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    Clinical Trial Results:
    A Single-arm Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma who are not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy

    Summary
    EudraCT number
    		 2013-000232-10
    Trial protocol
    		 CZ   ES   DE   PL  
    Global end of trial date
    12 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Mar 2021
    First version publication date
    26 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C25007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1154-2250
    Other trial identifiers
    		 NMRR: NMRR-13-1246-18099, REec: REec-2014-0619
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Avenue, Lexington, MA, United States, 02421
    Public contact
    Study Director, Takeda, +1 877-825-3327, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, +1 877-825-3327, TrialDisclosures@takeda.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
    12 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult participants with histologically confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma who have not received a prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or multiagent chemotherapy at the time of study entry.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czechia: 3
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Poland: 26
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Thailand: 10
    Country: Number of subjects enrolled
    Turkey: 9
    Worldwide total number of subjects
    60
    EEA total number of subjects
    33
    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)
    55
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 18 investigative sites in Czech Republic, Germany, Malaysia, Poland, Spain, Thailand and Turkey, from 14 March 2014 to 12 March 2020.

    Pre-assignment
    Screening details
    		 Participants with a diagnosis of relapsed or refractory Hodgkin Lymphoma were enrolled in 1 treatment group to receive brentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion on Day 1 of every 3-week cycle and were followed for progression free survival (PFS) and overall survival (OS) up to the End of study (approximately 6 years).

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

    Arms
    Arm title
    		 Brentuximab Vedotin 1.8 mg/kg
    Arm description
    		 Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab Vedotin
    Investigational medicinal product code
    Other name
    ADCETRIS SGN-35
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Brentuximab vedotin, IV infusion

    Number of subjects in period 1
    		Brentuximab Vedotin 1.8 mg/kg
    Started
    60
    Completed
    25
    Not completed
    35
         Adverse event, serious fatal
    22
         Consent withdrawn by subject
    3
         Symptomatic Deterioration
    1
         Progressive disease
    3
         Lost to follow-up
    1
         Withdrawal of Informed Consent
    2
         Reason not Specified
    2
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Brentuximab Vedotin 1.8 mg/kg
    Reporting group description
    		 Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.

    Reporting group values
    		 Brentuximab Vedotin 1.8 mg/kg Total
    Number of subjects
    		 60 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 55 55
        From 65-84 years
    		 5 5
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.4 ( 13.83 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 24 24
        Male
    		 36 36
    Region of Enrollment
    Units: Subjects
        Czech Republic
    		 3 3
        Germany
    		 2 2
        Malaysia
    		 8 8
        Poland
    		 26 26
        Spain
    		 2 2
        Thailand
    		 10 10
        Turkey
    		 9 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 18 18
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 42 42
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 58 58
        Unknown or Not Reported
    		 0 0
    Baseline Height
    Units: cm
        arithmetic mean (standard deviation)
    		 171.0 ( 9.66 ) -
    Baseline Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 70.3 ( 19.41 ) -
    Body Mass Index (BMI)
    BMI = weight (kg)/[height (m)^2]
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 23.864 ( 5.4085 ) -

    End points

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    End points reporting groups
    Reporting group title
    Brentuximab Vedotin 1.8 mg/kg
    Reporting group description
    		 Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [1]
    End point description
    Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. Intent-to-Treat (ITT) Population included all participants who were enrolled in the study.
    End point type
    Primary
    End point timeframe
    Baseline until disease progression, death or end of study (EOS) (Up to 24 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were not available for this endpoint.
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: percentage of participants
        number (confidence interval 95%)
    50 (37 to 63)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR is defined as the time in months from the date of first documentation of a CR or PR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. ITT Population included all participants who were enrolled in the study. DOR was censored on the date of last disease assessment documenting absence of PD for those that were lost to follow-up, withdrew consent, started a new anticancer therapy other than stem cell transplantation (SCT), or discontinued treatment due to undocumented PD after last disease assessment. All responders were evaluated in this endpoint.
    End point type
    Secondary
    End point timeframe
    From first documented complete or partial remission until disease progression (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    30
    Units: months
        median (confidence interval 95%)
    4.6 (3.42 to 7.85)
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. ITT Population included all participants who were enrolled in the study. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to approximately 6 years
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: months
        median (confidence interval 95%)
    4.8 (2.96 to 5.32)
    No statistical analyses for this end point

    Secondary: Complete Remission Rate

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    End point title
    		 Complete Remission Rate
    End point description
    Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease. ITT Population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression, death or EOS (Up to approximately 6 years)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: percentage of participants
        number (confidence interval 95%)
    13 (6 to 25)
    No statistical analyses for this end point

