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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator’s Choice in Subjects with Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

    Summary
    EudraCT number
    		 2011-005738-20
    Trial protocol
    		 BE   GB   FR  
    Global end of trial date
    10 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Feb 2018
    First version publication date
    25 Feb 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    0761-009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01626664
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kyowa Kirin Pharmaceutical Development, Inc
    Sponsor organisation address
    212 Carnegie Center, Princeton, United States, 08540
    Public contact
    Clinical Trial Information, Kyowa Hakko Kirin Pharma, Inc., +1 6099191100, KKD.KW-0761@kyowakirin.com
    Scientific contact
    Clinical Trial Information, Kyowa Hakko Kirin Pharma, Inc., +1 6099191100, KKD.KW-0761@kyowakirin.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
    31 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To estimate overall response rate of KW-0761 for subjects with relapsed or refractory ATL.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization (ICH) consolidated guideline E6 - Good Clinical Practice (GCP) and any applicable national and local laws and regulations. Subjects were provided with written and oral information about the study (aims, methods, anticipated benefits, potential hazards and insurance arrangements). No procedures were conducted until informed consent was provided. The protocol included wording for the treatment of skin rash and hypersensitivity-like reactions (wording regarding premedication prior to KW-0761 infusion was also included in the protocol).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Aug 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Peru: 7
    Country: Number of subjects enrolled
    United States: 39
    Worldwide total number of subjects
    71
    EEA total number of subjects
    22
    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)
    57
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Recruitment opened in August 2012 and closed in May 2015.

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility to participate in the trial. Subjects that met all inclusion/exclusion criteria as per protocol were eligible for entry into the study. A total of 95 subjects were screened, of which 24 failed the screening process. 71 patients were therefore enrolled into the study.

    Period 1
    Period 1 title
    Randomized
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Mogamulizumab (KW-0761)
    Arm description
    		 anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mogamulizumab
    Investigational medicinal product code
    KW-0761
    Other name
    POTELIGEO®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

    Arm title
    		 Investigator's Choice
    Arm description
    		 Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pralatrexate
    Investigational medicinal product code
    Other name
    Folotyn
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

    Investigational medicinal product name
    gemcitabine plus oxaliplatin
    Investigational medicinal product code
    Other name
    Gemzar, Eloxatin, GemOx
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

    Investigational medicinal product name
    DHAP
    Investigational medicinal product code
    Other name
    Decadron, Dexasone, Baycadron, Platinol, Depocyt, Ara-C
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

    Number of subjects in period 1
    		Mogamulizumab (KW-0761) Investigator's Choice
    Started
    47
    24
    Completed
    47
    24
    Period 2
    Period 2 title
    Crossover
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IC Original then Crossover to mogamulizumab
    Arm description
    		 Subjects who were randomized to the Investigator’s Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mogamulizumab
    Investigational medicinal product code
    KW-0761
    Other name
    POTELIGEO®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.0 mg/kg weekly x 4 in cycle 1x then every other week until progression

    Number of subjects in period 2
    		IC Original then Crossover to mogamulizumab
    Started
    18
    Completed
    18

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Mogamulizumab (KW-0761)
    Reporting group description
    		 anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

    Reporting group title
    Investigator's Choice
    Reporting group description
    		 Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

    Reporting group values
    		 Mogamulizumab (KW-0761) Investigator's Choice Total
    Number of subjects
    		 47 24 71
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 35 22 57
        From 65-84 years
    		 12 2 14
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 55 (22 to 82) 49 (24 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 23 14 37
        Male
    		 24 10 34
    Subject analysis sets

    Subject analysis set title
    Mogamulizumab (0761) (intent to treat)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who were randomized to KW-0761

    Subject analysis set title
    Investigator's Choice (intent to treat)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects who were randomized to investigator's choice

    Subject analysis set title
    Crossover (intent to treat)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Randomized to Investigator's choice and cross over to KW-0761

    Subject analysis set title
    Mogamulizumab (0761) (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects randomized to mogamulizumab (0761)

    Subject analysis set title
    Investigator's Choice (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Randomized to investigator's choice

    Subject analysis set title
    Crossover (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Randomized to Investigator's choice and cross over to KW-0761

