Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants with Relapsed / Refractory Multiple Myeloma – dreaMM 6

    Summary
    EudraCT number
    		 2017-004689-93
    Trial protocol
    		 GB   ES  
    Global end of trial date
    29 Feb 2024

    Results information
    Results version number
    		 v3(current)
    This version publication date
    15 Mar 2025
    First version publication date
    15 Mar 2024
    Other versions
    		 v1 , v2
    Version creation reason
    • New data added to full data set
    EOS results
    Summary report(s)
    		 207497 LSLV update of results summary_27Feb2025

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    207497
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03544281
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.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
    Interim
    Date of interim/final analysis
    05 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Part 1 - To determine safety, tolerability, and to determine the RP2D dose of GSK2857916 administered in combination with either Len/Dex (Arm A) or Bor/Dex (Arm B) in subjects with RRMM. Part 2 - To assess the clinical activity after treatment with the RP2D of GSK2857916 administered in combination with Len/Dex (Treatment A) or Bor/Dex (Treatment B) in subjects with RRMM.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 79
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 29
    Country: Number of subjects enrolled
    United States: 29
    Country: Number of subjects enrolled
    Canada: 1
    Worldwide total number of subjects
    153
    EEA total number of subjects
    15
    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)
    59
    From 65 to 84 years
    94
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Arm description
    		 Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin intravenous (IV) solution as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with 25 mg or 10 mg Lenalidomide capsule orally on Days 1-21 of each 28 day cycle with 40 mg Dexamethasone tablet weekly per oral (PO)/ Dexamethasone Sodium Phosphate Injection (USP) as IV on Days 1, 8, 15, & 22 of each cycle

    Arm title
    		 Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Injection, Infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Arm title
    		 Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Arm title
    		 Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Arm title
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Arm title
    		 Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Arm description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use, Subcutaneous use
    Dosage and administration details
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Number of subjects in period 1 [1]
    		Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Started
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    DLT-evaluable
    0
    3
    4
    6
    0
    0
    0
    0
    0
    6
    0
    7
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
         Adverse event, serious fatal
    3
    2
    6
    8
    4
    2
    4
    5
    5
    8
    6
    4
         Consent withdrawn by subject
    2
    -
    1
    2
    -
    -
    -
    -
    2
    3
    -
    4
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
         Ongoing
    7
    2
    6
    6
    8
    10
    8
    6
    6
    6
    5
    8
         Investigator Site Closed
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Lost to follow-up
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Worldwide 153 participants were enrolled, whereof 152 participants were actually included in the study.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Reporting group description
    		 Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex Total
    Number of subjects
    		 12 4 13 16 12 12 12 12 13 18 12 16 152
    Age Categorical
    Units: Participants
        18 to <65 years
    		 4 3 4 4 6 3 4 4 5 6 6 9 58
        65 to <75 years
    		 5 1 8 8 3 8 7 4 5 8 5 5 67
        >=75 years
    		 3 0 1 4 3 1 1 4 3 4 1 2 27
    Sex: Female, Male
    Units: Participants
        Male
    		 10 4 8 13 7 9 7 5 11 11 8 11 104
        Female
    		 2 0 5 3 5 3 5 7 2 7 4 5 48
    Race/Ethnicity, Customized
    Units: Subjects
        African American/African Heritage
    		 0 0 0 1 0 0 1 3 0 4 0 1 10
        Asian - Central/South Asian Heritage
    		 0 0 0 1 0 0 0 0 0 1 0 0 2
        Asian - East Asian Heritage
    		 0 0 0 0 0 0 0 1 0 0 0 0 1
        Asian - South East Asian Heritage
    		 0 0 0 0 1 0 0 0 0 1 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 1 0 0 0 0 0 0 0 1 0 0 0 2
        White - Arabic/North African Heritage
    		 0 0 0 1 0 0 0 1 0 0 1 0 3
        White - White/Caucasian/European Heritage
    		 11 4 13 13 11 11 10 7 11 12 11 15 129
        Missing
    		 0 0 0 0 0 1 1 0 1 0 0 0 3

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Reporting group description
    		 Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Primary: Number of participants with dose limiting toxicities (DLTs), Treatment A - DLT-evaluable population

    		 Close Top of page
    End point title
    		 Number of participants with dose limiting toxicities (DLTs), Treatment A - DLT-evaluable population [1] [2]
    End point description
    DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to study therapy during the 28 day DLT period and meets at least one of the DLT criteria: Grade 3/greater febrile neutropenia lasting >48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia <25,000/mm^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist >48 h despite supportive treatment/abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment). DLT-evaluable population included participants who received at least 1 full dose of belantamab mafodotin and at least 75% of planned doses of Len/Dex by the end of Cycle 1 (Day 28).As per protocol only specified arms were planned to be analyzed.
    End point type
    Primary
    End point timeframe
    Up to 28 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    3
    4
    6
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with DLTs, Treatment B - DLT-evaluable population

