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    Clinical Trial Results:
    A Phase II, Two Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined with Idelalisib or Venetoclax in Patients with Relapsed or Refractory CLL/SLL Previously Treated with Bruton’s Tyrosine Kinase (BTK) Inhibitor

    Summary
    EudraCT number
    		 2015-002915-14
    Trial protocol
    		 AT   GB   DE   FR   IT  
    Global end of trial date
    01 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2022
    First version publication date
    04 Aug 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MOR208C205
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02639910
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 US IND Number: 114,856
    Sponsors
    Sponsor organisation name
    MorphoSys AG
    Sponsor organisation address
    Semmelweisstr, 7, D-82152 Planegg, Germany,
    Public contact
    Medical Information, MorphoSys AG , +49 1 844 667-199, medinfo@morphosys.com
    Scientific contact
    Medical Information, MorphoSys AG , +49 1 844 667-199, medinfo@morphosys.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the safety and preliminary efficacy of MOR00208 combined with Idelalisib or Venetoclax in patients with relapsed or refractory CLL/SLL previously treated with Bruton’s Tyrosine Kinase (BTK) inhibitor.
    Protection of trial subjects
    Independent Ethics Committee: Prior to site initiation, the sponsor obtained written approval and favorable opinion from the appropriate regulatory bodies/local health authorities (in accordance with local regulations) and the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) to conduct the study in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) and applicable country specific regulatory requirements. Approval was required for the study protocol, Investigator’s Brochure,protocol amendments, Informed Consent Forms (ICFs), and Patient Information Sheets. No substantial changes to the final approved protocol were initiated without the prior written approval and favorable opinion of the IRB/IEC and approval by the regulatory bodies/local health authorities of a written amendment, except when necessary to eliminate immediate hazards to the patients or when the change involves only logistics or administration. Ethical Conduct of the Study: This clinical study was designed, conducted, and reported in accordance with ICH GCP guidelines, applicable local regulations, and with the ethical principles laid down in the Declaration of Helsinki, including, but not limited to: 1) IRB/IEC review and favorable pinion/approval of the study protocol. 2) Patient informed consent. 3) Investigator reporting requirements. The sponsor provided full details of the above procedures, verbally, in writing, or both. Patient information and Consent: Prior to any protocol related activities, the investigator obtained freely given written consent from each patient after an appropriate explanation of the aims, methods, anticipated benefits, potential hazards and any other aspect of the study that was relevant to the patient's decision to participate. The ICF was signed, with name and date noted by the patient, before the patient was exposed to any study related procedure including screening tests for eligibility.
    Background therapy
    		 Patients were allowed to continue the medications that they were taking at baseline. Medications to treat concomitant diseases, e.g., diabetes, hypertension, bronchial asthma, and COPD were allowed. Patients also received therapy to mitigate side effects of the study medication as clinically indicated, as well as best supportive care as per institutional guidelines. This could have included, e.g., antiemetics, antidiarrheals, anticholinergics, antispasmodics, antipyretics, antihistamines, analgesics, antibiotics, and other medications intended to treat symptoms. The investigator had to instruct the patient not to take any additional medications (including over the counter products) during the study without prior consultation. Investigators documented all medications (e.g., prescription drugs, over the counter drugs, herbal or homeopathic remedies, nutritional supplements) taken within 30 days prior to signature of the ICF.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    24
    EEA total number of subjects
    16
    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)
    11
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Age ≥ 18 years. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that met International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria and histologically confirmed. Patients must have relapsed or refractory disease Most recent anticancer therapy with BTK inhibitor (e.g., ibrutinib)

    Pre-assignment
    Screening details
    		 CT/MRI scan had to be performed within 14 days before C1D1. CT scans performed prior to screening as part of the regular clinical workup of the patient was allowed up to 6 weeks before C1D1. tumor lysis syndrome risk assessment as per IWCLL guideline could have been obtained from CLL history or otherwise obtained from baseline investigation.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib
    Arm description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Idelalisib dose: Patients self-administered the starting dose of 150 mg twice daily orally, continuously during the study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tafasitamab
    Investigational medicinal product code
    MOR00208
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 each cycle from C7D1. MOR00208 is a lyophilized powder for reconstitution for intravenous infusion. For administration, MOR00208 was diluted into a commercially available 250 mL infusion container with 0.9% (w/v) sodium chloride for injection. It was used in combination with Idelalisib (100, 150mg tablets).

