) from the date of randomization to the date of the first observation of PD (RECIST version 1.1) or date of death, regardless of the cause. PD >=20% increase in the nadir of TTB (minimum 5 mm). Subjects who were alive with no disease progression had their PFS time censored at the date of their last tumor assessment. Subjects who received new anti-cancer therapy before disease progression had their PFS time censored at the date of their last tumor assessment before the new anti-cancer therapy was initiated. PFS was based on the Kaplan-Meier method. Primary efficacy population included all subjects in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Week 16 and Week 52
    End point values
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Number of subjects analysed
    39 [4]
    36 [5]
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 16
    32.5 (18.3 to 47.6)
    20.8 (9.2 to 35.7)
        Week 52
    0 (0 to 0)
    8.9 (2.3 to 21.3)
    Notes
    [4] - Primary Efficacy Population
    [5] - Primary Efficacy Population
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined as the time (in weeks) from the date of randomization to the date of death, regardless of cause. In the absence of death confirmation, or for subjects alive at the time of analysis, the survival time was censored at the date of the last study follow-up. OS was calculated using the Kaplan-Meier method. Primary efficacy population included all subjects in the safety population who meet all key eligibility criteria (including measurable disease at baseline after at least 1 systemic treatment) analyzed by the dose level to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Date of first study treatment (Day 1) to date of death or up to approximately 2 years 7 months
    End point values
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Number of subjects analysed
    39 [6]
    36 [7]
    Units: weeks
        median (confidence interval 95%)
    40.9 (29.0 to 53.3)
    29.3 (22.9 to 35.4)
    Notes
    [6] - Primary Efficacy Population
    [7] - Primary Efficacy Population
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Overall Response

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    End point title
    		 Percentage of Participants With Overall Response
    End point description
    ORR was defined as the percentage of subjects with best overall response (BOR) of complete response (CR) or partial response (PR) that occurred (defined by RECIST version 1.1) using CT/MRI. Per RECIST 1.1, CR= disappearance of all lesions; PR greater than or equal to (>=) 30percent (%) decrease from baseline in TTB. ORR population included a subset of subjects from the primary efficacy population who had at least 1 on-study radiologic evaluation performed (in addition to their baseline evaluation), analyzed by the dose level received.
    End point type
    Secondary
    End point timeframe
    Date of first study treatment (Day 1) to complete response or partial response, assessed up to approximately 2 years 7 months
    End point values
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Number of subjects analysed
    34 [8]
    32 [9]
    Units: percentage of subjects
        number (confidence interval 95%)
    0 (0 to 0)
    3.1 (0.0 to 9.2)
    Notes
    [8] - ORR Population
    [9] - ORR Population
    No statistical analyses for this end point

    Secondary: Optimal Biologic Dosing (OBD) of Morab-004

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    End point title
    		 Optimal Biologic Dosing (OBD) of Morab-004
    End point description
    OBD is defined as the dose level/exposure level at which three parameters are met: 1) adequate pharmacokinetic (PK) profile with a serum half-life (t1/2) of >=48 hours, 2) at least minimal demonstration of antitumor efficacy (50% or greater PFS rate at 16 weeks), and 3) change of 25% or greater from baseline value in any of the pharmacodynamic (PD) parameters assessed in the study in 30% of subjects at that dose level. All subjects in the safety population who receive at least one dose of MORAb-004 and who have at least one on-treatment PK/PD assessment performed that is sufficient to evaluate the endpoint of interest. Here '99999' signifies that OBD was not evaluated due to minimal antitumor efficacy (less than 50%) hence, was not demonstrated.
    End point type
    Secondary
    End point timeframe
    Day 1 Cycle 1 (Cycle length = 28 days)
    End point values
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Number of subjects analysed
    40
    36
    Units: milligram(s)
        number (not applicable)
    99999
    99999
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug to 45 days after the last dose of study drug (up to approximately 8 years 11 months)
    Adverse event reporting additional description
    Safety population included all randomized subjects who received at least 1 dose of study drug, analyzed by the actual treatment received. The severity of AE toxicities was graded according to the NCI CTCAE criteria, v4.03, where applicable.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    MORAb-004 2 mg/kg
    Reporting group description
    		 Subjects received one cycle of treatment with MORAb-004 2 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using computed tomography/magnetic resonance imaging (CT/MRI) or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.

    Reporting group title
    MORAb-004 4 mg/kg
    Reporting group description
    		 Subjects received one cycle of treatment with MORAb-004 4 mg/kg, administered intravenously on Days 1, 8, 15, and 22 of the 28-day cycle (4 administrations per cycle). Subjects who completed Cycle 1 continued with additional cycles without interruption or dose escalation until disease progression, using CT/MRI or until they discontinued the study for any reason. Subjects were assessed for disease progression by CT/MRI every 8 weeks from the date of first study treatment (that is, Cycle 1 Day 1), regardless of delays in treatment.

    Serious adverse events
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 40 (42.50%)
    16 / 36 (44.44%)
         number of deaths (all causes)
    5
    4
         number of deaths resulting from adverse events
    4
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Metastatic malignant melanoma
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (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
    Infusion related reaction
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         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
    Pulmonary embolism
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (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
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tibia fracture
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (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
    Cellulitis
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MORAb-004 2 mg/kg MORAb-004 4 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 40 (100.00%)
    36 / 36 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    6 / 40 (15.00%)
    1 / 36 (2.78%)
         occurrences all number
    10
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Flushing
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Hypotension
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Lymphoedema
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Vena cava thrombosis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Swelling
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Chills
         subjects affected / exposed
    13 / 40 (32.50%)
    18 / 36 (50.00%)
         occurrences all number
    13
    20
    Fatigue
         subjects affected / exposed
    18 / 40 (45.00%)
    18 / 36 (50.00%)
         occurrences all number
    28
    28
    Feeling cold
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Feeling hot
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Hernia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Infusion related reaction
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 36 (2.78%)
         occurrences all number
    4
    3
    Infusion site extravasation
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Localised oedema
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Oedema peripheral
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 36 (8.33%)
         occurrences all number
    4
    6
    Pain
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    9 / 40 (22.50%)
    12 / 36 (33.33%)
         occurrences all number
    11
    17
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Scrotal oedema
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 40 (12.50%)
    8 / 36 (22.22%)
         occurrences all number
    9
    9
    Dyspnoea
         subjects affected / exposed
    4 / 40 (10.00%)
    6 / 36 (16.67%)
         occurrences all number
    6
    7
    Dyspnoea exertional
         subjects affected / exposed
    4 / 40 (10.00%)
    2 / 36 (5.56%)
         occurrences all number
    4
    2
    Epistaxis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Pleural effusion
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Pleuritic pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Postnasal drip
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Productive cough
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Pulmonary congestion
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Rhonchi
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    2 / 40 (5.00%)
    4 / 36 (11.11%)
         occurrences all number
    2
    4
    Confusional state
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 36 (11.11%)
         occurrences all number
    0
    6
    Depression
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Disorientation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Mood altered
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Blood urea increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Blood urine present
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Breath sounds abnormal
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram RR interval prolonged
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Eosinophil count increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    International normalised ratio increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Protein urine present
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    QRS axis abnormal
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Respiratory rate increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Specific gravity urine increased
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    White blood cell count increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Excoriation
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Incision site pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Joint dislocation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Joint sprain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Skin laceration
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Tongue injury
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Atrial flutter
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Balance disorder
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Brain oedema
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Coma
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 36 (11.11%)
         occurrences all number
    4
    4
    Dysgeusia
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    2
    Dyskinesia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    21 / 40 (52.50%)
    21 / 36 (58.33%)
         occurrences all number
    35
    31
    Hypoaesthesia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    4
    0
    Sciatica
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Sinus headache
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
         occurrences all number
    1
    4
    Tremor
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 40 (20.00%)
    10 / 36 (27.78%)
         occurrences all number
    16
    22
    Leukocytosis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Lymph node pain
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    5
    0
    Lymphopenia
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    5
    Thrombocytopenia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Eye disorders
    Conjunctival oedema
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Diabetic retinopathy
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Eye discharge
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Macular oedema
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Abdominal pain
         subjects affected / exposed
    5 / 40 (12.50%)
    5 / 36 (13.89%)
         occurrences all number
    5
    6
    Abdominal pain lower
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    3
    Abdominal tenderness
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Colitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    9 / 40 (22.50%)
    9 / 36 (25.00%)
         occurrences all number
    11
    9
    Dental caries
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    4 / 40 (10.00%)
    6 / 36 (16.67%)
         occurrences all number
    4
    10
    Dry mouth
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Dyspepsia
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 36 (8.33%)
         occurrences all number
    4
    4
    Dysphagia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Flatulence
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Gingival bleeding
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Intussusception
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    13 / 40 (32.50%)
    15 / 36 (41.67%)
         occurrences all number
    18
    21
    Stomatitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    3 / 40 (7.50%)
    9 / 36 (25.00%)
         occurrences all number
    3
    12
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Blister
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    4
    0
    Erythema
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 36 (8.33%)
         occurrences all number
    3
    4
    Fungating wound
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Intertrigo
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Night sweats
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Pruritus
         subjects affected / exposed
    3 / 40 (7.50%)
    2 / 36 (5.56%)
         occurrences all number
    4
    3
    Rash
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Rash generalised
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Rash macular
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Skin discolouration
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Skin disorder
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Skin haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous nodule
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Swelling face
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Vitiligo
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Haematuria
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hypertonic bladder
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Urinary retention
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 40 (22.50%)
    5 / 36 (13.89%)
         occurrences all number
    10
    6
    Arthritis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    5 / 40 (12.50%)
    9 / 36 (25.00%)
         occurrences all number
    5
    9
    Flank pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Joint stiffness
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 36 (13.89%)
         occurrences all number
    1
    5
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
         occurrences all number
    3
    3
    Neck pain
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Osteoarthritis
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Pain in extremity
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 36 (8.33%)
         occurrences all number
    5
    3
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Cystitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Lung infection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Oral herpes
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Skin infection
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
    5 / 36 (13.89%)
         occurrences all number
    2
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 40 (22.50%)
    11 / 36 (30.56%)
         occurrences all number
    14
    12
    Dehydration
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Hyponatraemia
         subjects affected / exposed
    1 / 40 (2.50%)
    4 / 36 (11.11%)
         occurrences all number
    1
    5
    Hypophosphataemia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2011
    Inclusion and Exclusion criterions were revised.
    03 Nov 2011
    Made the tumor tissue biopsy for PD biomarker analysis optional for all subjects randomized after the first 30 subjects; added additional patient selection biomarker studies in NRAS and BRAF mutation status; increased the number of sites participating globally from 20 to approximately 28; requested optional preserved diagnostic tissue sample (from primary melanoma lesion) from all subjects; clarified that study population included subjects with cutaneous (nonocular, nonmucosal) melanoma; and added pregnancy as reason for discontinuation from treatment with MORAb‐004.
    22 Jan 2014
    Established a data cut-off for the OS analysis (02 Dec 2013). As of the data cut-off date for this clinical study report, 2 subjects were still receiving study drug. These subjects will continue to be administered infusions of MORAb-004 weekly per protocol, and will have a subset of protocol assessments conducted until documented disease progression per RECIST. All subjects in follow-up for OS as of 02 Dec 2013 will continue to be followed for survival and additional anticancer therapies.

    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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