    		 Close Top of page
    End point title
    		 Number of participants with DLTs, Treatment B - DLT-evaluable population [3] [4]
    End point description
    DLT is an adverse event (AE) that is considered by the investigator to be clinically relevant and attributed to study therapy during the 21 day DLT period and meets at least one of the DLT criteria: Grade 3/greater febrile neutropenia lasting >48 hours (h) despite adequate treatment; Grade 4 thrombocytopenia <25,000/mm^3 accompanied by significant bleeding; any Grade 3 or greater non-hematologic laboratory value (if laboratory abnormality persist >48 h despite supportive treatment/abnormality leading to hospitalisation); non-hematologic toxicity which does not resolve with appropriate supportive treatment within 48 h, Grade 4 corneal adverse events; and other organ specific toxicities (liver toxicity that causes discontinuation of treatment). DLT-evaluable population included participants who received at least 1 full dose of belantamab mafodotin and ≥75% of planned doses of Bor/Dex by the end of Cycle 1 (Day 21).As per protocol only specified arms were planned to be analyzed.
    End point type
    Primary
    End point timeframe
    Up to 21 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    6
    7
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Number of participants with adverse events (AEs) and serious adverse events (SAEs) - All treated population

    		 Close Top of page
    End point title
    		 Number of participants with adverse events (AEs) and serious adverse events (SAEs) - All treated population [5]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. All treated population included participants who took at least 1 dose of any study treatment. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
    End point type
    Primary
    End point timeframe
    Up to approximately 4.5 years
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Any AE
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
        Any SAE
    6
    2
    6
    10
    8
    8
    6
    6
    7
    13
    6
    9
    No statistical analyses for this end point

    Primary: Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) - All treated population

    		 Close Top of page
    End point title
    		 Number of participants with Worst-Case Amount of Increase from Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF) - All treated population [6]
    End point description
    12-lead electrocardiogram (ECGs) were obtained using an automated electrocardiogram (ECG) machine that automatically calculated the QTcF intervals. QTc values are categorized into the clinical concern ranges which are specific to changes in QTc: 31-60 milliseconds (msec), and >60 msec, and >530msec. An increase is defined relative to Baseline. Baseline (Day 1) was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data of number of participants with worst-case increase post baseline is presented.
    End point type
    Primary
    End point timeframe
    Up to approximately 4.5 years
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    10
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Increase of 31-60 msec
    3
    3
    5
    3
    1
    3
    1
    2
    5
    4
    5
    5
        Increase of >60 msec
    0
    0
    3
    2
    0
    0
    0
    0
    1
    2
    0
    0
        Increase of >530 msec
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters - All treated population [7]
    End point description
    Blood samples were collected for analysis of following hematology parameters: Hemoglobin (hemoglobin increased and anemia), Lymphocytes (lymphocyte count increased and lymphocyte count decreased), Neutrophils, Platelets and Leukocytes (leukocytosis and white blood cells decreased). The laboratory parameters were graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Hemoglobin increased, Any Grade Increase
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
        Hemoglobin increased, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hemoglobin increased, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Anemia, Any Grade Increase
    7
    2
    8
    9
    5
    6
    2
    3
    9
    11
    8
    10
        Anemia, Increase to Grade 3
    0
    0
    3
    2
    2
    2
    1
    2
    5
    2
    2
    3
        Anemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Lymphocyte count increased, Any Grade Increase
    0
    1
    0
    0
    2
    2
    0
    0
    0
    0
    0
    1
        Lymphocyte count increased, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Lymphocyte count increased, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Lymphocyte count decreased, Any Grade Increase
    11
    3
    10
    12
    11
    12
    10
    11
    12
    13
    10
    15
        Lymphocyte count decreased, Increase to Grade 3
    7
    1
    3
    4
    5
    6
    3
    5
    6
    6
    3
    8
        Lymphocyte count decreased, Increase to Grade 4
    0
    0
    1
    3
    1
    3
    2
    1
    3
    2
    3
    1
        Neutrophils, Any Grade Increase
    8
    3
    9
    9
    6
    6
    5
    4
    7
    10
    8
    9
        Neutrophils, Increase to Grade 3
    3
    2
    4
    4
    1
    3
    3
    1
    3
    1
    4
    2
        Neutrophils, Increase to Grade 4
    0
    0
    1
    1
    0
    1
    0
    0
    1
    3
    0
    0
        Platelets, Any Grade Increase
    9
    4
    12
    15
    11
    12
    11
    12
    13
    18
    12
    16
        Platelets, Increase to Grade 3
    1
    1
    4
    5
    3
    2
    4
    3
    5
    3
    2
    3
        Platelets, Increase to Grade 4
    1
    0
    2
    1
    7
    9
    5
    6
    6
    9
    9
    10
        Leukocytosis, Any Grade Increase
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Leukocytosis, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Leukocytosis, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        White blood cell decreased, Any Grade Increase
    10
    3
    11
    8
    5
    8
    3
    7
    8
    11
    8
    13
        White blood cell decreased, Increase to Grade 3
    2
    0
    1
    3
    1
    2
    1
    0
    2
    3
    3
    0
        White blood cell decreased, Increase to Grade 4
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worst-case Change Post-baseline in Hematology Parameters - All treated population [8]
    End point description
    Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, erythrocytes and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Basophils, Decrease to Low
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    2
        Basophils, Change to Normal or No Change
    10
    4
    10
    10
    9
    10
    10
    11
    11
    12
    11
    12
        Basophils, Increase to High
    2
    0
    3
    4
    2
    1
    2
    1
    2
    2
    1
    1
        Eosinophils, Decrease to Low
    2
    1
    4
    2
    1
    3
    0
    2
    3
    2
    1
    2
        Eosinophils, Change to Normal or No Change
    7
    2
    8
    7
    11
    9
    12
    10
    10
    11
    10
    13
        Eosinophils, Increase to High
    3
    2
    3
    6
    0
    0
    0
    1
    0
    3
    1
    0
        Hematocrit, Decrease to Low
    4
    1
    1
    4
    2
    5
    1
    1
    3
    3
    1
    7
        Hematocrit, Change to Normal or No Change
    8
    3
    12
    12
    10
    7
    9
    11
    10
    14
    11
    8
        Hematocrit, Increase to High
    1
    0
    0
    0
    0
    1
    2
    0
    0
    1
    0
    1
        MCH, Decrease to Low
    0
    0
    3
    1
    0
    3
    1
    3
    2
    6
    2
    1
        MCH, Change to Normal or No Change
    9
    3
    7
    13
    10
    7
    8
    9
    10
    9
    10
    11
        MCH, Increase to High
    3
    1
    3
    2
    2
    3
    3
    0
    1
    4
    0
    4
        MCHC, Decrease to Low
    4
    0
    4
    4
    2
    6
    5
    6
    6
    7
    5
    5
        MCHC, Change to Normal or No Change
    8
    3
    9
    12
    8
    6
    6
    6
    6
    10
    6
    11
        MCHC, Increase to High
    0
    1
    1
    0
    2
    1
    1
    0
    1
    2
    1
    0
        MCV, Decrease to Low
    0
    0
    4
    1
    0
    2
    1
    2
    0
    4
    0
    0
        MCV, Change to Normal or No Change
    10
    3
    7
    11
    10
    7
    7
    10
    11
    10
    10
    13
        MCV, Increase to High
    2
    1
    3
    4
    2
    3
    5
    1
    2
    4
    2
    3
        Monocytes, Decrease to Low
    5
    1
    4
    3
    5
    4
    7
    8
    5
    7
    3
    5
        Monocytes, Change to Normal or No Change
    4
    2
    2
    4
    3
    1
    1
    1
    2
    3
    5
    4
        Monocytes, Increase to High
    4
    2
    11
    10
    6
    10
    10
    8
    8
    10
    5
    8
        Erythrocytes, Decrease to Low
    2
    1
    0
    1
    0
    2
    0
    0
    0
    4
    2
    3
        Erythrocytes, Change to Normal or No Change
    9
    3
    13
    13
    11
    10
    12
    11
    13
    14
    9
    13
        Erythrocytes, Increase to High
    1
    0
    0
    2
    1
    1
    0
    1
    0
    0
    1
    0
        Reticulocytes, Decrease to Low
    3
    1
    2
    4
    1
    1
    2
    4
    2
    4
    3
    5
        Reticulocytes, Change to Normal or No Change
    7
    1
    5
    7
    9
    6
    5
    2
    8
    6
    4
    2
        Reticulocytes, Increase to High
    3
    2
    7
    6
    2
    6
    7
    8
    3
    9
    6
    10
    No statistical analyses for this end point

    Primary: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters - All treated population [9]
    End point description
    Blood samples were collected for analysis of following clinical chemistry parameters: Hyperglycemia, Hypoglycemia, Albumin, Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase, (AST), Bilirubin, Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Hyperkalemia, Hypokalemia, Hypermagnesemia, Hypomagnesemia, Phosphate, Hypernatremia, Hyponatremia, Urate, Hypercalcemia and Hypocalcemia. Laboratory parameters were graded according to CTCAE v4.03. Grade (G) 1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Hyperglycemia, Any Grade Increase
    3
    1
    9
    11
    8
    9
    9
    8
    5
    10
    6
    8
        Hyperglycemia, Increase to Grade 3
    0
    0
    0
    1
    0
    0
    3
    1
    1
    1
    0
    1
        Hyperglycemia, Increase to Grade 4
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
        Hypoglycemia, Any Grade Increase
    2
    0
    1
    1
    0
    2
    1
    3
    0
    1
    0
    1
        Hypoglycemia, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Hypoglycemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Albumin, Any Grade Increase
    6
    2
    8
    9
    5
    8
    4
    5
    7
    14
    5
    8
        Albumin, Increase to Grade 3
    0
    0
    0
    0
    0
    2
    0
    2
    2
    0
    0
    0
        Albumin, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Alkaline Phosphatase, Any Grade Increase
    4
    0
    7
    6
    6
    4
    5
    6
    8
    8
    2
    5
        Alkaline Phosphatase, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Alkaline Phosphatase, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT, Any Grade Increase
    7
    1
    7
    7
    5
    5
    9
    8
    6
    6
    7
    8
        ALT, Increase to Grade 3
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    0
    1
        ALT, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
        AST, Any Grade Increase
    4
    2
    8
    6
    10
    12
    8
    10
    8
    11
    8
    12
        AST, Increase to Grade 3
    0
    0
    0
    0
    0
    1
    1
    3
    1
    0
    0
    0
        AST, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
        Bilirubin, Any Grade Increase
    1
    0
    1
    4
    2
    2
    0
    3
    2
    2
    1
    5
        Bilirubin, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
        Bilirubin, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        CK, Any Grade Increase
    3
    2
    4
    2
    1
    3
    3
    4
    4
    4
    4
    7
        CK, Increase to Grade 3
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
        CK, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Creatinine, Any Grade Increase
    1
    0
    7
    2
    2
    2
    6
    2
    4
    3
    1
    6
        Creatinine, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Creatinine, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        GGT, Any Grade Increase
    9
    1
    9
    9
    6
    7
    5
    10
    8
    10
    6
    9
        GGT, Increase to Grade 3
    2
    0
    2
    4
    1
    2
    1
    2
    1
    2
    0
    2
        GGT, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        Hyperkalemia, Any Grade Increase
    0
    0
    1
    1
    0
    2
    0
    0
    3
    3
    0
    3
        Hyperkalemia, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hyperkalemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hypokalemia, Any Grade Increase
    3
    2
    3
    4
    6
    4
    8
    3
    4
    6
    7
    4
        Hypokalemia, Increase to Grade 3
    1
    0
    2
    2
    0
    1
    0
    0
    0
    0
    0
    1
        Hypokalemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hypermagnesemia, Any Grade Increase
    0
    0
    1
    0
    2
    0
    1
    0
    4
    1
    1
    2
        Hypermagnesemia, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
        Hypermagnesemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hypomagnesemia, Any Grade Increase
    3
    2
    3
    4
    3
    2
    0
    1
    1
    7
    4
    4
        Hypomagnesemia, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hypomagnesemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Phosphate, Any Grade Increase
    6
    3
    5
    4
    4
    7
    6
    5
    8
    8
    8
    7
        Phosphate, Increase to Grade 3
    2
    1
    3
    1
    0
    2
    2
    2
    3
    3
    3
    0
        Phosphate, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hypernatremia, Any Grade Increase
    1
    0
    1
    1
    1
    2
    4
    2
    1
    1
    1
    2
        Hypernatremia, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hypernatremia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hyponatremia, Any Grade Increase
    4
    1
    3
    3
    4
    3
    3
    5
    4
    4
    2
    5
        Hyponatremia, Increase to Grade 3
    0
    1
    0
    2
    1
    0
    0
    2
    1
    1
    0
    1
        Hyponatremia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urate, Any Grade Increase
    1
    0
    1
    1
    1
    1
    0
    1
    0
    0
    0
    1
        Urate, Increase to Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urate, Increase to Grade 4
    1
    0
    1
    1
    1
    1
    0
    1
    0
    0
    0
    1
        Hypercalcemia, Any Grade Increase
    0
    0
    2
    1
    2
    2
    2
    1
    3
    4
    1
    1
        Hypercalcemia, Increase to Grade 3
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
        Hypercalcemia, Increase to Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
        Hypocalcemia, Any Grade Increase
    5
    0
    4
    2
    1
    3
    2
    2
    5
    1
    0
    3
        Hypocalcemia, Increase to Grade 3
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
        Hypocalcemia, Increase to Grade 4
    3
    0
    2
    1
    0
    1
    0
    1
    2
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters - All treated population [10]
    End point description
    Blood samples were collected for analysis of following clinical chemistry parameters: Direct Bilirubin (DB), Calcium, Chloride, Carbon Dioxide (CO2), lactate dehydrogenase (LDH) and Protein. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values from baseline have been presented. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        DB, Decrease to Low
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        DB, Change to Normal or No Change
    4
    4
    9
    8
    11
    8
    10
    9
    9
    13
    10
    14
        DB, Increase to High
    6
    0
    4
    5
    1
    4
    2
    2
    3
    5
    2
    2
        Calcium, Decrease to Low
    7
    1
    7
    7
    2
    6
    4
    2
    5
    9
    2
    5
        Calcium, Change to Normal or No Change
    5
    3
    6
    7
    8
    5
    6
    10
    8
    8
    6
    11
        Calcium, Increase to High
    0
    0
    1
    1
    2
    1
    2
    0
    1
    2
    4
    1
        Chloride, Decrease to Low
    1
    1
    1
    3
    0
    0
    1
    1
    3
    3
    1
    2
        Chloride, Change to Normal or No Change
    5
    3
    8
    10
    8
    7
    5
    10
    7
    9
    10
    12
        Chloride, Increase to High
    5
    0
    4
    2
    4
    5
    6
    1
    4
    6
    1
    2
        CO2, Decrease to Low
    5
    0
    5
    5
    5
    3
    3
    1
    5
    4
    4
    2
        CO2, Change to Normal or No Change
    7
    4
    7
    7
    5
    7
    9
    8
    6
    14
    8
    11
        CO2, Increase to High
    0
    0
    1
    2
    1
    2
    0
    3
    2
    1
    0
    3
        Protein, Decrease to Low
    8
    2
    5
    12
    3
    7
    7
    6
    7
    11
    7
    10
        Protein, Change to Normal or No Change
    4
    2
    8
    3
    8
    5
    4
    5
    5
    5
    4
    5
        Protein, Increase to High
    0
    0
    0
    1
    1
    0
    1
    1
    1
    2
    1
    1
        LDH, Decrease to Low
    0
    0
    2
    2
    0
    0
    0
    1
    1
    0
    2
    0
        LDH, Change to Normal or No Change
    5
    1
    3
    6
    4
    4
    3
    4
    4
    1
    4
    5
        LDH, Increase to High
    6
    3
    9
    8
    8
    8
    9
    7
    8
    17
    8
    11
    No statistical analyses for this end point

    Primary: Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein - All treated population

    		 Close Top of page
    End point title
    		 Number of participants with Worst-case change post baseline urinalysis results: Occult Blood and Protein - All treated population [11]
    End point description
    Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased and increase to trace, 1+, 2+, 3+, >3+ indicating proportional concentrations in the urine sample. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    4
    13
    13
    9
    12
    12
    12
    12
    18
    11
    16
    Units: Participants
        Occult Blood, No Change/Decreased
    5
    2
    6
    6
    6
    8
    6
    9
    4
    11
    7
    12
        Occult Blood, Increase to TRACE
    1
    2
    3
    4
    0
    2
    2
    1
    5
    1
    0
    0
        Occult Blood, Increase to 1+
    1
    0
    1
    0
    2
    0
    1
    1
    1
    4
    2
    3
        Occult Blood, Increase to 2+
    3
    0
    2
    2
    1
    1
    2
    1
    1
    1
    2
    1
        Occult Blood, Increase to 3+
    0
    0
    0
    1
    0
    1
    1
    0
    0
    1
    0
    0
        Occult Blood, Increase to >3+
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Protein, No Change/Decreased
    5
    2
    7
    3
    2
    5
    5
    6
    5
    8
    4
    5
        Protein, Increase to TRACE
    2
    0
    1
    6
    1
    2
    2
    2
    1
    2
    0
    1
        Protein, Increase to 1+
    1
    0
    3
    0
    2
    2
    4
    2
    2
    4
    2
    6
        Protein, Increase to 2+
    2
    0
    2
    3
    2
    0
    1
    2
    2
    2
    2
    3
        Protein, Increase to 3+
    0
    2
    0
    1
    1
    3
    0
    0
    2
    2
    3
    1
        Protein, Increase to >3+
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Change from baseline in urine Potential of Hydrogen (pH) - All treated population

    		 Close Top of page
    End point title
    		 Change from baseline in urine Potential of Hydrogen (pH) - All treated population [12]
    End point description
    Urine samples were collected to analyze urine pH levels. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    4
    13
    12
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Potential of Hydrogen (pH)
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    5.9 ( 0.46 )
    5.8 ( 0.65 )
    6.0 ( 0.90 )
    5.8 ( 0.69 )
    6.1 ( 0.68 )
    5.8 ( 0.62 )
    6.4 ( 0.87 )
    5.6 ( 0.48 )
    5.9 ( 0.82 )
    6.1 ( 0.82 )
    5.9 ( 1.18 )
    5.7 ( 0.70 )
        End of Treatment
    0.1 ( 1.08 )
    -0.2 ( 0.76 )
    0.4 ( 1.38 )
    0.2 ( 0.29 )
    -0.3 ( 0.61 )
    0.6 ( 0.42 )
    -0.5 ( 0.50 )
    0.2 ( 0.66 )
    0.4 ( 1.03 )
    0.2 ( 0.80 )
    0.4 ( 0.55 )
    0.2 ( 1.05 )
    No statistical analyses for this end point

    Primary: Change from baseline in urine specific gravity - All treated population

    		 Close Top of page
    End point title
    		 Change from baseline in urine specific gravity - All treated population [13]
    End point description
    Urine samples were collected to analyze urine specific gravity using dipstick method. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    7
    4
    13
    11
    6
    12
    9
    11
    12
    18
    11
    14
    Units: Ratio
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    1.0217 ( 0.00687 )
    1.0253 ( 0.00660 )
    1.0169 ( 0.00946 )
    1.0175 ( 0.00682 )
    1.0217 ( 0.00931 )
    1.0175 ( 0.00544 )
    1.0133 ( 0.00661 )
    1.0167 ( 0.00736 )
    1.0193 ( 0.00612 )
    1.0152 ( 0.00817 )
    1.0174 ( 0.00713 )
    1.0139 ( 0.00627 )
        End of Treatment
    0.0003 ( 0.00058 )
    -0.0090 ( 0.01217 )
    -0.0013 ( 0.01072 )
    0.0023 ( 0.00643 )
    0.0075 ( 0.00354 )
    -0.0020 ( 0.00671 )
    0.0050 ( 0.00707 )
    0.0029 ( 0.01029 )
    -0.0010 ( 0.00529 )
    0.0005 ( 0.00782 )
    -0.0026 ( 0.00792 )
    0.0067 ( 0.00830 )
    No statistical analyses for this end point

    Primary: Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP) - All treated population

    		 Close Top of page
    End point title
    		 Change from Baseline in vital Signs: Diastolic blood pressure (DBP) and Systolic blood pressure (SBP) - All treated population [14]
    End point description
    Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. 99999 = Data cannot be evaluated for single participant. 88888 = Data was not collected for particular timepoint. Only those participants with data available at specified time points have been analyzed.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1, predose) and up to approximately 4.5 years
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    17
    12
    16
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        DBP, BASELINE (Day 1)
    72.3 ( 7.67 )
    86.0 ( 12.49 )
    79.5 ( 9.36 )
    71.4 ( 12.04 )
    73.6 ( 17.15 )
    75.1 ( 9.08 )
    78.4 ( 11.13 )
    76.1 ( 7.14 )
    72.2 ( 8.52 )
    74.9 ( 8.77 )
    72.9 ( 11.85 )
    77.8 ( 10.61 )
        DBP, WEEK 79 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    19.0 ( 99999 )
    2.0 ( 99999 )
    -1.0 ( 99999 )
    -23.0 ( 99999 )
        DBP, WEEK 79 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -8.0 ( 99999 )
    -3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    12.0 ( 99999 )
    -2.0 ( 99999 )
    -11.0 ( 99999 )
    -14.0 ( 99999 )
        DBP, WEEK 79 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    -6.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    19.0 ( 99999 )
    5.0 ( 99999 )
    -10.0 ( 99999 )
    -44.0 ( 99999 )
        DBP, WEEK 91 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    6.0 ( 99999 )
    88888 ( 88888 )
    4.0 ( 99999 )
    -4.0 ( 99999 )
    -26.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 91 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.0 ( 0.0 )
    88888 ( 88888 )
    10.0 ( 99999 )
    1.0 ( 99999 )
    -15.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 91 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    10.0 ( 99999 )
    88888 ( 88888 )
    3.0 ( 99999 )
    -2.0 ( 99999 )
    -16.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 94 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -24.0 ( 99999 )
    88888 ( 88888 )
    4.0 ( 99999 )
    -7.0 ( 99999 )
    -2.0 ( 99999 )
    88888 ( 88888 )
        DBP, WEEK 94 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -21.0 ( 99999 )
    88888 ( 88888 )
    6.0 ( 99999 )
    4.0 ( 99999 )
    3.0 ( 99999 )
    88888 ( 88888 )
        DBP, WEEK 94 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -21.0 ( 99999 )
    88888 ( 88888 )
    14.0 ( 99999 )
    -5.0 ( 99999 )
    2.0 ( 99999 )
    88888 ( 88888 )
        DBP, WEEK 109 DAY 1, Predose
    5.0 ( 99999 )
    88888 ( 88888 )
    2.0 ( 99999 )
    -1.7 ( 2.08 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -4.5 ( 0.71 )
    6.0 ( 99999 )
    88888 ( 88888 )
    -14.0 ( 99999 )
        DBP, WEEK 109 DAY 1, 0.25hour Post-Dose
    -4.0 ( 99999 )
    88888 ( 88888 )
    -2.0 ( 99999 )
    0.0 ( 6.24 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    1.5 ( 7.78 )
    6.0 ( 99999 )
    88888 ( 88888 )
    -21.0 ( 99999 )
        DBP, WEEK 109 DAY 1, 1hour Post-Dose
    9.0 ( 99999 )
    88888 ( 88888 )
    2.0 ( 99999 )
    0.0 ( 5.57 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    5.5 ( 2.12 )
    3.0 ( 99999 )
    88888 ( 88888 )
    -27.0 ( 99999 )
        DBP, WEEK 133 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -2.0 ( 2.83 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    6.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -16.0 ( 99999 )
        DBP, WEEK 133 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    1.0 ( 7.07 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -18.0 ( 99999 )
        DBP, WEEK 133 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    4.5 ( 3.54 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    8.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -14.0 ( 99999 )
        DBP, WEEK 153 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    5.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 153 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    10.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 153 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    4.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 169 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    11.0 ( 99999 )
    -16.5 ( 26.16 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 169 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    6.0 ( 99999 )
    3.0 ( 4.24 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 169 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    7.0 ( 99999 )
    -11.0 ( 16.97 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 169 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    11.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 169 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    6.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 169 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 173 DAY 1, Predose
    88888 ( 88888 )
    -14.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 173 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    -10.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 173 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    -3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 221 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -2.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 221 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -10.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        DBP, WEEK 221 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    2.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, BASELINE (Day 1)
    127.8 ( 18.62 )
    137.5 ( 7.05 )
    136.1 ( 26.03 )
    125.3 ( 15.71 )
    136.4 ( 18.99 )
    129.7 ( 15.13 )
    132.8 ( 17.88 )
    135.4 ( 16.68 )
    122.3 ( 13.94 )
    143.3 ( 25.93 )
    126.8 ( 21.48 )
    138.5 ( 21.29 )
        SBP, WEEK 79 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    11.0 ( 99999 )
    5.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    8.0 ( 99999 )
    16.0 ( 99999 )
    -17.0 ( 99999 )
    -21.0 ( 99999 )
        SBP, WEEK 79 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    10.0 ( 99999 )
    -3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    8.0 ( 99999 )
    9.0 ( 99999 )
    -36.0 ( 99999 )
    -7.0 ( 99999 )
        SBP, WEEK 79 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    12.0 ( 99999 )
    -2.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -1.0 ( 99999 )
    0.0 ( 0.0 )
    -41.0 ( 99999 )
    -1.0 ( 99999 )
        SBP, WEEK 91 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    88888 ( 88888 )
    -2.0 ( 99999 )
    4.0 ( 99999 )
    -22.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 91 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -15.0 ( 99999 )
    88888 ( 88888 )
    17.0 ( 99999 )
    12.0 ( 99999 )
    -31.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 91 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    21.0 ( 99999 )
    88888 ( 88888 )
    16.0 ( 99999 )
    4.0 ( 99999 )
    -15.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 94 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -28.0 ( 99999 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    -38.0 ( 99999 )
    12.0 ( 99999 )
    88888 ( 88888 )
        SBP, WEEK 94 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -30.0 ( 99999 )
    88888 ( 88888 )
    -4.0 ( 99999 )
    -23.0 ( 99999 )
    3.0 ( 99999 )
    88888 ( 88888 )
        SBP, WEEK 94 DAY 1, 1hour Post-Dose
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -35.0 ( 99999 )
    99999 ( 99999 )
    -4.0 ( 99999 )
    -32.0 ( 99999 )
    -5.0 ( 99999 )
    99999 ( 99999 )
        SBP, WEEK 109 DAY 1, Predose
    9.0 ( 99999 )
    88888 ( 88888 )
    -1.0 ( 99999 )
    -4.7 ( 16.01 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -1.0 ( 5.66 )
    -11.0 ( 99999 )
    88888 ( 88888 )
    -22.0 ( 99999 )
        SBP, WEEK 109 DAY 1, 0.25hour Post-Dose
    3.0 ( 99999 )
    99999 ( 99999 )
    1.0 ( 99999 )
    1.3 ( 15.89 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    -7.5 ( 0.71 )
    0.0 ( 0.0 )
    99999 ( 88888 )
    -23.0 ( 99999 )
        SBP, WEEK 109 DAY 1, 1hour Post-Dose
    3.0 ( 99999 )
    88888 ( 88888 )
    -3.0 ( 99999 )
    7.3 ( 16.56 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -1.5 ( 4.95 )
    8.0 ( 99999 )
    88888 ( 88888 )
    -31.0 ( 99999 )
        SBP, WEEK 133 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -9.0 ( 1.41 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    4.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -16.0 ( 99999 )
        SBP, WEEK 133 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    3.0 ( 9.90 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -2.0 ( 99999 )
        SBP, WEEK 133 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    5.0 ( 19.80 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -1.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -1.0 ( 99999 )
        SBP, WEEK 153 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    -3.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 153 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    13.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 153 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    7.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 169 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    -16.5 ( 28.99 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 169 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    -9.5 ( 7.78 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 169 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -1.0 ( 99999 )
    -6.5 ( 9.19 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 169 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    10.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 169 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    11.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 169 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    17.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 173 DAY 1, Predose
    88888 ( 88888 )
    -7.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 173 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    -7.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 173 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    -5.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 221 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    18.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 221 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    15.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SBP, WEEK 221 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    32.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Primary: Change from Baseline in vital Signs : Pulse Rate - All treated population