    Subject analysis sets values
    		 Mogamulizumab (0761) (intent to treat) Investigator's Choice (intent to treat) Crossover (intent to treat) Mogamulizumab (0761) (safety) Investigator's Choice (safety) Crossover (safety)
    Number of subjects
    47
    24
    18
    47
    24
    18
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    35
    22
    17
    35
    22
    17
        From 65-84 years
    12
    2
    1
    12
    2
    1
        85 years and over
    0
    0
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    55.0 (22 to 82)
    49.0 (24 to 80)
    46.8 (24 to 65)
    55.0 (22 to 82)
    49.0 (24 to 80)
    46.8 (24 to 65)
    Gender categorical
    Units: Subjects
        Female
    23
    14
    10
    23
    14
    10
        Male
    14
    10
    8
    14
    10
    8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Mogamulizumab (KW-0761)
    Reporting group description
    		 anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

    Reporting group title
    Investigator's Choice
    Reporting group description
    		 Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP
    Reporting group title
    IC Original then Crossover to mogamulizumab
    Reporting group description
    		 Subjects who were randomized to the Investigator’s Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.

    Subject analysis set title
    Mogamulizumab (0761) (intent to treat)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patients who were randomized to KW-0761

    Subject analysis set title
    Investigator's Choice (intent to treat)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects who were randomized to investigator's choice

    Subject analysis set title
    Crossover (intent to treat)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Randomized to Investigator's choice and cross over to KW-0761

    Subject analysis set title
    Mogamulizumab (0761) (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects randomized to mogamulizumab (0761)

    Subject analysis set title
    Investigator's Choice (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Randomized to investigator's choice

    Subject analysis set title
    Crossover (safety)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Randomized to Investigator's choice and cross over to KW-0761

    Primary: Overall Response Rate

    		 Close Top of page
    End point title
    		 Overall Response Rate [1]
    End point description
    The data entered is based on an independent reviewer assessment. The table comparing independent reviewer to investigator assessment, which also includes crossover patients, is attached.
    End point type
    Primary
    End point timeframe
    Every 8 weeks
    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: Descriptive analysis was utilized for this primary endpoint.
    End point values
    		 Mogamulizumab (0761) (intent to treat) Investigator's Choice (intent to treat)
    Number of subjects analysed
    47
    24
    Units: 71
        Complete Response
    2
    0
        Uncertified Complete Response
    0
    0
        Partial Response
    11
    2
        Stable Disease
    0
    4
        Relapsed Disease or Progressive Disease
    16
    13
        Not Assessable
    18
    5
        Overall Response Rate (Confirmed and Unconfirmed)
    13
    2
        Overall Response Rate Confirmed
    5
    0
    Attachments
    		 Best Overall Response to Treatment
    No statistical analyses for this end point

    Secondary: Progression-free Survival: Randomized Treatment (Intent to Treat Set)

    		 Close Top of page
    End point title
    		 Progression-free Survival: Randomized Treatment (Intent to Treat Set)
    End point description
    End point type
    Secondary
    End point timeframe
    From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months
    End point values
    		 Mogamulizumab (0761) (intent to treat) Investigator's Choice (intent to treat)
    Number of subjects analysed
    47
    24
    Units: 71
    median (confidence interval 95%)
        Progression-free Survival (months)
    0.97 (0.87 to 1.33)
    0.90 (0.77 to 2.73)
        Subjects (%) Alive Without Progression: 1 Month
    47.5 (31.6 to 61.9)
    44.1 (22.8 to 63.4)
        Subjects (%) Alive Without Progression: 2 Months
    29.8 (16.6 to 44.2)
    33.0 (14.2 to 53.3)
        Subjects (%) Alive Without Progression: 3 Months
    24.4 (12.4 to 38.5)
    26.4 (9.4 to 47.3)
        Subjects (%) Alive Without Progression: 4 Months
    18.3 (7.9 to 32.1)
    13.2 (2.4 to 33.5)
        Subjects (%) Alive Without Progression: 5 Months
    18.3 (7.9 to 32.1)
    0 (0 to 0)
        Subjects (%) Alive Without Progression: 6 Months
    12.2 (4.0 to 25.1)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Overall Survival (Intent-to-Treat Set)