    Secondary: Duration of Complete Remission

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    End point title
    		 Duration of Complete Remission
    End point description
    Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. ITT Population included all participants who were enrolled in the study. DOR was censored on the date of last disease assessment documenting absence of PD for those that were lost to follow-up, withdrew consent, started a new anticancer therapy other than SCT, or discontinued treatment due to undocumented PD after last disease assessment. Only participants with CR were analyzed for this outcome measure. 9999 = Not estimable. Upper limit of CI was not estimable due to the low number of participants with events.
    End point type
    Secondary
    End point timeframe
    From first documented complete remission until disease progression (up to approximately 6 years)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    8 [2]
    Units: months
        median (confidence interval 95%)
    6.1 (2.10 to 9999)
    Notes
    [2] - Number analyzed is the number of participants with data available at the given time-point.
    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 is the time in months from start of study treatment to date of death due to any cause. ITT Population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure. 9999 indicates median and 95% confidence interval (CI) was not estimable due to the low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant (up to approximately 6 years)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: months
        median (confidence interval 95%)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Received Hematopoietic SCT

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    End point title
    		 Percentage of Participants who Received Hematopoietic SCT
    End point description
    ITT Population included all participants who were enrolled in the study.
    End point type
    Secondary
    End point timeframe
    Baseline up to EOS (up to approximately 6 years)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: percentage of participants
        number (not applicable)
    53
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs

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    End point title
    		 Number of Participants with Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe. Safety Population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.
    End point type
    Secondary
    End point timeframe
    From first dose through 30 days after the last dose of study medication (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: participants
        Any AEs
    52
        Grade 3 or higher AEs
    21
        Drug-related AEs
    41
        Drug-related Grade 3 or higher AEs
    11
        SAEs
    11
        Drug-related SAEs
    3
    No statistical analyses for this end point

    Secondary: Number of Participants with Abnormal Clinical Laboratory Values Reported as AEs

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    End point title
    		 Number of Participants with Abnormal Clinical Laboratory Values Reported as AEs
    End point description
    Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention. Safety Population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.
    End point type
    Secondary
    End point timeframe
    From the first dose through 30 days after the last dose of study medication (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: participants
        Neutrophil count decreased
    2
        Lymphocyte count decreased
    1
        Alanine aminotransferase increased
    2
        Aspartate aminotransferase increased
    2
        Gamma-glutamyltransferase increased
    1
        Blood thyroid stimulating hormone increased
    1
        Platelet count decreased
    1
        Haemoglobin decreased
    1
        Blood alkaline phosphatase increased
    1
        Blood lactate dehydrogenase increased
    1
    No statistical analyses for this end point

