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    Clinical Trial Results:
    A Phase II, Multi-centre Study Investigating the Safety and Efficacy of Ofatumumab and Bendamustine Combination in Patients with Untreated or Relapsed Chronic Lymphocytic Leukaemia (CLL) Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2011-005178-43
    Trial protocol
    		 CZ   DE   BE   ES   PL   GR   IT  
    Global end of trial date
    25 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2018
    First version publication date
    06 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    115991/COMB157B2201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01520922
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Novartis Pharma AG, CH-4002, Switzerland, Basel
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    25 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To evaluate the investigator-assessed overall response rate (ORR) in two study populations i.e., subjects with previously untreated chronic lymphocytic leukemia (CLL) and subjects with relapsed CLL who were administered ofatumumab and bendamustine.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 36 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Greece: 10
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    97
    EEA total number of subjects
    69
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    41
    From 65 to 84 years
    55
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants (par.) who met eligibility criteria at Screening were then allocated to one of the following populations: par. with previously untreated CLL or par. with relapsed CLL. A total of 99 par. were enrolled and 97 par. entered the treatment period. Study results do not include the 2 par. that were not treated in this study

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ofatumumab + Bendamustine 90 mg/m^2
    Arm description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group. Bendamustine was provided to sites as single-use 25 mg (2.5 mg/mL) and 100 mg (2.5 mg/mL) vials of bendamustine HCl as lyophilized powder.

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells

    Arm title
    		 Ofatumumab + Bendamustine 70 mg/m^2
    Arm description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group. Bendamustine was provided to sites as single-use 25 mg (2.5 mg/mL) and 100 mg (2.5 mg/mL) vials of bendamustine HCl as lyophilized powder.

    Number of subjects in period 1
    		Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Started
    44
    53
    Completed
    39
    45
    Not completed
    5
    8
         Physician decision
    2
    1
         Adverse event, non-fatal
    3
    5
         Progression
    -
    2
    Period 2
    Period 2 title
    Follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ofatumumab + Bendamustine 90 mg/m^2
    Arm description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group. Bendamustine was provided to sites as single-use 25 mg (2.5 mg/mL) and 100 mg (2.5 mg/mL) vials of bendamustine HCl as lyophilized powder.

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells

    Arm title
    		 Ofatumumab + Bendamustine 70 mg/m^2
    Arm description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group. Bendamustine was provided to sites as single-use 25 mg (2.5 mg/mL) and 100 mg (2.5 mg/mL) vials of bendamustine HCl as lyophilized powder.

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells

    Number of subjects in period 2
    		Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Started
    39
    45
    Completed
    39
    44
    Not completed
    0
    1
         Lost to follow-up
    -
    1
    Period 3
    Period 3 title
    Survival follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ofatumumab + Bendamustine 90 mg/m^2
    Arm description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group. Bendamustine was provided to sites as single-use 25 mg (2.5 mg/mL) and 100 mg (2.5 mg/mL) vials of bendamustine HCl as lyophilized powder.

    Arm title
    		 Ofatumumab + Bendamustine 70 mg/m^2
    Arm description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ofatumumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ofatumumab is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells

    Investigational medicinal product name
    Bendamustine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravascular use
    Dosage and administration details
    Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group. Bendamustine was provided to sites as single-use 25 mg (2.5 mg/mL) and 100 mg (2.5 mg/mL) vials of bendamustine HCl as lyophilized powder.

    Number of subjects in period 3 [1]
    		Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Started
    21
    40
    Completed
    20
    40
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Data for survival follow up not available for entire cohort

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ofatumumab + Bendamustine 90 mg/m^2
    Reporting group description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Reporting group title
    Ofatumumab + Bendamustine 70 mg/m^2
    Reporting group description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Reporting group values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2 Total
    Number of subjects
    		 44 53 97
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ( 10.11 ) 66.5 ( 9.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 15 17 32
        Male
    		 29 36 65
    RaceEthnicityOther
    Units: Subjects
        White - White/Caucasian/European Heritage
    		 42 53 95
        White - Arabic/North African Heritage
    		 1 0 1
        African American/African Heritage
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Ofatumumab + Bendamustine 90 mg/m^2
    Reporting group description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Reporting group title
    Ofatumumab + Bendamustine 70 mg/m^2
    Reporting group description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Reporting group title
    Ofatumumab + Bendamustine 90 mg/m^2
    Reporting group description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Reporting group title
    Ofatumumab + Bendamustine 70 mg/m^2
    Reporting group description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
    Reporting group title
    Ofatumumab + Bendamustine 90 mg/m^2
    Reporting group description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Reporting group title
    Ofatumumab + Bendamustine 70 mg/m^2
    Reporting group description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Primary: Number of participants with overall response (OR), as assessed by the investigator

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    End point title
    		 Number of participants with overall response (OR), as assessed by the investigator
    End point description
    OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.
    End point type
    Primary
    End point timeframe
    From the start of study treatment until 3 months after the last dose of study treatment
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [1]
    53 [2]
    Units: Participants
        CR
    19
    6
        CRi
    2
    2
        nPR
    4
    8
        PR
    17
    23
    Notes
    [1] - As-treated subjects (ATS) Population
    [2] - As-treated subjects (ATS) Population
    Statistical analysis title
    		 Investigator-assessed ORR: Untreated CLL
    Comparison groups
    Ofatumumab + Bendamustine 90 mg/m^2 v Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Percentage of participants
    Point estimate
    95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 84.53
         upper limit
    		 99.44
    Statistical analysis title
    		 Investigator-assessed ORR: Relapsed CLL
    Comparison groups
    Ofatumumab + Bendamustine 70 mg/m^2 v Ofatumumab + Bendamustine 90 mg/m^2
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage of participants
    Point estimate
    74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.67
         upper limit
    		 84.74