    		 Close Top of page
    End point title
    		 Overall Survival (Intent-to-Treat Set)
    End point description
    Overall survival analysis was confounded by the crossover of 75% of Investigator's Choice subjects to mogamulizumab as this analysis was based upon the randomized treatment assignment.
    End point type
    Secondary
    End point timeframe
    up to 36 months
    End point values
    		 Mogamulizumab (0761) (intent to treat) Investigator's Choice (intent to treat)
    Number of subjects analysed
    47
    24
    Units: 71
    median (confidence interval 95%)
        Overall Survival (OS) (months)
    4.90 (2.77 to 15.37)
    6.87 (2.87 to 24.37)
        Subjects (%) Alive for at Least 1 Month
    87.0 (73.2 to 93.9)
    91.7 (70.6 to 97.8)
        Subjects (%) Alive for at Least 2 Months
    75.6 (60.3 to 85.7)
    79.2 (57.0 to 90.8)
        Subjects (%) Alive for at Least 3 Months
    59.1 (43.1 to 72.0)
    70.8 (48.4 to 84.9)
        Subjects (%) Alive for at Least 4 Months
    54.3 (38.5 to 67.7)
    66.7 (44.3 to 81.7)
        Subjects (%) Alive for at Least 5 Months
    49.5 (33.9 to 63.3)
    54.2 (32.7 to 71.4)
        Subjects (%) Alive for at Least 6 Months
    44.3 (29.1 to 58.5)
    54.2 (32.7 to 71.4)
    No statistical analyses for this end point

    Secondary: Quality of Life assessments

    		 Close Top of page
    End point title
    		 Quality of Life assessments
    End point description
    There were no meaningful differences between the mogamulizumab and Investigator’s Choice groups in the FACT-Lym Total or subscale scores, and no indication of a decrement in quality of life associated with mogamulizumab. However, given the small initial sample size and very limited number of subjects with assessments beyond the first few cycles, it is difficult to draw any conclusions.
    End point type
    Secondary
    End point timeframe
    up to 36 months
    End point values
    		 Mogamulizumab (0761) (intent to treat) Investigator's Choice (intent to treat)
    Number of subjects analysed
    47
    24
    Units: 71
    47
    24
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From pre-treatment visit until 90 days after the last dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Mogamulizumab (KW-0761)
    Reporting group description
    		 -

    Reporting group title
    Investigator's Choice
    Reporting group description
    		 -

    Reporting group title
    Crossover
    Reporting group description
    		 Patients in this group crossed over to mogamulizumab after progressing on investigator's choice.