    Secondary: Antibody-drug Conjugate (ADC) Serum Concentrations

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    End point title
    		 Antibody-drug Conjugate (ADC) Serum Concentrations
    End point description
    Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate. Pharmacokinetic (PK)-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. 'n' indicates number analysed is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cycle 1 Day 1, Pre-Dose (n=59)
    0.00 ( 0.000 )
        Cycle 1 Day 1, 10 minutes Post-Dose (n=58)
    35504.65 ( 10226.104 )
        Cycle 1 Day 2, 24 hours Post-Dose (n=59)
    14517.67 ( 4481.312 )
        Cycle 1 Day 15, 336 hours Post-Dose (n=55)
    1410.43 ( 1946.525 )
        Cycle 2 Day 1, Pre-Dose (n=52)
    526.42 ( 350.467 )
        Cycle 2 Day 1, 10 minutes Post-Dose (n=53)
    37118.32 ( 11678.088 )
        Cycle 3 Day 1, Pre-Dose (n=49)
    2283.30 ( 7552.322 )
        Cycle 3 Day 1, 10 minutes Post-Dose (n=51)
    35878.77 ( 12724.898 )
        Cycle 3 Day 2, 24 hours Post-Dose (n=54)
    14737.82 ( 4512.358 )
        Cycle 3 Day 15, 336 hours Post-Dose (n=46)
    1586.45 ( 680.955 )
        Cycle 4 Day 1, Pre-Dose (n=51)
    1313.56 ( 2566.360 )
        Cycle 4 Day 1, 10 minutes Post-Dose (n=51)
    42915.34 ( 28221.764 )
        Cycle 5 Day 1, Pre-Dose (n=43)
    1117.01 ( 637.637 )
        Cycle 5 Day 1, 10 minutes Post-Dose (n=41)
    36418.77 ( 10041.935 )
        Cycle 6 Day 1, Pre-Dose (n=37)
    1231.45 ( 714.383 )
        Cycle 6 Day 1, 10 minutes Post-Dose (n=38)
    39000.95 ( 12484.458 )
        Cycle 7 Day 1, Pre-Dose (n=38)
    1285.91 ( 712.625 )
        Cycle 7 Day 1, 10 minutes Post-Dose (n=36)
    38814.82 ( 12471.299 )
        Cycle 8 Day 1, Pre-Dose (n=22)
    1413.98 ( 782.391 )
        Cycle 8 Day 1, 10 minutes Post-Dose (n=24)
    39027.22 ( 9919.251 )
        Cycle 9 Day 1, Pre-Dose (n=15)
    1277.18 ( 594.603 )
        Cycle 9 Day 1, 10 minutes Post-Dose (n=14)
    38359.15 ( 13421.064 )
        Cycle 10 Day 1, Pre-Dose (n=11)
    1498.44 ( 754.721 )
        Cycle 10 Day 1, 10 minutes Post-Dose (n=11)
    39890.12 ( 5376.038 )
        Cycle 11 Day 1, Pre-Dose (n=9)
    1511.35 ( 461.907 )
        Cycle 11 Day 1, 10 minutes Post-Dose (n=9)
    39132.17 ( 6316.541 )
        Cycle 12 Day 1, Pre-Dose (n=10)
    1479.38 ( 397.816 )
        Cycle 12 Day 1, 10 minutes Post-Dose (n=10)
    39955.13 ( 7821.656 )
        Cycle 13 Day 1, Pre-Dose (n=9)
    1423.56 ( 415.744 )
        Cycle 13 Day 1, 10 minutes Post-Dose (n=9)
    37609.69 ( 4563.601 )
        Cycle 14 Day 1, Pre-Dose (n=8)
    1185.62 ( 422.664 )
        Cycle 14 Day 1, 10 minutes Post-Dose (n=8)
    38282.29 ( 10324.023 )
        Cycle 15 Day 1, Pre-Dose (n=8)
    2279.42 ( 2919.545 )
        Cycle 15 Day 1, 10 minutes Post-Dose (n=8)
    39068.14 ( 7981.110 )
        Cycle 16 Day 1, Pre-Dose (n=8)
    1452.23 ( 429.731 )
        Cycle 16 Day 1, 10 minutes Post-Dose (n=8)
    38414.73 ( 9427.315 )
        End of Treatment (n=49)
    1515.30 ( 6413.367 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Total Antibodies (Conjugated and Unconjugated)