    Secondary: Number of participants with overall response (OR) with Computed Tomography (CT) Scan (CT scan) assessment, as assessed by the investigator

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    End point title
    		 Number of participants with overall response (OR) with Computed Tomography (CT) Scan (CT scan) assessment, as assessed by the investigator
    End point description
    OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until 3 months after the last dose of study treatment
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [3]
    53 [4]
    Units: Participants
        CR
    12
    5
        CRi
    1
    2
        nPR
    2
    6
        PR
    22
    24
    Notes
    [3] - As-treated subjects (ATS) Population
    [4] - As-treated subjects (ATS) Population
    No statistical analyses for this end point

    Secondary: Number of participants with complete response (CR) with and without a CT scan assessment after the last dose of study treatment, as assessed by the investigator

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    End point title
    		 Number of participants with complete response (CR) with and without a CT scan assessment after the last dose of study treatment, as assessed by the investigator
    End point description
    Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500/µL, platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 g/dL, lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until 3 months after the last dose of study treatment
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [5]
    53 [6]
    Units: Participants
        CR without CT scan assessment
    19
    6
        CR with CT scan assessment
    12
    5
    Notes
    [5] - As-treated subjects (ATS) Population
    [6] - As-treated subjects (ATS) Population
    No statistical analyses for this end point

    Secondary: Investigator-assessed Kaplan-meier estimates of Time to response

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    End point title
    		 Investigator-assessed Kaplan-meier estimates of Time to response
    End point description
    Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11.0 g/dL or 50% improvement over BL, LC <4000/µL.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    43 [7]
    47 [8]
    Units: Months
        median (confidence interval 95%)
    0.95 (0.95 to 1.02)
    1.08 (0.95 to 1.87)
    Notes
    [7] - ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.
    [8] - ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.
    No statistical analyses for this end point

    Secondary: Investigator-assessed Kaplan-meier estimates of duration of response

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    End point title
    		 Investigator-assessed Kaplan-meier estimates of duration of response
    End point description
    The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.
    End point type
    Secondary
    End point timeframe
    From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    20 [9]
    35
    Units: Months
        median (confidence interval 95%)
    35.15 (33.05 to 37.13)
    21.75 (14.75 to 26.41)
    Notes
    [9] - ATS Population only with an initial response with PD or death were assessed for duration of response
    No statistical analyses for this end point

    Secondary: Investigator-assessed of Kaplan-meier estimates of Progression-free survival (PFS)

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    End point title
    		 Investigator-assessed of Kaplan-meier estimates of Progression-free survival (PFS)
    End point description
    PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by >=50% from BL in LC, Ly, size of liver and spleen, PL >= 50% decrease from BL, or to <100,000/uL secondary to CLL, Hb decrease of >2 g/dL from BL or to <10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    20 [10]
    39 [11]
    Units: Months
        median (confidence interval 95%)
    36.07 (34 to 38.05)
    22.54 (14 to 27.33)
    Notes
    [10] - All Treated Subjects’ (ATS) population. N= Progression or Death
    [11] - All Treated Subjects’ (ATS) population. N= Progression or Death
    No statistical analyses for this end point

    Secondary: Investigator-assessed Kaplan-meier estimates of Overall Survival

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    End point title
    		 Investigator-assessed Kaplan-meier estimates of Overall Survival
    End point description
    OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    3 [12]
    23 [13]
    Units: Months
        median (confidence interval 95%)
    99999.9 (-99999.9 to 999999.9)
    99999.9 (-99999.9 to 999999.9)
    Notes
    [12] - Median was not available because over 50% of the all treated subjects were alive. N= Death
    [13] - Median was not available because over 50% of the all treated subjects were alive. N= Death
    No statistical analyses for this end point

    Secondary: Investigator-Assessed Kaplan-Meier Estimates of Time to Progression

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    End point title
    		 Investigator-Assessed Kaplan-Meier Estimates of Time to Progression
    End point description
    Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    19 [14]
    35 [15]
    Units: Months
        median (confidence interval 95%)
    36 (34 to 38.05)
    22.67 (16.07 to 28.58)
    Notes
    [14] - All treated subjects (ATS). This analysis includes patients who had progression.
    [15] - All treated subjects (ATS). This analysis includes patients who had progression.
    No statistical analyses for this end point

    Secondary: Time to next therapy

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    End point title
    		 Time to next therapy
    End point description
    Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    14 [16]
    29 [17]
    Units: Months
        median (confidence interval 95%)
    31.18 (17.25 to 37.03)
    16.82 (11.6 to 25.36)
    Notes
    [16] - ATS Population. Only participants that took anti-CLL therapy were evaluated.
    [17] - ATS Population. Only participants that took anti-CLL therapy were evaluated.
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse event (AE) or serious adverse event (SAE)