    Serious adverse events
    		 Mogamulizumab (KW-0761) Investigator's Choice Crossover
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 47 (55.32%)
    10 / 24 (41.67%)
    9 / 18 (50.00%)
         number of deaths (all causes)
    30
    10
    12
         number of deaths resulting from adverse events
    10
    1
    2
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary toxicity
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amylase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urine ketone body present
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osmotic demyelination syndrome
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ileitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 47 (4.26%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain of skin
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin hypopigmentation
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 47 (2.13%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Infective thrombosis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 47 (4.26%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    7 / 47 (14.89%)
    4 / 24 (16.67%)
    2 / 18 (11.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Mogamulizumab (KW-0761) Investigator's Choice Crossover
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 47 (95.74%)
    24 / 24 (100.00%)
    18 / 18 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    1
    2
    0
    Flushing
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hypotension
         subjects affected / exposed
    4 / 47 (8.51%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    0
    3
    Chest pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    Fatigue
         subjects affected / exposed
    5 / 47 (10.64%)
    4 / 24 (16.67%)
    1 / 18 (5.56%)
         occurrences all number
    8
    4
    1
    Gait disturbance
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    Malaise
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 24 (12.50%)
    0 / 18 (0.00%)
         occurrences all number
    0
    3
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    0
    2
    0
    Oedema peripheral
         subjects affected / exposed
    8 / 47 (17.02%)
    4 / 24 (16.67%)
    3 / 18 (16.67%)
         occurrences all number
    8
    4
    3
    Pain
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    Pyrexia
         subjects affected / exposed
    4 / 47 (8.51%)
    6 / 24 (25.00%)
    3 / 18 (16.67%)
         occurrences all number
    4
    18
    3
    Reproductive system and breast disorders
    Sexual dysfunction
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Atelectasis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    7 / 47 (14.89%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
         occurrences all number
    7
    2
    1
    Dyspnoea
         subjects affected / exposed
    5 / 47 (10.64%)
    3 / 24 (12.50%)
    2 / 18 (11.11%)
         occurrences all number
    5
    3
    2
    Dyspnoea exertional
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Lung disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Productive cough
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences all number
    3
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 24 (8.33%)
    3 / 18 (16.67%)
         occurrences all number
    0
    2
    3
    Confusional state
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    3
    0
    2
    Hallucination
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    5 / 47 (10.64%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
         occurrences all number
    5
    2
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 47 (6.38%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    4
    12
    0
    Amylase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 47 (10.64%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
         occurrences all number
    5
    13
    2
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 47 (4.26%)
    3 / 24 (12.50%)
    1 / 18 (5.56%)
         occurrences all number
    2
    8
    1
    Blood bicarbonate decreased
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    0
    3
    Blood creatine increased
         subjects affected / exposed
    5 / 47 (10.64%)
    2 / 24 (8.33%)
    1 / 18 (5.56%)
         occurrences all number
    5
    2
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    6 / 47 (12.77%)
    1 / 24 (4.17%)
    1 / 18 (5.56%)
         occurrences all number
    7
    1
    1
    Blood urea increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Lipase increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    3
    Neutrophil count decreased
         subjects affected / exposed
    2 / 47 (4.26%)
    4 / 24 (16.67%)
    1 / 18 (5.56%)
         occurrences all number
    3
    4
    2
    Platelet count decreased
         subjects affected / exposed
    5 / 47 (10.64%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    5
    11
    0
    Platelet count increased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    0
    3
    0
    Urine output decreased
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Head injury
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    21 / 47 (44.68%)
    0 / 24 (0.00%)
    8 / 18 (44.44%)
         occurrences all number
    23
    0
    8
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 47 (10.64%)
    3 / 24 (12.50%)
    1 / 18 (5.56%)
         occurrences all number
    6
    3
    2
    Headache
         subjects affected / exposed
    4 / 47 (8.51%)
    7 / 24 (29.17%)
    0 / 18 (0.00%)
         occurrences all number
    4
    7
    0
    Somnolence
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 47 (21.28%)
    3 / 24 (12.50%)
    6 / 18 (33.33%)
         occurrences all number
    13
    10
    11
    Leukopenia
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences all number
    3
    1
    0
    Leukocytosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    Neutropenia
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 24 (16.67%)
    2 / 18 (11.11%)
         occurrences all number
    10
    8
    3
    Pancytopenia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    6 / 47 (12.77%)
    3 / 24 (12.50%)