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    End point title
    		 Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
    End point description
    Blood samples were collected and tested for conjugated and unconjugated antibodies. PK-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. 'n' indicates Number analysed is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cycle 1 Day 1, Pre-Dose (n=58)
    0.00 ( 0.000 )
        Cycle 1 Day 1, 10 minutes Post-Dose (n=57)
    37329.59 ( 17724.247 )
        Cycle 1 Day 2, 24 hours Post-Dose (n=57)
    23248.90 ( 8228.938 )
        Cycle 1 Day 15, 336 hours Post-Dose (n=59)
    2791.49 ( 1413.452 )
        Cycle 2 Day 1, Pre-Dose (n=56)
    1254.86 ( 774.586 )
        Cycle 2 Day 1, 10 minutes Post-Dose (n=54)
    39801.87 ( 12914.837 )
        Cycle 3 Day 1, Pre-Dose (n=54)
    2645.22 ( 5685.914 )
        Cycle 3 Day 1, 10 minutes Post-Dose (n=52)
    36461.28 ( 11144.634 )
        Cycle 3 Day 2, 24 hours Post-Dose (n=50)
    27071.46 ( 8069.489 )
        Cycle 3 Day 15, 336 hours Post-Dose (n=49)
    4033.28 ( 1760.094 )
        Cycle 4 Day 1, Pre-Dose (n=52)
    2600.73 ( 2275.881 )
        Cycle 4 Day 1, 10 minutes Post-Dose (n=50)
    41823.31 ( 11761.223 )
        Cycle 5 Day 1, Pre-Dose (n=43)
    2690.61 ( 1254.886 )
        Cycle 5 Day 1, 10 minutes Post-Dose (n=42)
    43786.57 ( 15470.979 )
        Cycle 6 Day 1, Pre-Dose (n=39)
    2806.17 ( 1021.877 )
        Cycle 6 Day 1, 10 minutes Post-Dose (n=39)
    44936.89 ( 13827.929 )
        Cycle 7 Day 1, Pre-Dose (n=38)
    3889.94 ( 6201.351 )
        Cycle 7 Day 1, 10 minutes Post-Dose (n=36)
    41840.20 ( 12552.597 )
        Cycle 8 Day 1, Pre-Dose (n=24)
    2932.19 ( 1089.138 )
        Cycle 8 Day 1, 10 minutes Post-Dose (n=24)
    42013.77 ( 12754.334 )
        Cycle 9 Day 1, Pre-Dose (n=15)
    2959.26 ( 970.811 )
        Cycle 9 Day 1, 10 minutes Post-Dose (n=14)
    37300.95 ( 13442.910 )
        Cycle 10 Day 1, Pre-Dose (n=11)
    3189.16 ( 1484.258 )
        Cycle 10 Day 1, 10 minutes Post-Dose (n=11)
    38910.05 ( 6169.552 )
        Cycle 11 Day 1, Pre-Dose (n=10)
    3393.07 ( 1160.604 )
        Cycle 11 Day 1, 10 minutes Post-Dose (n=10)
    41238.25 ( 8081.750 )
        Cycle 12 Day 1, Pre-Dose (n=10)
    3270.44 ( 965.895 )
        Cycle 12 Day 1, 10 minutes Post-Dose (n=10)
    37550.64 ( 12459.906 )
        Cycle 13 Day 1, Pre-Dose (n=9)
    3406.00 ( 1067.414 )
        Cycle 13 Day 1, 10 minutes Post-Dose (n=9)
    35694.80 ( 3720.378 )
        Cycle 14 Day 1, Pre-Dose (n=8)
    2723.01 ( 1286.457 )
        Cycle 14 Day 1, 10 minutes Post-Dose (n=8)
    40848.64 ( 8704.538 )
        Cycle 15 Day 1, Pre-Dose (n=8)
    3111.63 ( 941.200 )
        Cycle 15 Day 1, 10 minutes Post-Dose (n=8)
    37091.56 ( 6644.258 )
        Cycle 16 Day 1, Pre-Dose (n=8)
    3159.38 ( 1017.679 )
        Cycle 16 Day 1, 10 minutes Post-Dose (n=8)
    39266.07 ( 9358.163 )
        End of Treatment (n=50)
    2340.49 ( 6715.837 )
    No statistical analyses for this end point