    Arm title
    		 Cohort B Safety = MOR00208 + Venetoclax
    Arm description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Venetoclax Dose: To mitigate the risk for tumor lysis syndrome (TLS), treatment of patients with oral venetoclax was initiated at a dose of 20 mg daily from C1D8 for 7 days, followed by a weekly ramp-up schedule (50 mg, 100 mg, 200 mg daily dose) to the recommended daily dose of 400 mg, starting from C2D8. Patients self-administered venetoclax throughout the study except for during hospitalization. NOTE: No venetoclax was administered to 2 patients as they had IRR to MOR00208 during the first infusion at C1D1 and study drug treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tafasitamab
    Investigational medicinal product code
    MOR00208
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 each cycle from C7D1. MOR00208 is a lyophilized powder for reconstitution for intravenous infusion. For administration, MOR00208 was diluted into a commercially available 250 mL infusion container with 0.9% (w/v) sodium chloride for injection. It was used in combination with Venetoclax (10, 50, 100mg tablets).

    Number of subjects in period 1
    		Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Safety = MOR00208 + Venetoclax
    Started
    11
    13
    Completed
    11
    13
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib
    Arm description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Idelalisib dose: Patients self-administered the starting dose of 150 mg twice daily orally, continuously during the study NOTE: Treatment with MOR00208 and idelalisib or venetoclax continued for up to 24 cycles or longer at the investigator’s discretion or until documented disease progression, intolerable toxicity, withdrawal of consent to continue study treatment, death, or early termination of the study. Completion has been defined for Period 2 as having completed EOT and 30-day-FU visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tafasitamab
    Investigational medicinal product code
    MOR00208
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 each cycle from C7D1. MOR00208 is a lyophilized powder for reconstitution for intravenous infusion. For administration, MOR00208 was diluted into a commercially available 250 mL infusion container with 0.9% (w/v) sodium chloride for injection. It was used in combination with Idelalisib (100, 150mg tablets).

    Arm title
    		 Cohort B Efficacy = MOR00208 + Venetoclax
    Arm description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Venetoclax Dose: To mitigate the risk for tumor lysis syndrome (TLS), treatment of patients with oral venetoclax was initiated at a dose of 20 mg daily from C1D8 for 7 days, followed by a weekly ramp-up schedule (50 mg,100 mg, 200 mg daily dose) to the recommended daily dose of 400 mg, starting from C2D8. Patients self-administered venetoclax throughout the study except for during hospitalization.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tafasitamab
    Investigational medicinal product code
    MOR00208
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 each cycle from C7D1. MOR00208 is a lyophilized powder for reconstitution for intravenous infusion. For administration, MOR00208 was diluted into a commercially available 250 mL infusion container with 0.9% (w/v) sodium chloride for injection. It was used in combination with Venetoclax (10, 50, 100mg tablets).

    Number of subjects in period 2
    		Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Efficacy = MOR00208 + Venetoclax
    Started
    11
    13
    Completed
    6
    8
    Not completed
    5
    5
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    -
    1
         Progressive Disease
    3
    -
         Not specified
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period 1 Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 13 13
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.9 ( 8.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF included all patients who received at least one dose of any study drug and had at least one post-baseline safety evaluation

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) consisted of all patients who received at least one dose of MOR00208 and/or one dose of idelalisib in Cohort A and/or one dose of venetoclax in Cohort B.

    Subject analysis set title
    PK Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PKAS included all patients who received at least one dose of MOR00208 and had at least one quantifiable serum MOR00208 concentration. In Cohort B, 1 patient had no quantifiable serum MOR00208 concentration and was excluded from the PKAS.

    Subject analysis set title
    Immunogenicity Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The IAS included all patients who had at least one anti-MOR00208 antibody assessment. The reason for exclusion of 1 patient from IAS population was no anti-MOR00208 antibody assessment.

    Subject analysis sets values
    		 Safety analysis set Full analysis set PK Analysis Set Immunogenicity Analysis Set
    Number of subjects
    24
    24
    23
    23
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
        Adults (18-64 years)
    11
    11
    10
    11
        From 65-84 years
    13
    13
    13
    12
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.9 ( 8.5 )
    64.9 ( 8.5 )
    65.3 ( 8.4 )
    64.3 ( 8.1 )
    Gender categorical
    Units: Subjects
        Female
    8
    8
    8
    8
        Male
    16
    16
    15
    15

    End points

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    End points reporting groups
    Reporting group title
    Cohort A Safety and Efficacy = MOR00208 + Idelalisib
    Reporting group description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Idelalisib dose: Patients self-administered the starting dose of 150 mg twice daily orally, continuously during the study

    Reporting group title
    Cohort B Safety = MOR00208 + Venetoclax
    Reporting group description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Venetoclax Dose: To mitigate the risk for tumor lysis syndrome (TLS), treatment of patients with oral venetoclax was initiated at a dose of 20 mg daily from C1D8 for 7 days, followed by a weekly ramp-up schedule (50 mg, 100 mg, 200 mg daily dose) to the recommended daily dose of 400 mg, starting from C2D8. Patients self-administered venetoclax throughout the study except for during hospitalization. NOTE: No venetoclax was administered to 2 patients as they had IRR to MOR00208 during the first infusion at C1D1 and study drug treatment.
    Reporting group title
    Cohort A Safety and Efficacy = MOR00208 + Idelalisib
    Reporting group description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Idelalisib dose: Patients self-administered the starting dose of 150 mg twice daily orally, continuously during the study NOTE: Treatment with MOR00208 and idelalisib or venetoclax continued for up to 24 cycles or longer at the investigator’s discretion or until documented disease progression, intolerable toxicity, withdrawal of consent to continue study treatment, death, or early termination of the study. Completion has been defined for Period 2 as having completed EOT and 30-day-FU visit.

    Reporting group title
    Cohort B Efficacy = MOR00208 + Venetoclax
    Reporting group description
    		 MOR00208 Dose: For the first 3 months of the study, each 28-day cycle consisted of a MOR00208 intravenous infusion of the dose of 12 mg/kg on Day 1, Day 8, Day 15, and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter, MOR00208 was administered on a bi-weekly basis (every 14 days) with infusions on Days 1 and 15 of each cycle from Cycle 4 to 6, and on a monthly basis on Day 1 of each cycle from C7D1. Venetoclax Dose: To mitigate the risk for tumor lysis syndrome (TLS), treatment of patients with oral venetoclax was initiated at a dose of 20 mg daily from C1D8 for 7 days, followed by a weekly ramp-up schedule (50 mg,100 mg, 200 mg daily dose) to the recommended daily dose of 400 mg, starting from C2D8. Patients self-administered venetoclax throughout the study except for during hospitalization.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF included all patients who received at least one dose of any study drug and had at least one post-baseline safety evaluation

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) consisted of all patients who received at least one dose of MOR00208 and/or one dose of idelalisib in Cohort A and/or one dose of venetoclax in Cohort B.

    Subject analysis set title
    PK Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The PKAS included all patients who received at least one dose of MOR00208 and had at least one quantifiable serum MOR00208 concentration. In Cohort B, 1 patient had no quantifiable serum MOR00208 concentration and was excluded from the PKAS.

    Subject analysis set title
    Immunogenicity Analysis Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The IAS included all patients who had at least one anti-MOR00208 antibody assessment. The reason for exclusion of 1 patient from IAS population was no anti-MOR00208 antibody assessment.

    Primary: Incidence of adverse events after combination and single therapy in safety analysis set (SAF)

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    End point title
    		 Incidence of adverse events after combination and single therapy in safety analysis set (SAF) [1]
    End point description
    The Safety analysis set (SAF) included all patients who received at least one dose of MOR00208 and/or one dose of idelalisib or venetoclax. Analyses using the SAF were based on the study drug actually received. The SAF was used for the primary endpoint analysis, i.e., incidence.
    End point type
    Primary
    End point timeframe
    Cycle 1 to EOT (End of treatment).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned.
    End point values
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Safety = MOR00208 + Venetoclax Safety analysis set
    Number of subjects analysed
    11
    13
    24
    Units: Number of subjects
    11
    13
    24
    No statistical analyses for this end point

    Primary: Severity of adverse events after single and combination therapy in safety analysis set (SAF)

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    End point title
    		 Severity of adverse events after single and combination therapy in safety analysis set (SAF) [2]
    End point description
    TEAEs were defined as AEs which began or worsened in severity after the first administration of study drug (MOR00208, Idelalisib or Venetoclax) until 30 days after the last study treatment. AEs that occurred or worsened later than 30 days after the last treatment of any study drug were defined as treatment-emergent if these were suspected to be related to the pertaining study drug. MOR00208-related TEAEs with toxicity Grade 3 or 4 was included based on the number of patients in the safety analysis set.
    End point type
    Primary
    End point timeframe
    Cycle 1 to EOT (End of treatment).
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned.
    End point values
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Safety = MOR00208 + Venetoclax Safety analysis set
    Number of subjects analysed
    11
    13
    24
    Units: Number of subjects
    9
    9
    18
    No statistical analyses for this end point

    Secondary: Best objective response rate (ORR) after combination therapy local evaluation in full analysis set (FAS)

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    End point title
    		 Best objective response rate (ORR) after combination therapy local evaluation in full analysis set (FAS)
    End point description
    Objective response included complete response (CR), Partial response (PR) and Partial response with lymphocytosis (PRL) categories for MOR00208 + Idelalisib and CR and PR categories for MOR00208 + Venetoclax.
    End point type
    Secondary
    End point timeframe
    Cycle 1 to EOT (End of treatment).
    End point values
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Efficacy = MOR00208 + Venetoclax Full analysis set
    Number of subjects analysed
    11
    13
    24
    Units: Number of subjects
    10
    10
    20
    No statistical analyses for this end point

    Secondary: Treatment emergent Anti-MOR00208 antibody formation after combination therapy in immunogenicity analysis set (IAS)

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    End point title
    		 Treatment emergent Anti-MOR00208 antibody formation after combination therapy in immunogenicity analysis set (IAS)
    End point description
    Treatment emergent Anti-MOR00208 antibody formation after combination therapy in immunogenicity analysis set (IAS).
    End point type
    Secondary
    End point timeframe
    Cycle 1 to EOT (End of treatment).
    End point values
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Efficacy = MOR00208 + Venetoclax Immunogenicity Analysis Set
    Number of subjects analysed
    10
    13
    23
    Units: Number of subjects
    3
    0
    3
    No statistical analyses for this end point

    Secondary: Maximum plasma concentration (Cmax) of MOR00208 after combination therapy in pharmacokinetics analysis set (PKAS)

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    End point title
    		 Maximum plasma concentration (Cmax) of MOR00208 after combination therapy in pharmacokinetics analysis set (PKAS)
    End point description
    Maximum plasma concentration (Cmax) of MOR00208 after combination therapy in pharmacokinetics analysis set (PKAS).
    End point type
    Secondary
    End point timeframe
    At Cycle 3 Day 15.
    End point values
    		 Cohort A Safety and Efficacy = MOR00208 + Idelalisib Cohort B Efficacy = MOR00208 + Venetoclax PK Analysis Set
    Number of subjects analysed
    6
    7
    13
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    482148.3 ( 136938.69 )
    532045.7 ( 76098.68 )
    509016.2 ( 106673.52 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first administration of any study drug (MOR00208, Idelalisib or Venetoclax) to the patient until the 30-day safety follow-up visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Cohort A = MOR00208 + Idelalisib
    Reporting group description
    		 -

    Reporting group title
    Cohort B = MOR00208 + Venetoclax
    Reporting group description
    		 -

    Reporting group title
    Cohort B = MOR00208 Only
    Reporting group description
    		 No venetoclax was administered to these 2 patients as they had IRR to MOR00208 during the first infusion at C1D1 and study drug treatment was permanently discontinued.

    Serious adverse events
    		 Cohort A = MOR00208 + Idelalisib Cohort B = MOR00208 + Venetoclax Cohort B = MOR00208 Only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 11 (36.36%)
    3 / 11 (27.27%)
    2 / 2 (100.00%)
         number of deaths (all causes)
    2
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    2 / 2 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A = MOR00208 + Idelalisib Cohort B = MOR00208 + Venetoclax Cohort B = MOR00208 Only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 11 (100.00%)
    11 / 11 (100.00%)
    1 / 2 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Lung neoplasm
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Meningioma
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Aortic dilatation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Circulatory collapse
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Flushing
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hot flush
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Poor peripheral circulation
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular calcification
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 11 (18.18%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    3
    6
    0
    Pyrexia
         subjects affected / exposed
    5 / 11 (45.45%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    13
    2
    0
    Asthenia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Chills
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    General physical health deterioration
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Catheter site haematoma
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter site irritation
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Drug intolerance
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Face oedema
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling hot
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Gait disturbance
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Illness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Immunodeficiency
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Contrast media allergy
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Graft versus host disease in liver
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 11 (54.55%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    9
    6
    0
    Dyspnoea
         subjects affected / exposed
    6 / 11 (54.55%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    7
    3
    0
    Pleural effusion
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Atelectasis
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Haemothorax
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Increased bronchial secretion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary oedema
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Rales
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Small airways disease
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Tachypnoea
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumothorax
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    Agitation
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 11 (27.27%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    3
    4
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    4 / 11 (36.36%)
    0 / 2 (0.00%)
         occurrences all number
    0
    4
    0
    C-reactive protein increased
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Troponin T increased
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    Amylase increased
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    1
    Blood immunoglobulin G decreased
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Brain natriuretic peptide increased
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Coombs test positive
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Body temperature increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Digestive enzyme increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Lipase increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Prothrombin time prolonged
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Sapovirus test positive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Troponin increased
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Weight increased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    5 / 11 (45.45%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    5
    7
    0
    Arthropod bite
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Medication error
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Overdose
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Post vaccination syndrome
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Skin injury
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Tendon rupture
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    1
    Arrhythmia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Atrioventricular block
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Coronary artery disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    3
    6
    0
    Burning sensation
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Complex regional pain syndrome
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Lethargy
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    5 / 11 (45.45%)
    5 / 11 (45.45%)
    1 / 2 (50.00%)
         occurrences all number
    16
    26
    1
    Anaemia
         subjects affected / exposed
    6 / 11 (54.55%)
    4 / 11 (36.36%)
    0 / 2 (0.00%)
         occurrences all number
    7
    6
    0
    Leukopenia
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    1
    4
    0
    Thrombocytopenia
         subjects affected / exposed
    3 / 11 (27.27%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Lymphopenia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Anaemia of malignant disease
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Leukocytosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    Splenic infarction
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    Deafness
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Deafness unilateral
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Ear discomfort
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema of eyelid
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Holmes-Adie pupil
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Pupils unequal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 11 (45.45%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    7
    5
    0
    Nausea
         subjects affected / exposed
    2 / 11 (18.18%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    2
    8
    0
    Dyspepsia
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    Vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    1 / 2 (50.00%)
         occurrences all number
    0
    2
    1
    Abdominal pain
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Anal haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    Diverticulum
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Erosive duodenitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis erosive
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Glossitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Noninfective sialoadenitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Hydrocholecystis
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Hepatic cyst
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic lesion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatotoxicity
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Skin lesion
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    1
    5
    0
    Rash
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    Skin haemorrhage
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Alopecia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Eczema
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    5
    0
    Onychoclasis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Skin mass
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hydronephrosis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pyelocaliectasis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Renal impairment
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Urine flow decreased
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    4
    0
    Muscle spasms
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Pain in extremity
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Back pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Bone pain
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Exostosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Joint swelling
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle atrophy
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Myopathy
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Osteosclerosis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Spondylolisthesis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    2
    4
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 11 (36.36%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    7
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Sinusitis
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    2
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    0
    Bronchitis
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Infection
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Aspergillus infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Bacterial sepsis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Chronic sinusitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Escherichia infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal oesophagitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Helicobacter infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Influenza
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Liver abscess
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Norovirus infection
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    4 / 11 (36.36%)
    1 / 2 (50.00%)
         occurrences all number
    0
    5
    1
    Hypocalcaemia
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    2
    3
    0
    Hypokalaemia
         subjects affected / exposed
    2 / 11 (18.18%)
    2 / 11 (18.18%)
    1 / 2 (50.00%)
         occurrences all number
    2
    2
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 11 (0.00%)
    3 / 11 (27.27%)
    1 / 2 (50.00%)
         occurrences all number
    0
    3
    1
    Iron deficiency
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    2
    0
    1
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    1
    0
    1
    Decreased appetite
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Dehydration
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Folate deficiency
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    Hypermagnesaemia
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoproteinaemia
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported.
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    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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