    2 / 18 (11.11%)
         occurrences all number
    8
    5
    3
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 47 (2.13%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
         occurrences all number
    1
    2
    3
    Abdominal pain
         subjects affected / exposed
    7 / 47 (14.89%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
         occurrences all number
    7
    2
    2
    Constipation
         subjects affected / exposed
    6 / 47 (12.77%)
    5 / 24 (20.83%)
    1 / 18 (5.56%)
         occurrences all number
    7
    5
    1
    Diarrhoea
         subjects affected / exposed
    3 / 47 (6.38%)
    7 / 24 (29.17%)
    2 / 18 (11.11%)
         occurrences all number
    3
    9
    2
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences all number
    3
    2
    0
    Haematochezia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    6 / 47 (12.77%)
    9 / 24 (37.50%)
    0 / 18 (0.00%)
         occurrences all number
    7
    11
    0
    Obstruction gastric
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 47 (8.51%)
    7 / 24 (29.17%)
    1 / 18 (5.56%)
         occurrences all number
    6
    7
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Blood blister
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Dermatitis acneiform
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Drug eruption
         subjects affected / exposed
    9 / 47 (19.15%)
    0 / 24 (0.00%)
    4 / 18 (22.22%)
         occurrences all number
    15
    0
    6
    Dry skin
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    Ecchymosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    3
    0
    0
    Rash
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    4
    0
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Renal failure acute
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    Renal impairment
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
         occurrences all number
    4
    1
    2
    Back pain
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences all number
    3
    1
    0
    Bone pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    2 / 18 (11.11%)
         occurrences all number
    4
    1
    2
    Myalgia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    3
    Pain in extremity
         subjects affected / exposed
    6 / 47 (12.77%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    6
    0
    1
    Infections and infestations
    Aspergillosis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Candidiasis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Clostridium colitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Haemophilus infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Lung infection
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    3 / 47 (6.38%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences all number
    3
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    3
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 24 (8.33%)
    0 / 18 (0.00%)
         occurrences all number
    2
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 24 (16.67%)
    1 / 18 (5.56%)
         occurrences all number
    4
    4
    1
    Dehydration
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    3 / 18 (16.67%)
         occurrences all number
    0
    0
    3
    Diabetes mellitus
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    5 / 47 (10.64%)
    4 / 24 (16.67%)
    3 / 18 (16.67%)
         occurrences all number
    7
    8
    3
    Hyperglycaemia
         subjects affected / exposed
    3 / 47 (6.38%)
    0 / 24 (0.00%)
    0 / 18 (0.00%)
         occurrences all number
    4
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    4 / 47 (8.51%)
    1 / 24 (4.17%)
    0 / 18 (0.00%)
         occurrences all number
    8
    1
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    3
    Hyperuricaemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 47 (4.26%)
    2 / 24 (8.33%)
    2 / 18 (11.11%)
         occurrences all number
    3
    5
    5
    Hypokalaemia
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 24 (12.50%)
    3 / 18 (16.67%)
         occurrences all number
    4
    5
    4
    Hypomagnesaemia
         subjects affected / exposed
    4 / 47 (8.51%)
    3 / 24 (12.50%)
    4 / 18 (22.22%)
         occurrences all number
    4
    7
    5
    Hyponatraemia
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 24 (0.00%)
    2 / 18 (11.11%)
         occurrences all number
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    3 / 47 (6.38%)
    3 / 24 (12.50%)
    2 / 18 (11.11%)
         occurrences all number
    5
    10
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2012
    • Changed the primary objective from PFS to estimation of ORR in the mogamulizumab treatment group. Progression-free survival and duration of response were made secondary objectives for the mogamulizumab and Investigator’s Choice groups. • Specified that all primary analyses would be based on the Independent Review Committee response assessment for the mogamulizumab group in the ITT population. • Included additional surveillance for autoimmune syndrome development.
    03 Aug 2012
    Addressed comments from regulatory authority review and added additional safety testing as follows: Excluded subjects with smoldering subtype of ATL; Added pregnancy testing prior to each treatment cycle; Specified exclusion of any subjects with contraindication to any of the comparators; Specified when dose adjustments were required for weight change; Added thyroid function tests to monitor autoimmune development.
    04 Mar 2013