    Secondary: Monomethyl Auristatin E (MMAE) Serum Concentrations

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    End point title
    		 Monomethyl Auristatin E (MMAE) Serum Concentrations
    End point description
    Blood samples were collected and tested for MMAE serum concentrations. PK-evaluable Population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. 'n' indicates number analysed is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    60
    Units: pg/mL
    arithmetic mean (standard deviation)
        Cycle 1 Day 1, Pre-Dose (n=59)
    0.78 ( 5.976 )
        Cycle 1 Day 1, 10 minutes Post-Dose (n=58)
    591.09 ( 662.608 )
        Cycle 1 Day 2, 24 hours Post-Dose (n=59)
    6056.44 ( 3850.457 )
        Cycle 1 Day 15, 336 hours Post-Dose (n=59)
    746.12 ( 1123.502 )
        Cycle 2 Day 1, Pre-Dose (n=57)
    140.11 ( 111.036 )
        Cycle 2 Day 1, 10 minutes Post-Dose (n=55)
    539.38 ( 593.150 )
        Cycle 3 Day 1, Pre-Dose (n=54)
    130.62 ( 84.152 )
        Cycle 3 Day 1, 10 minutes Post-Dose (n=52)
    484.88 ( 701.402 )
        Cycle 3 Day 2, 24 hours Post-Dose (n=51)
    3076.75 ( 2330.510 )
        Cycle 3 Day 15, 336 hours Post-Dose (n=49)
    442.63 ( 259.360 )
        Cycle 4 Day 1, Pre-Dose (n=52)
    150.95 ( 123.841 )
        Cycle 4 Day 1, 10 minutes Post-Dose (n=52)
    497.20 ( 520.110 )
        Cycle 5 Day 1, Pre-Dose (n=43)
    153.95 ( 123.337 )
        Cycle 5 Day 1, 10 minutes Post-Dose (n=42)
    392.50 ( 320.346 )
        Cycle 6 Day 1, Pre-Dose (n=39)
    158.89 ( 109.024 )
        Cycle 6 Day 1, 10 minutes Post-Dose (n=39)
    369.53 ( 260.871 )
        Cycle 7 Day 1, Pre-Dose (n=38)
    185.91 ( 147.311 )
        Cycle 7 Day 1, 10 minutes Post-Dose (n=37)
    363.83 ( 237.883 )
        Cycle 8 Day 1, Pre-Dose (n=24)
    136.37 ( 86.947 )
        Cycle 8 Day 1, 10 minutes Post-Dose (n=24)
    303.43 ( 202.351 )
        Cycle 9 Day 1, Pre-Dose (n=15)
    142.30 ( 114.794 )
        Cycle 9 Day 1, 10 minutes Post-Dose (n=14)
    224.52 ( 159.833 )
        Cycle 10 Day 1, Pre-Dose (n=11)
    100.78 ( 57.270 )
        Cycle 10 Day 1, 10 minutes Post-Dose (n=11)
    253.73 ( 113.311 )
        Cycle 11 Day 1, Pre-Dose (n=10)
    158.09 ( 169.963 )
        Cycle 11 Day 1, 10 minutes Post-Dose (n=10)
    302.60 ( 175.869 )
        Cycle 12 Day 1, Pre-Dose (n=10)
    175.02 ( 141.192 )
        Cycle 12 Day 1, 10 minutes Post-Dose (n=10)
    382.52 ( 428.255 )
        Cycle 13 Day 1, Pre-Dose (n=9)
    146.76 ( 61.758 )
        Cycle 13 Day 1, 10 minutes Post-Dose (n=9)
    258.78 ( 108.871 )
        Cycle 14 Day 1, Pre-Dose (n=8)
    82.13 ( 22.661 )
        Cycle 14 Day 1, 10 minutes Post-Dose (n=8)
    204.29 ( 121.162 )
        Cycle 15 Day 1, Pre-Dose (n=8)
    133.78 ( 59.213 )
        Cycle 15 Day 1, 10 minutes Post-Dose (n=8)
    246.63 ( 98.399 )
        Cycle 16 Day 1, Pre-Dose (n=8)
    163.39 ( 114.821 )
        Cycle 16 Day 1, 10 minutes Post-Dose (n=8)
    264.63 ( 103.269 )
        End of Treatment (n=50)
    139.72 ( 220.211 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Antitherapeutic Antibodies (ATA)

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    End point title
    		 Number of Participants With Antitherapeutic Antibodies (ATA)
    End point description
    Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers. Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.
    End point type
    Secondary
    End point timeframe
    Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 24 months)
    End point values
    		 Brentuximab Vedotin 1.8 mg/kg
    Number of subjects analysed
    56
    Units: participants
        ATA Positive
    21
        Transient Positive
    17
        Persistently Positive
    4
        ATA Titer Low (≤25)
    21
        ATA Titer High (>25)
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose of study drug up to 30 days post last dose of study drug (Up to 24 months)
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Brentuximab Vedotin 1.8 mg/kg
    Reporting group description
    		 Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.

    Serious adverse events
    		 Brentuximab Vedotin 1.8 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 60 (18.33%)
         number of deaths (all causes)
    22
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Vena cava thrombosis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Serum sickness-like reaction
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Dengue fever
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Brentuximab Vedotin 1.8 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 60 (85.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Lymphoedema
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    5
    Catheter site inflammation
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Chest pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Extravasation
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    11 / 60 (18.33%)
         occurrences all number
    15
    Soft tissue inflammation
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Temperature regulation disorder
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Vaccination site pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    5
    Dyspnoea
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dyspnoea exertional
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    2
    Nasal congestion
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Neutrophil count decreased
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Platelet count decreased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    2
    Weight decreased
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Procedural pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Nervous system disorders
    Autonomic neuropathy
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Facial nerve disorder
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Neuropathy peripheral
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    9
    Paraesthesia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    4
    Peripheral sensory neuropathy
         subjects affected / exposed
    7 / 60 (11.67%)
         occurrences all number
    8
    Polyneuropathy
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    5
    Somnolence
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    6
    Leukocytosis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    8
    Thrombocytopenia
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    9
    Toothache
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    6
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    4
    Dermatitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dermatitis acneiform
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    3
    Pruritus generalised
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Rash macular
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Rash papular
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Rash pruritic
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Renal and urinary disorders
    Renal tubular disorder
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    5
    Back pain
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    3
    Bone pain
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Infections and infestations
    Breast cellulitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    4
    Conjunctivitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Coxsackie viral infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dengue fever
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Device related infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Herpes zoster
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Klebsiella infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    3
    Oral herpes
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    3
    Pseudomonas infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    6
    Viral infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Hyperuricaemia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    4
    Hypomagnesaemia
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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