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    End point title
    		 Number of participants with any adverse event (AE) or serious adverse event (SAE)
    End point description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [18]
    53 [19]
    Units: Participants
        Any AE
    43
    50
        Any SAE
    20
    25
    Notes
    [18] - Safety Population: all participants who received at least one dose of ofatumumab or bendamustine
    [19] - Safety Population: all participants who received at least one dose of ofatumumab or bendamustine
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Immunoglobulin (Ig) antibodies to End of study treatment

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    End point title
    		 Change from Baseline in the Immunoglobulin (Ig) antibodies to End of study treatment
    End point description
    Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline and end of study treatment (up to 30 months)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    38 [20]
    43 [21]
    Units: Gram per liter
    arithmetic mean (standard deviation)
        IgA
    0.0768 ( 0.91109 )
    0.054 ( 0.23643 )
        IgG
    -0.714 ( 3.0614 )
    -1.246 ( 5.3194 )
        IgM
    -0.049 ( 0.29267 )
    -0.0463 ( 0.16294 )
    Notes
    [20] - Safety Population. Only participants who were available at the indicated time points were analyzed
    [21] - Safety Population. Only participants who were available at the indicated time points were analyzed
    No statistical analyses for this end point

    Secondary: Change from Baseline in cluster of differentiation (CD) CD5+CD19+ cell counts up to 36 months

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    End point title
    		 Change from Baseline in cluster of differentiation (CD) CD5+CD19+ cell counts up to 36 months
    End point description
    CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+ CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [22]
    53 [23]
    Units: Cell per microliter
    arithmetic mean (standard deviation)
        3 month F/U - Baseline (n=32, 31)
    -72622.5 ( 104175.69 )
    -40644.2 ( 36183.14 )
        6 month F/U - Baseline (n=30,28)
    -61258.2 ( 42645.75 )
    -45630.4 ( 40130.68 )
        9 month F/U - Baseline (n=37,23)
    -76688.7 ( 99375.55 )
    -49527.3 ( 40728.82 )
        12 month F/U - Baseline (n=32,23)
    -77884.8 ( 106795.41 )
    -43994.3 ( 39165.64 )
        15 month F/U - Baseline (n=29,21)
    -80997.6 ( 108950.32 )
    -39985.6 ( 36456.16 )
        18 month F/U - Baseline (n=23,11)
    -85837.7 ( 120525.82 )
    -31229.5 ( 28486.65 )
        21 month F/U - Baseline (n=17,8)
    -82180.6 ( 138188.36 )
    -52665.1 ( 42250.59 )
        24 month F/U - Baseline (n=15,7)
    -92850.6 ( 144547.27 )
    -37969.3 ( 26444.26 )
        27 month F/U - Baseline (n=19, 6)
    -82553.4 ( 129930.36 )
    -24824.8 ( 23700.4 )
        30 month F/U - Baseline (n=15, 6)
    -96903.7 ( 142080.38 )
    -30938 ( 28108.7 )
        33 month F/U - Baseline (n=10, 3)
    -65321.8 ( 40537.06 )
    -38216.3 ( 24864.31 )
        36 month F/U - Baseline (n=8, 4)
    -52087.1 ( 35735.07 )
    -30961 ( 25003.73 )
    Notes
    [22] - ATS Population. Only participants with data available at the specified time points were analyzed
    [23] - ATS Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Change from Baseline in cluster of differentiation (CD) CD5-CD19+ cell counts up to 36 months

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    End point title
    		 Change from Baseline in cluster of differentiation (CD) CD5-CD19+ cell counts up to 36 months
    End point description
    CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5- CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [24]
    53 [25]
    Units: Cell per microliter
    arithmetic mean (standard deviation)
        3 month F/U - Baseline (n= 32, 31)
    -5800.8 ( 12693.09 )
    -2052.4 ( 5243.64 )
        6 month F/U - Baseline (n= 30, 28)
    -3921.1 ( 6959.2 )
    -3822.8 ( 8449.8 )
        9 month F/U - Baseline (n= 37, 23)
    -5969.7 ( 12277.21 )
    -2288.4 ( 5724.47 )
        12 month F/U - Baseline (n= 32, 23)
    -6756.8 ( 13009.04 )
    -4656.3 ( 9087.98 )
        15 month F/U - Baseline (n= 29, 21)
    -5323.6 ( 8727.91 )
    -4256.2 ( 9145.23 )
        18 month F/U - Baseline (n= 23, 11)
    -4677.9 ( 7677.12 )
    -5043.6 ( 10927.98 )
        21 month F/U - Baseline (n= 17, 8)
    -5224.2 ( 8477.84 )
    -275.1 ( 449.28 )
        24 month F/U - Baseline (n= 15, 7)
    -4522.7 ( 7562.59 )
    -224 ( 447.47 )
        27 month F/U - Baseline (n= 19, 6)
    -7259 ( 10162.96 )
    -3870.5 ( 8960.8 )
        30 month F/U - Baseline (n= 15, 6)
    -7673.6 ( 10238.82 )
    -3964.3 ( 8918.4 )
        33 month F/U - Baseline (n= 10, 3)
    -9511.2 ( 11834.25 )
    -206 ( 215.84 )
        36 month F/U - Baseline (n= 8, 4)
    -8430.1 ( 13019.82 )
    -5693 ( 10969 )
    Notes
    [24] - ATS Population. Only participants with data available at the specified time points were analyzed
    [25] - ATS Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants who were negative or positive for minimal residual disease (MRD) and achieved a bone marrow biopsy confirmed complete response (CR) up to 36-Month Follow-up

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    End point title
    		 Number of participants who were negative or positive for minimal residual disease (MRD) and achieved a bone marrow biopsy confirmed complete response (CR) up to 36-Month Follow-up
    End point description
    MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.
    End point type
    Secondary
    End point timeframe
    3 month follow up to the 36 Month Follow-up (in 3 month interval)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    16 [26]
    4 [27]
    Units: Participants
        3 month F/U, MRD Positive (n=16 , 4)
    7
    4
        3 month F/U, MRD Negative (n=16 , 4)
    9
    0
        6 month F/U, MRD Positive (n=8 , 2)
    1
    1
        6 month F/U, MRD Negative (n=8 , 2)
    7
    1
        9 month F/U, MRD Positive (n=11 , 2)
    3
    1
        9 month F/U, MRD Negative (n=11 , 2)
    8
    1
        12 month F/U, MRD Positive (n=9 , 2)
    1
    1
        12 month F/U, MRD Negative (n=9 , 2)
    8
    1
        15 month F/U, MRD Positive (n=9 , 2)
    3
    1
        15 month F/U, MRD Negative (n=9 , 2)
    6
    1
        18 month F/U, MRD Positive (n=6 , 1)
    1
    0
        18 month F/U, MRD Negative (n=6 , 1)
    5
    1
        21 month F/U, MRD Positive (n=7, 1)
    2
    0
        21 month F/U, MRD Negative (n=7 , 1)
    5
    1
        24 month F/U, MRD Positive (n=6 , 1)
    0
    0
        24 month F/U, MRD Negative (n=6 , 1)
    6
    1
        27 month F/U, MRD Positive (n=3 , 1)
    0
    0
        27 month F/U, MRD Negative (n=3 , 1)
    3
    1
        30 month F/U, MRD Positive (n=4 , 1)
    1
    0
        30 month F/U, MRD Negative (n=4 , 1)
    3
    1
        33 month F/U, MRD Positive (n=4 , 1)
    1
    0
        33 month F/U, MRD Negative (n=4 , 1)
    3
    1
        36 month F/U, MRD Positive (n=2 , 1)
    0
    0
        36 month F/U, MRD Negative (n=2 , 1)
    2
    1
    Notes
    [26] - ATS Population. Number of subjects who had CR with bone marrow confirmation are included
    [27] - ATS Population. Number of subjects who had CR with bone marrow confirmation are included
    No statistical analyses for this end point

    Secondary: Number of participants who received no transfusion or at least one transfusion during the study

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    End point title
    		 Number of participants who received no transfusion or at least one transfusion during the study
    End point description
    Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.
    End point type
    Secondary
    End point timeframe
    From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [28]
    53 [29]
    Units: Participants
        No transfusions
    38
    33
        At least one transfusion
    6
    20
    Notes
    [28] - Safety Population: All subjects who receive at least one dose of study medication.
    [29] - Safety Population: All subjects who receive at least one dose of study medication.
    No statistical analyses for this end point

    Secondary: Number of participants with autoimmune hemolytic anaemia (AIHA) disease

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    End point title
    		 Number of participants with autoimmune hemolytic anaemia (AIHA) disease
    End point description
    AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [30]
    53 [31]
    Units: Participants
    0
    1
    Notes
    [30] - Safety Population: All subjects who receive at least one dose of study medication.
    [31] - Safety Population: All subjects who receive at least one dose of study medication.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia), as assessed by the investigator

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    End point title
    		 Number of participants with the indicated Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia), as assessed by the investigator
    End point description
    Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).
    End point type
    Secondary
    End point timeframe
    From the first dose of study medication to 60 days after the last dose of study medication
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [32]
    53 [33]
    Units: Participants
        Neutropenia/Febrile neutropenia, Grade 3
    8
    27
        Neutropenia/Febrile Neutropenia, Grade 4
    9
    16
        Thrombocytopenia, Grade 3
    1
    2
        Thrombocytopenia, Grade 4
    0
    2
        Anemia, Grade 3
    1
    0
        Anemia, Grade 4
    0
    0
    Notes
    [32] - From the first dose of study medication to 60 days after the last dose of study medication
    [33] - From the first dose of study medication to 60 days after the last dose of study medication
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Grade 3 or Grade 4 adverse event of infection

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    End point title
    		 Number of participants with the indicated Grade 3 or Grade 4 adverse event of infection
    End point description
    Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).
    End point type
    Secondary
    End point timeframe
    From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [34]
    53 [35]
    Units: Participants
    5
    10
    Notes
    [34] - Safety Population: All subjects who receive at least one dose of study medication.
    [35] - Safety Population: All subjects who receive at least one dose of study medication.
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated constitutional or B-symptoms

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    End point title
    		 Number of participants with the indicated constitutional or B-symptoms
    End point description
    Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.
    End point type
    Secondary
    End point timeframe
    Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [36]
    53 [37]
    Units: Participants
        SCR, night sweats, n =44, 52
    19
    22
        SCR, weight loss, n=44, 52
    4
    5
        SCR, fever, n=44, 52
    1
    2
        SCR, extreme fatigue, n=44, 52
    14
    15
        C3D1, night sweats, n =42, 49
    5
    2
        C3D1, weight loss, n=42, 49
    0
    2
        C3D1, fever, n=42, 49
    0
    0
        C3D1, extreme fatigue, n=42, 49
    2
    4
        C6D1, night sweats, n =39, 47
    0
    1
        C6D1, weight loss, n =39, 47
    0
    0
        C6D1, fever, n =39, 47
    0
    0
        C6D1, extreme fatigue, n =39, 47
    0
    1
        12 Month F/U, night sweats, n =39, 29
    0
    0
        12 Month F/U, weight loss, n =39, 29
    1
    0
        12 Month F/U, fever, n =39, 29
    0
    0
        12 Month F/U, extreme fatigue, n =39, 29
    0
    0
        24 Month F/U, night sweats, n =29, 17
    0
    0
        24 Month F/U, weight loss, n=29, 17
    0
    0
        24 Month F/U, fever, n=29, 17
    0
    0
        24 Month F/U, extreme fatigue, n=29, 17
    1
    0
        36 Month F/U, night sweats, n =21, 9
    0
    0
        36 Month F/U, weight loss, n=21, 9
    0
    0
        36 Month F/U, fever, n=21, 9
    0
    0
        36 Month F/U, extreme fatigue, n=21, 9
    0
    0
    Notes
    [36] - Safety population: Only participants with data available at the specified time points were analyzed
    [37] - Safety population: Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated eastern cooperative oncology group (ECOG) performance status (PS)

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    End point title
    		 Number of participants with the indicated eastern cooperative oncology group (ECOG) performance status (PS)
    End point description
    The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.
    End point type
    Secondary
    End point timeframe
    Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [38]
    53 [39]
    Units: Participants
        BL, Score of 0, n=44, 53
    16
    23
        BL, Score of 1, n=44, 53
    28
    29
        BL, Score of 2, n=44, 53
    0
    1
        BL, Score of 3, n=44, 53
    0
    0
        BL, Score of 4-5, n=44, 53
    0
    0
        C3D1, Score of 0, n=42, 48
    17
    27
        C3D1, Score of 1, n=42, 48
    25
    21
        C3D1, Score of 2, n=42, 48
    0
    0
        C3D1, Score of 3, n=42, 48
    0
    0
        C3D1, Score of 4-5, n=42, 48
    0
    0
        C6D1, Score of 0, n=38, 47
    19
    27
        C6D1, Score of 1, n=38, 47
    19
    19
        C6D1, Score of 2, n=38, 47
    0
    1
        C6D1, Score of 3, n=38, 47
    0
    0
        C6D1, Score of 4-5, n=38, 47
    0
    0
        12 Month F/U, Score of 0, n=39, 28
    24
    19
        12 Month F/U, Score of 1, n=39, 28
    14
    8
        12 Month F/U, Score of 2, n=39, 28
    1
    1
        12 Month F/U, Score of 3, n=39, 28
    0
    0
        12 Month F/U, Score of 4-5, n=39, 28
    0
    0
        24 Month F/U, Score of 0, n=28, 16
    16
    13
        24 Month F/U, Score of 1, n=28, 16
    11
    3
        24 Month F/U, Score of 2, n=28, 16
    1
    0
        24 Month F/U, Score of 3, n=28, 16
    0
    0
        24 Month F/U, Score of 4-5, n=28, 16
    0
    0
        36 Month F/U, Score of 0, n=21, 9
    15
    8
        36 Month F/U, Score of 1, n=21, 9
    5
    1
        36 Month F/U, Score of 2, n=21, 9
    1
    0
        36 Month F/U, Score of 3, n=21, 9
    0
    0
        36 Month F/U, Score of 4-5, n=21, 9
    0
    0
    Notes
    [38] - Safety population: Only participants with data available at the specified time points were analyzed
    [39] - Safety population: Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with confirmed positive response for human anti-human Antibodies (HAHA) at the indicated time points

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    End point title
    		 Number of participants with confirmed positive response for human anti-human Antibodies (HAHA) at the indicated time points
    End point description
    The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [40]
    53 [41]
    Units: Participants
        C1D1, n=41, 53
    0
    0
        C6D1, n=34, 43
    0
    0
        6-Month F/U, n=35, 37
    0
    0
        Any post dose time, n=42, 47
    0
    0
    Notes
    [40] - Safety population: Only participants with data available at the specified time points were analyzed
    [41] - Safety population: Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Maximum decrease in sum of the product of the diameter (SPD) from Baseline in participants with lymphadenopathy at Baseline

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    End point title
    		 Maximum decrease in sum of the product of the diameter (SPD) from Baseline in participants with lymphadenopathy at Baseline
    End point description
    Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter [SPD]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [42]
    53 [43]
    Units: cm^2 (centimeters squared)
    arithmetic mean (standard deviation)
        C2D1, n=34, 35
    -83.5 ( 23.69 )
    -77.3 ( 31.62 )
        C3D1, n=32, 35
    -92.1 ( 20.17 )
    -90.9 ( 17.18 )
        C4D1, n=32, 35
    -99.1 ( 2.67 )
    -94.6 ( 11.56 )
        C5D1, n=29, 35
    -99.6 ( 1.22 )
    -96.2 ( 8.95 )
        C6D1, n=30, 33
    -99.6 ( 2.28 )
    -97 ( 7.78 )
        3-Month F/U, n=33, 32
    -99.2 ( 3.64 )
    -95.9 ( 19.17 )
        6-Month F/U, n=3, 1
    -100 ( 0 )
    -100 ( 99999.999 )
        9-Month F/U, n=1, 0
    -68.4 ( 99999.999 )
    99999.99 ( 99999.99 )
    Notes
    [42] - Safety population: Only participants with data available at the specified time points were analyzed
    [43] - Safety population: Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated reduction in organomegaly (spleen and liver)

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    End point title
    		 Number of participants with the indicated reduction in organomegaly (spleen and liver)
    End point description
    Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).
    End point type
    Secondary
    End point timeframe
    Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [44]
    53 [45]
    Units: Participants
        SCR, S, NOR, n=44, 50
    23
    31
        SCR, S, EL, n=44, 50
    21
    19
        SCR, S, NOA, n=44, 50
    0
    0
        SCR, L, NOR, n=44, 51
    38
    41
        SCR, L, EL, n=44, 51
    6
    9
        SCR, L, NOA, n=44, 51
    0
    1
        C3D1, S, NOR, n=42, 48
    37
    41
        C3D1, S, EL, n=42, 48
    5
    6
        C3D1, S, NOA, n=42, 48
    0
    1
        C3D1, L, NOR, n=42, 48
    38
    42
        C3D1, L, EL, n=42, 48
    4
    5
        C3D1, L, NOA, n=42, 48
    0
    1
        C6D1, S, NOR, n=39, 46
    39
    43
        C6D1, S, EL, n=39, 46
    0
    2
        C6D1, S, NOA, n=39, 46
    0
    1
        C6D1, L, NOR, n=39, 46
    37
    44
        C6D1, L, EL, n=39, 46
    2
    0
        C6D1, L, NOA, n=39, 46
    0
    2
        12 Month F/U, S, NOR, n=39, 29
    39
    28
        12 Month F/U, S, EL, n=39, 29
    0
    1
        12 Month F/U, S, NOA, n=39, 29
    0
    0
        12 Month F/U, L, NOR, n=39, 29
    38
    28
        12 Month F/U, L, EL, n=39, 29
    1
    1
        12 Month F/U, L, NOA, n=39, 29
    0
    0
        24 Month F/U, S, NOR, n=29, 17
    29
    16
        24 Month F/U, S, EL, n=29, 17
    0
    1
        24 Month F/U, S, NOA, n=29, 17
    0
    0
        24 Month F/U, L, NOR, n=29, 17
    29
    16
        24 Month F/U, L, EL, n=29, 17
    0
    1
        24 Month F/U, L, NOA, n=29, 17
    0
    0
        36 Month F/U, S, NOR, n=21, 9
    21
    9
        36 Month F/U, S, EL, n=21, 9
    0
    0
        36 Month F/U, S, NOA, n=21, 9
    0
    0
        36 Month F/U, L, NOR, n=21, 9
    21
    9
        36 Month F/U, L, EL, n=21, 9
    0
    0
        36 Month F/U, L, NOA, n=21, 9
    0
    0
    Notes
    [44] - Safety Population. Only participants with data available at the specified time points were analyzed
    [45] - Safety Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated cytogenetics testing at Baseline who also had a clinical response after last dose of study treatment

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    End point title
    		 Number of participants with the indicated cytogenetics testing at Baseline who also had a clinical response after last dose of study treatment
    End point description
    Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [46]
    53 [47]
    Units: Participants
        17p-, CR, n=2, 6
    0
    0
        17p-, CRi, n=2, 6
    0
    0
        17p-, nPR, n=2, 6
    0
    0
        17p-, PR, n=2, 6
    0
    1
        17p-, SD, n=2, 6
    1
    3
        17p-, PD, n=2, 6
    0
    2
        11q-, CR, n=8, 15
    3
    1
        11q-, CRi, No, n=8, 15
    0
    0
        11q-, nPR, n=8, 15
    1
    3
        11q-, PR, n=8, 15
    4
    7
        11q-, SD, n=8, 15
    0
    1
        11q-, PD, n=8, 15
    0
    3
        17p- or 11q-, CR, n=10, 20
    3
    1
        17p- or 11q-, CRi, n=10, 20
    0
    0
        17p- or 11q-, nPR, n=10, 20
    1
    3
        17p- or 11q-, PR, n=10, 20
    4
    8
        17p- or 11q-, SD, n=10, 20
    1
    3
        17p- or 11q-, PD, n=10, 20
    0
    5
        6q- or +12q or 13q-, CR, n=20, 24
    11
    3
        6q- or +12q or 13q-, CRi, n=20, 24
    1
    2
        6q- or +12q or 13q-, nPR, n=20, 24
    1
    4
        6q- or +12q or 13q-, PR, n=20, 24
    7
    10
        6q- or +12q or 13q-, SD, n=20, 24
    0
    2
        6q- or +12q or 13q-, PD, n=20, 24
    0
    2
        No aberration, CR, n= 14, 8
    5
    2
        No aberration, CRi, n= 14, 8
    2
    0
        No aberration, nPR, n= 14, 8
    3
    1
        No aberration, PR, n= 14, 8
    4
    4
        No aberration, SD, n= 14, 8
    0
    0
        No aberration, PD, n= 14, 8
    0
    1
    Notes
    [46] - Safety Population. Only participants with data available at the specified time points were analyzed
    [47] - Safety Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated Beta 2 microglobulin (B2M) at Baseline who also had a clinical response after the last dose of study treatment

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    End point title
    		 Number of participants with the indicated Beta 2 microglobulin (B2M) at Baseline who also had a clinical response after the last dose of study treatment
    End point description
    Participants with B2M concentration of <=4000 µg/L and >4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [48]
    53 [49]
    Units: Participants
        <= 4000 µg/L, CR, n=23, 24
    9
    3
        <= 4000 µg/L, CRi, n=23, 24
    3
    2
        <= 4000 µg/L, nPR, n=23, 24
    4
    6
        <= 4000 µg/L, PR, n=23, 24
    7
    9
        <= 4000 µg/L, SD, n=23, 24
    0
    2
        <= 4000 µg/L, PD, n=23, 24
    0
    2
        > 4000 µg/L, CR, n=17, 29
    9
    3
        > 4000 µg/L, CRi, n=17, 29
    0
    0
        > 4000 µg/L, nPR, n=17, 29
    1
    2
        > 4000 µg/L, PR, n=17, 29
    6
    14
        > 4000 µg/L, SD, n=17, 29
    0
    3
        > 4000 µg/L, PD, n=17, 29
    0
    6
    Notes
    [48] - ATS Population. Only participants with data available at the specified time points were analyzed
    [49] - ATS Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with the indicated immunoglobulin heavy chain variable region (IgVH) testing at Baseline who also had a clinical response after last dose of study treatment

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    End point title
    		 Number of participants with the indicated immunoglobulin heavy chain variable region (IgVH) testing at Baseline who also had a clinical response after last dose of study treatment
    End point description
    Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [50]
    53 [51]
    Units: Participants
        IgVH Mutated (<=98 %), CR, n=12, 13
    6
    4
        IgVH Mutated (<=98 %), CRi, n=12, 13
    2
    0
        IgVH Mutated (<=98 %), nPR, n=12, 13
    0
    4
        IgVH Mutated (<=98 %), PR, n=12, 13
    4
    2
        IgVH Mutated (<=98 %), SD, n=12, 13
    0
    0
        IgVH Mutated (<=98 %), PD, n=12, 13
    0
    3
        IgVH unmutated (>98%), CR, n=23, 34
    11
    1
        IgVH unmutated (>98%), CRi, n=23, 34
    1
    2
        IgVH unmutated (>98%), nPR, n=23, 34
    5
    4
        IgVH unmutated (>98%), PR, n=23, 34
    5
    18
        IgVH unmutated (>98%), SD, n=23, 34
    0
    5
        IgVH unmutated (>98%), PD, n=23, 34
    0
    3
    Notes
    [50] - ATS Population. Only participants with data available at the specified time points were analyzed
    [51] - ATS Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with zeta-chain-associated protein kinase (ZAP) 70 testing at Baseline who also had a clinical response after last dose of study treatment

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    End point title
    		 Number of participants with zeta-chain-associated protein kinase (ZAP) 70 testing at Baseline who also had a clinical response after last dose of study treatment
    End point description
    ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.
    End point type
    Secondary
    End point timeframe
    From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    36 [52]
    44 [53]
    Units: Participants
        ZAP-70, Int, CR, n=6, 6
    1
    1
        ZAP-70, Int, CRi, n=6, 6
    0
    0
        ZAP-70, Int, nPR, n=6, 6
    0
    0
        ZAP-70, Int, PR, n=6, 6
    3
    3
        ZAP-70, Int, PD, n=6, 6
    0
    1
        ZAP-70, Int, SD, n=6, 6
    1
    0
        ZAP-70, Neg, CR, n=2, 2
    1
    0
        ZAP-70, Neg, CRi, n=2, 2
    0
    0
        ZAP-70, Neg, nPR, n=2, 2
    0
    0
        ZAP-70, Neg, PR, n=2, 2
    1
    2
        ZAP-70, Neg, PD, n=2, 2
    0
    0
        ZAP-70, Neg, SD, n=2, 2
    0
    0
        ZAP-70, Pos, CR, n=36, 44
    17
    5
        ZAP-70, Pos, CRi, n=36, 44
    3
    2
        ZAP-70, Pos, nPR, n=36, 44
    5
    8
        ZAP-70, Pos, PR, n=36, 44
    11
    17
        ZAP-70, Pos, PD, n=36, 44
    0
    7
        ZAP-70, Pos, SD, n=36, 44
    0
    5
    Notes
    [52] - ATS Population. Only participants with data available at the specified time points were analyzed
    [53] - ATS Population. Only participants with data available at the specified time points were analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with an adverse event of any infusion reactions (IR) or serious infusion reactions (SIR)

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    End point title
    		 Number of participants with an adverse event of any infusion reactions (IR) or serious infusion reactions (SIR)
    End point description
    An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.
    End point type
    Secondary
    End point timeframe
    From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)
    End point values
    		 Ofatumumab + Bendamustine 90 mg/m^2 Ofatumumab + Bendamustine 70 mg/m^2
    Number of subjects analysed
    44 [54]
    53 [55]
    Units: Participants
        Any ofatumumab only IR
    30
    34
        Any ofatumumab only SIR
    3
    4
        Any ofatumumab plus bendamustine IR
    30
    35
        Any ofatumumab plus bendamustine SIR
    4
    4
    Notes
    [54] - Safety Population: All subjects who receive at least one dose of study medication.
    [55] - Safety Population: All subjects who receive at least one dose of study medication.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse events are reported in this record from First Patient First Treatment until Last Patient Last Visit.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Ofatumumab + Bendamustine 70mg/m^2
    Reporting group description
    		 Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Reporting group title
    Ofatumumab + Bendamustine 90mg/m^2
    Reporting group description
    		 Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).