    • Modified the Inclusion/Exclusion Criteria to: Allow subjects with Gilbert’s syndrome to be exempt from bilirubin requirement (Inclusion Criterion 9a); Allow subjects who were hepatitis C antibody-positive but hepatitis C quantitative-PCR-negative to be enrolled (Exclusion Criterion 5); Specify that only testing for hepatitis B surface antigen was required (Exclusion Criterion 6) and if the result was positive, the subject was to be excluded; Exclude subjects with QTc interval > 470 msec (Exclusion Criterion 10g). • Specified the permissible dosing interval for mogamulizumab administration during the first treatment cycle. • Allowed subjects with progressive disease in 1 disease compartment to continue to be treated on study, after consultation with the Kyowa Kirin Pharmaceutical Development, Inc. (KKD) Medical Monitor, for a period of up to 8 weeks as actual signs of objective progression may precede subsequent demonstration of an overall response. • Collected serum samples for analysis of anti-mogamulizumab antibodies in subjects who experienced an infusion reaction and clarified the infusion duration (i.e., 1 to 2 hours) in these subjects. • Specified that in cases where PET was not available, a conventional CT with contrast may be performed. • Specified that in this study disease progression and lymphopenia should not be considered AEs.
    12 Mar 2013
    • Modified Exclusion Criterion 6 to exclude subjects with active hepatitis B infection and minimize the risk of reactivation in subjects with a history of hepatitis B. • Modified Table 7.1.1-1 to include testing for hepatitis B virus DNA quantitative by polymerase chain reaction.
    14 Oct 2013
    • Excluded subjects with lymphoma or acute subtypes who had received > 2 prior systemic therapy regimens, and who did not achieve a response (CR or PR) or maintain SD for a minimum of 12 weeks on the most recent prior therapy (Exclusion Criterion 2). • Reduced the washout period from 2 weeks to 1 week for subjects treated with interferon-α and/or zidovudine and instructed the Investigator to contact the Medical Monitor to discuss the washout period for interferon-α, zidovudine, anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications in subjects with rapidly progressive malignant disease. • Allowed subjects with rapidly progressive malignant disease to be crossed over to mogamulizumab with less than a 2-week washout period, if approved by the Medical Monitor, to maximize the opportunity for subjects to receive timely subsequent treatment in the setting of this aggressive disease. • Allowed subjects to receive influenza vaccination that consisted of killed virus. • Reduced the number of follow-up scans in subjects with the chronic subtype of ATL in cases where the subjects did not have evidence of ATL on the PET/CT at baseline. These subjects were required to undergo follow-up PET/CT scans to confirm a CR and/or if progressive disease was suspected in a compartment that could best be assessed by PET/CT. Due to the more indolent nature of the chronic subtype, regularly scheduled radiographs in the absence of symptoms of progression were unnecessary.
    21 Apr 2014
    • Provided updated safety information for mogamulizumab based on Edition 10 of the Investigator’s Brochure. • Removed the immunogenicity assessment during the follow-up period since the sample was collected at the End-of-Treatment visit. • Allowed a subject who had been on a stable dose of medium or low potency topical corticosteroids for at least 4 weeks prior to the Pre-treatment Visit to be enrolled. The subject could continue therapy at the same dosage during the study; however, the Investigator was to attempt to taper the use to the lowest dosage tolerable (Exclusion Criterion 19). • Recommended premedication with acetaminophen or paracetamol orally and diphenhydramine 50 mg iv (or equivalent anti-histamine) for all subjects before the first mogamulizumab infusion. For subjects who experienced an infusion-related reaction, premedication was recommended prior to every subsequent infusion. • Specified that any subject who experienced a Grade 4 infusion reaction was to be discontinued from the study. • Required recording of medication taken during follow-up if used to treat an AE or was temporally associated with an AE and may have a causal relationship. • Specified that paraffin blocks or fresh tissue samples were preferred for determination of CCR4 expression. As KKD is developing a companion diagnostic assay, the remainder of the skin biopsy specimens was to be archived. Since unstained slides may have a shorter stability period, it was not recommended that they be submitted for this purpose. • In order to assess the PK exposure-response relationship for mogamulizumab, subjects who crossed over to mogamulizumab were also to undergo the collection of serum samples. • Updated the definition of relapsed or progressive disease in subjects with disease in the peripheral blood. The minimum threshold of disease was established as > 5% of abnormal cells; because of possible variability in the determination in subjects with blood disease changes only, a subseque
    02 Sep 2015
    • Clarified that subjects would be contacted by telephone every 30 days (± 7 days) up to 90 days (± 7 days) after the last dose of study medication or initiation of alternative therapy, whichever came first, to confirm and document any new onset AEs or toxicities. This instruction did not preclude an Investigator from reporting any AE occurring at any time after completion of the study if a causal relationship to study drug was suspected. • Revised the Exposure-response Analysis section to reflect the current plan for presenting the exposure-response data analysis. This study provides descriptive statistics on the PK data. Data from previously performed studies would be used to develop the model and data from this study (0761-009) would be incorporated into the analysis. Conclusions on exposure-response results are developed in a supplemental PK report based on the 31 Mar 2016 clinical cut-off.
    28 Apr 2016
    • Added a new protocol section, i.e., Study Procedures for Ongoing Subjects at the Time of Cutoff for Primary Analysis to define study criteria for continued treatment, clarify subject assessments to be performed by the Investigator, and specify relevant data collection required for subjects continuing to receive mogamulizumab at the clinical data cut-off date to be in accordance with Standard of Care at the Investigative site. • Specified blood/serum sample collection times for immunogenicity and natural ligand measurements (i.e., to be collected every 8 weeks during treatment) for subjects continuing to receive mogamulizumab at the clinical data cut-off date.

    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 20:12:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA