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    Clinical Trial Results:
    Targeted BEACOPP variants in patients with newly diagnosed advanced classical Hodgkin Lymphoma

    Summary
    EudraCT number
    		 2011-005082-21
    Trial protocol
    		 DE  
    Global end of trial date
    15 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Apr 2020
    First version publication date
    08 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-1491
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01569204
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Cologne
    Sponsor organisation address
    Albertus Magnus-Platz, Köln, Germany, 50923
    Public contact
    Trial Coordination Center of the German Hodgkin Study Group (GHSG), German Hodgkin Study Group (GHSG), 0049 22147888200, ghsg@uk-koeln.de
    Scientific contact
    Trial Coordination Center of the German Hodgkin Study Group (GHSG), German Hodgkin Study Group (GHSG), 0049 22147888200, ghsg@uk-koeln.de
    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
    03 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the trial was to implement the antibody-drug conjugate brentuximab vedotin into the first-line treatment of patients with advanced classical Hodgkin lymphoma. The combination of targeted drugs such as brentuximab vedotin with conventional chemotherapy might allow reducing the doses of classical chemotherapeutic substances without compromising treatment efficacy. One major goal of this trial is to generate a novel BEACOPP-based treatment protocol to serve as comparator in the next GHSG treatment optimization trial for patients with newly diagnosed advanced classical Hodgkin lymphoma (HD21).
    Protection of trial subjects
    Written informed consent before study entry, frequent DMC monitoring, hospitalization during first cycle recommended, mandatory prophylaxis during chemotherapy, dose reduction strategy in case of adverse events
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    104
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 26 October 2012 and 15 May 2014, a total of 104 patients with newly diagnosed advanced-stage Hodgkin lymphoma were recruited in 20 trial sites in Germany.

    Pre-assignment
    Screening details
    		 Main inclusion criteria: previously untreated classical Hodgkin lymphoma in advanced stages, normal organ function, life expectancy >3 months. Main exclusion criteria: severe pulmonary or cardiac disease, HIV positivity, WBC count <3x10⁹/L, platelet count <100x10⁹/L, bilirubin >2 mg/dL, AST or ALT >100 U/L, pregnancy or lactation, ECOG >2.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BrECAPP
    Arm description
    		 Six 21-day cycles of BrECAPP
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.8 mg/kg body weight on day 1 of each 21-day cycle, calculated with the patient's actual weight up to 100 kg. Patients with a weight of more than 100 kg receive the maximum dose of 180 mg of brentuximab vedotin.

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    200 mg/m² body surface area on days 2-4 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this. Etoposide phosphate may be applied as etoposide-equivalent dose: 113 mg etoposide phosphate is equivalent to 100 mg etoposide. This difference is due to different molecular weights.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1250 mg/m² body surface area on day 2 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this. Uromitexan according to current standards is obligatory. The patient should ingest 2.5 liters of fluid on the day of administration.

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    35 mg/m² body surface area on day 2 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this.

    Investigational medicinal product name
    Procarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg/m² body surface area on days 2-8 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg/m² body surface area on days 2-15 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this.

    Arm title
    		 BrECADD
    Arm description
    		 Six 21-day cycles of BrECADD
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.8 mg/kg body weight on day 1 of each 21-day cycle, calculated with the patient's actual weight up to 100 kg. Patients with a weight of more than 100 kg receive the maximum dose of 180 mg of brentuximab vedotin.

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mg/m² body surface area on days 2-4 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this. Etoposide phosphate may be applied as etoposide-equivalent dose: 113 mg etoposide phosphate is equivalent to 100 mg etoposide. This difference is due to different molecular weights.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1250 mg/m² body surface area on day 2 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this. Uromitexan according to current standards is obligatory. The patient should ingest 2.5 liters of fluid on the day of administration.

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m² body surface area on day 2 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this.

    Investigational medicinal product name
    Dacarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion, Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    250 mg/m² body surface area on days 3-4 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this.

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m² body surface area on days 2-5 of each 21-day cycle. The maximum upper limit for the calculation of chemotherapy is fixed at a body surface of 2.1 m², even if the calculated body surface exceeds this.