    Serious adverse events
    		 Ofatumumab + Bendamustine 70mg/m^2 Ofatumumab + Bendamustine 90mg/m^2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 53 (47.17%)
    20 / 44 (45.45%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 53 (0.00%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (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
    Anaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 44 (4.55%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 44 (6.82%)
         occurrences causally related to treatment / all
    5 / 5
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type IV hypersensitivity reaction
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 53 (1.89%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 53 (3.77%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 53 (3.77%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Aspergillus infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelothrix infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 53 (1.89%)
    0 / 44 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 44 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ofatumumab + Bendamustine 70mg/m^2 Ofatumumab + Bendamustine 90mg/m^2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 53 (92.45%)
    40 / 44 (90.91%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    5 / 53 (9.43%)
    1 / 44 (2.27%)
         occurrences all number
    6
    1
    Phlebitis
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 44 (11.36%)
         occurrences all number
    4
    6
    Chills
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 44 (11.36%)
         occurrences all number
    4
    5
    Fatigue
         subjects affected / exposed
    8 / 53 (15.09%)
    7 / 44 (15.91%)
         occurrences all number
    10
    8
    Malaise
         subjects affected / exposed
    4 / 53 (7.55%)
    0 / 44 (0.00%)
         occurrences all number
    4
    0
    Oedema peripheral
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 44 (6.82%)
         occurrences all number
    5
    8
    Pyrexia
         subjects affected / exposed
    8 / 53 (15.09%)
    10 / 44 (22.73%)
         occurrences all number
    13
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 53 (7.55%)
    3 / 44 (6.82%)
         occurrences all number
    4
    3
    Dyspnoea
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 44 (11.36%)
         occurrences all number
    3
    6
    Oropharyngeal pain
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 53 (3.77%)
    6 / 44 (13.64%)
         occurrences all number
    3
    7
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    3 / 53 (5.66%)
    3 / 44 (6.82%)
         occurrences all number
    3
    3
    Weight decreased
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    8 / 53 (15.09%)
    3 / 44 (6.82%)
         occurrences all number
    15
    24
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 44 (11.36%)
         occurrences all number
    4
    6
    Headache
         subjects affected / exposed
    6 / 53 (11.32%)
    6 / 44 (13.64%)
         occurrences all number
    8
    10
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 53 (9.43%)
    5 / 44 (11.36%)
         occurrences all number
    5
    5
    Neutropenia
         subjects affected / exposed
    32 / 53 (60.38%)
    20 / 44 (45.45%)
         occurrences all number
    62
    50
    Thrombocytopenia
         subjects affected / exposed
    12 / 53 (22.64%)
    7 / 44 (15.91%)
         occurrences all number
    16
    11
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 44 (4.55%)
         occurrences all number
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    4 / 53 (7.55%)
    5 / 44 (11.36%)
         occurrences all number
    5
    9
    Constipation
         subjects affected / exposed
    5 / 53 (9.43%)
    6 / 44 (13.64%)
         occurrences all number
    6
    9
    Diarrhoea
         subjects affected / exposed
    7 / 53 (13.21%)
    5 / 44 (11.36%)
         occurrences all number
    8
    7
    Nausea
         subjects affected / exposed
    16 / 53 (30.19%)
    19 / 44 (43.18%)
         occurrences all number
    21
    27
    Vomiting
         subjects affected / exposed
    4 / 53 (7.55%)
    5 / 44 (11.36%)
         occurrences all number
    5
    7
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 44 (6.82%)
         occurrences all number
    5
    3
    Erythema
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 44 (6.82%)
         occurrences all number
    5
    3
    Pruritus
         subjects affected / exposed
    4 / 53 (7.55%)
    7 / 44 (15.91%)
         occurrences all number
    6
    7
    Rash
         subjects affected / exposed
    7 / 53 (13.21%)
    12 / 44 (27.27%)
         occurrences all number
    9
    20
    Urticaria
         subjects affected / exposed
    3 / 53 (5.66%)
    6 / 44 (13.64%)
         occurrences all number
    4
    10
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 53 (3.77%)
    4 / 44 (9.09%)
         occurrences all number
    2
    4
    Back pain
         subjects affected / exposed
    3 / 53 (5.66%)
    5 / 44 (11.36%)
         occurrences all number
    3
    5
    Bone pain
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 44 (6.82%)
         occurrences all number
    0
    6
    Pain in extremity
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 44 (2.27%)
         occurrences all number
    3
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 53 (5.66%)
    2 / 44 (4.55%)
         occurrences all number
    4
    2
    Herpes simplex
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 44 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 44 (2.27%)
         occurrences all number
    4
    1
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 44 (6.82%)
         occurrences all number
    5
    3
    Urinary tract infection
         subjects affected / exposed
    2 / 53 (3.77%)
    3 / 44 (6.82%)
         occurrences all number
    3
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 53 (9.43%)
    6 / 44 (13.64%)
         occurrences all number
    5
    7

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    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.

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