    Number of subjects in period 1
    		BrECAPP BrECADD
    Started
    52
    52
    Started randomized treatment
    50
    52
    Completed
    48
    52
    Not completed
    4
    0
         Consent withdrawn by subject
    1
    -
         Physician decision
    1
    -
         Adverse event, non-fatal
    1
    -
         Violation of I/E criteria
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BrECAPP
    Reporting group description
    		 Six 21-day cycles of BrECAPP

    Reporting group title
    BrECADD
    Reporting group description
    		 Six 21-day cycles of BrECADD

    Reporting group values
    		 BrECAPP BrECADD Total
    Number of subjects
    		 52 52 104
    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)
    		 52 52 104
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 29.5 (18 to 60) 28.5 (18 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 21 20 41
        Male
    		 31 32 63
    Ann Arbor stage
    Units: Subjects
        IIB
    		 10 8 18
        IIIA
    		 15 9 24
        IIIB
    		 8 12 20
        IVA
    		 5 5 10
        IVB
    		 14 18 32
    Large mediastinal mass
    Units: Subjects
        No
    		 31 31 62
        Yes
    		 21 21 42
    Extranodal disease
    Units: Subjects
        No
    		 41 37 78
        Yes
    		 11 15 26
    At least 3 nodal areas involved
    Units: Subjects
        No
    		 8 10 18
        Yes
    		 44 42 86
    Elevated ESR
    Units: Subjects
        No
    		 21 13 34
        Yes
    		 31 39 70
    International prognostic score
    Units: Subjects
        0-2
    		 35 33 68
        3-7
    		 17 19 36
    WHO activity index
    Units: Subjects
        0 (fully active)
    		 23 18 41
        1 (able to do light work)
    		 27 34 61
        2 (unable to do light work)
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    BrECAPP
    Reporting group description
    		 Six 21-day cycles of BrECAPP

    Reporting group title
    BrECADD
    Reporting group description
    		 Six 21-day cycles of BrECADD

    Primary: Complete response to chemotherapy

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    End point title
    		 Complete response to chemotherapy [1]
    End point description
    We defined complete response as the achievement of either complete remission, partial remission with residual lymphoma less than 2.5 cm, or PET negativity (Deauville score 1-3) after chemotherapy, according to central review. Both arms were analyzed separately. Assuming a complete response in 90% in each arm, we would be able to test the null hypothesis "complete response rate is 70% or lower" with a one-sided significance level of 2.5% and a power of 90% per arm. We calculated one-sided 97.5% Clopper-Pearson exact binominal CIs for observed responses in order to exclude the benchmark of 70%.
    End point type
    Primary
    End point timeframe
    The CT-based restaging was scheduled within the last week of the last chemotherapy cycle. In patients with residual lymphoma of 2.5 cm or larger, a PET scan was to be performed at least 3 weeks after the end of the last chemotherapy cycle.
    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: This is a phase-2 study with 2 regimens to be evaluated independently. There is no arm comparison but 2 single-arm analyses, which cannot be entered in the system. Analyses were as follows: The null hypothesis H0 “Complete response rate<=70%” was tested versus a one-sided alternative via a one-sided 97.5% CI per arm. The lower confidence limits were 73% and 77%, respectively, and thus both above the efficacy benchmark. In conclusion, both null hypotheses could be rejected.
    End point values
    		 BrECAPP BrECADD
    Number of subjects analysed
    49 [2]
    52
    Units: subjects
        Yes
    42
    46
        No
    7
    6
    Notes
    [2] - 3/52 patients excluded: 2 did not receive any study treatment, 1 violated I/E criteria
    No statistical analyses for this end point

    Primary: Complete remission

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    End point title
    		 Complete remission [3]
    End point description
    We defined complete remission as complete remission after completion of study treatment or, in case of residual lymphoma after completion of study treatment, freedom from progression without additional treatment for at least 6 months. Both arms were analyzed separately. The co-primary efficacy endpoint was only to be tested if the null hypothesis for complete response could not be rejected. Assuming a complete remission rate of 95% for each arm, we would be able to test the null hypothesis "complete remission rate is 80% or lower" with a one-sided significance level of 2.5% and a power of 90% per arm. To this end, one-sided 97.5% Clopper-Pearson exact binominal CIs for observed remissions would be calculated in order to exclude the benchmark of 80%.
    End point type
    Primary
    End point timeframe
    Within 6 months after end of study treatment
    Notes
    [3] - 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: The co-primary efficacy endpoint "complete remission" was only to be tested if the null hypothesis for the primary endpoint "complete response" could not be rejected. As the null hypothesis for "complete response" could be rejected for both regimens, a confirmative test of "complete remission" was not done.
    End point values
    		 BrECAPP BrECADD
    Number of subjects analysed
    49 [4]
    52
    Units: patients
        Yes
    46
    46
        No
    3
    6
    Notes
    [4] - 3/52 patients excluded: 2 did not receive any study treatment, 1 violated I/E criteria
    No statistical analyses for this end point

    Secondary: Progression-free survival

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    End point title
    		 Progression-free survival
    End point description
    Progression-free survival is defined as time from randomization to disease progression or death from any cause and censored at the date of last tumor assessment for patients alive without progressive disease.
    End point type
    Secondary
    End point timeframe
    18-months progression-free survival will be reported.
    End point values
    		 BrECAPP BrECADD
    Number of subjects analysed
    49 [5]
    52
    Units: percent
        number (confidence interval 95%)
    95 (85 to 100)
    89 (77 to 100)
    Notes
    [5] - 3/52 patients excluded: 2 did not receive any study treatment, 1 violated I/E criteria
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All events up to 30 days after end of treatment had to be reported. Events that occured later than 30 days after the end of treatment had to be reported if causality was rated at least as “possible”.
    Adverse event reporting additional description
    AEs were assessed on the therapy administration CRFs. SAEs were additionally assessed on specific forms. SAEs may thus be reported twice; non-serious and SAEs might include duplicate events and do not add up to a total number of AEs. Hospitalization in connection with therapeutic measures of the trial and deaths from HL were no SAEs in this trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    BrECAPP
    Reporting group description
    		 Six 21-day cycles of BrECAPP

    Reporting group title
    BrECADD
    Reporting group description
    		 Six 21-day cycles of BrECADD

    Serious adverse events
    		 BrECAPP BrECADD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 50 (42.00%)
    18 / 52 (34.62%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Investigations
         subjects affected / exposed
    5 / 50 (10.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    4 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 52 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    7 / 50 (14.00%)
    9 / 52 (17.31%)
         occurrences causally related to treatment / all
    9 / 9
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 52 (5.77%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    6 / 50 (12.00%)
    7 / 52 (13.46%)
         occurrences causally related to treatment / all
    6 / 6
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BrECAPP BrECADD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 50 (100.00%)
    51 / 52 (98.08%)
    Nervous system disorders
    Nervous system disorders, sensory
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    16 / 50 (32.00%)
    18 / 52 (34.62%)
         occurrences all number
    37
    41
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    47 / 50 (94.00%)
    50 / 52 (96.15%)
         occurrences all number
    234
    251
    Thrombocytopenia
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    45 / 50 (90.00%)
    43 / 52 (82.69%)
         occurrences all number
    190
    180
    Leukopenia
         subjects affected / exposed
    48 / 50 (96.00%)
    46 / 52 (88.46%)
         occurrences all number
    232
    222
    General disorders and administration site conditions
    Drug fever
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 50 (10.00%)
    2 / 52 (3.85%)
         occurrences all number
    7
    3
    Gastrointestinal disorders
    Nausea or vomiting
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    22 / 50 (44.00%)
    19 / 52 (36.54%)
         occurrences all number
    46
    32
    Mucositis
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 50 (24.00%)
    9 / 52 (17.31%)
         occurrences all number
    14
    11
    Gastrointestinal tract disorder
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 50 (28.00%)
    16 / 52 (30.77%)
         occurrences all number
    18
    18
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract disorders
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 50 (10.00%)
    8 / 52 (15.38%)
         occurrences all number
    6
    13
    Hepatobiliary disorders
    Hepatobiliary disorders
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed [1]
    8 / 48 (16.67%)
    7 / 44 (15.91%)
         occurrences all number
    26
    26
    Skin and subcutaneous tissue disorders
    Skin disorders
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 50 (10.00%)
    2 / 52 (3.85%)
         occurrences all number
    5
    2
    Infections and infestations
    Infection
    alternative dictionary used: NCI CTCAE 4.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 50 (22.00%)
    13 / 52 (25.00%)
         occurrences all number
    14
    21
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Documentation of hepatobiliary disorders was introduced with an amendment of the case report form concerning acute AEs 3 months after start of recruitment. Thus, a small number of patients have no documented information about these AEs.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2012
    Updated procedures for cases of peripheral neuropathy and PML, updated contact information for reporting of SAEs and pregnancies, added information on product complaints, reduction of obligatory pause between prephase and start of treatment from 7 to 2 days
    16 Sep 2013
    Addition of adverse reaction "acute pancreatitis" to the ICF following important drug warning for brentuximab vedotin, updated IB
    04 Feb 2014
    Adaption of the reference level for the evaluation of PET for radiotherapy recommendation

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29133014
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