    		 Close Top of page
    End point title
    		 Change from Baseline in vital Signs : Pulse Rate - All treated population [15]
    End point description
    Pulse rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. 99999 = Data cannot be evaluated for single participant. 88888 = Data was not collected for particular timepoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1, pre-dose) and up to approximately 4.5 years
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    17
    12
    16
    Units: beats per minute
    arithmetic mean (standard deviation)
        BASELINE (Day 1)
    72.8 ( 9.01 )
    73.8 ( 11.90 )
    76.0 ( 17.10 )
    72.8 ( 14.65 )
    73.7 ( 13.05 )
    76.2 ( 12.69 )
    75.5 ( 11.21 )
    79.6 ( 13.36 )
    73.3 ( 14.31 )
    74.1 ( 10.76 )
    81.0 ( 10.05 )
    75.3 ( 10.82 )
        WEEK 79 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -9.0 ( 99999 )
    -18.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -14.0 ( 99999 )
    9.0 ( 99999 )
    1.0 ( 99999 )
    4.0 ( 99999 )
        WEEK 79 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -6.0 ( 99999 )
    -6.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    6.0 ( 99999 )
    -2.0 ( 99999 )
    2.0 ( 99999 )
    -9.0 ( 99999 )
        WEEK 79 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -18.0 ( 99999 )
    6.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    13.0 ( 99999 )
    -2.0 ( 99999 )
    4.0 ( 99999 )
    -6.0 ( 99999 )
        WEEK 91 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    1.0 ( 99999 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    24.0 ( 99999 )
    -5.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 91 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -2.0 ( 99999 )
    88888 ( 88888 )
    -19.0 ( 99999 )
    12.0 ( 99999 )
    -9.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 91 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -6.0 ( 99999 )
    88888 ( 88888 )
    -11.0 ( 99999 )
    11.0 ( 99999 )
    -19.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 94 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
    88888 ( 88888 )
    -14.0 ( 99999 )
    21.0 ( 99999 )
    13.0 ( 99999 )
    88888 ( 88888 )
        WEEK 94 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -4.0 ( 99999 )
    88888 ( 88888 )
    -22.0 ( 99999 )
    16.0 ( 99999 )
    12.0 ( 99999 )
    88888 ( 88888 )
        WEEK 94 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -4.0 ( 99999 )
    88888 ( 88888 )
    -28.0 ( 99999 )
    11.0 ( 99999 )
    14.0 ( 99999 )
    88888 ( 88888 )
        WEEK 109 DAY 1, Predose
    -19.0 ( 99999 )
    88888 ( 88888 )
    -22.0 ( 99999 )
    8.3 ( 5.13 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -6.0 ( 8.49 )
    -12.0 ( 99999 )
    88888 ( 88888 )
    -9.0 ( 99999 )
        WEEK 109 DAY 1, 0.25hour Post-Dose
    -18.0 ( 99999 )
    88888 ( 88888 )
    -24.0 ( 99999 )
    0.3 ( 3.06 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    10.5 ( 41.72 )
    -16.0 ( 99999 )
    88888 ( 88888 )
    -8.0 ( 99999 )
        WEEK 109 DAY 1, 1hour Post-Dose
    -4.0 ( 99999 )
    88888 ( 88888 )
    -25.0 ( 99999 )
    1.3 ( 5.69 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -8.0 ( 11.31 )
    -12.0 ( 99999 )
    88888 ( 88888 )
    0.0 ( 0.0 )
        WEEK 133 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    6.5 ( 9.19 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -11.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
        WEEK 133 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    4.5 ( 0.71 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -12.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -5.0 ( 99999 )
        WEEK 133 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    5.5 ( 2.12 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -16.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -17.0 ( 99999 )
        WEEK 153 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    -8.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 153 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    -10.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 153 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    -9.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -15.0 ( 99999 )
    -21.0 ( 5.66 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -23.0 ( 99999 )
    -19.0 ( 2.83 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -20.0 ( 99999 )
    -21.0 ( 1.41 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -21.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -17.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -20.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 173 DAY 1, Predose
    88888 ( 88888 )
    -7.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 173 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    -5.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 173 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    -8.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 221 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -4.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 221 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    2.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 221 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    8.0 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Primary: Change from Baseline in vital Signs : Temperature - All treated population

    		 Close Top of page
    End point title
    		 Change from Baseline in vital Signs : Temperature - All treated population [16]
    End point description
    Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated as post-dose visit value minus Baseline value. 99999 = Data cannot be evaluated for single participant. 88888 = Data was not collected for particular timepoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1, pre-dose) and up to approximately 4.5 years
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    17
    12
    16
    Units: Degree Celsius (C)
    arithmetic mean (standard deviation)
        BASELINE (Day 1)
    36.61 ( 0.417 )
    36.70 ( 0.346 )
    36.46 ( 0.307 )
    36.43 ( 0.334 )
    36.46 ( 0.348 )
    36.44 ( 0.291 )
    36.52 ( 0.432 )
    36.68 ( 0.305 )
    36.53 ( 0.338 )
    36.48 ( 0.571 )
    36.51 ( 0.581 )
    36.58 ( 0.397 )
        WEEK 79 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.30 ( 99999 )
    0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.70 ( 99999 )
    -0.10 ( 99999 )
    1.30 ( 99999 )
    0.00 ( 0.00 )
        WEEK 79 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.30 ( 99999 )
    0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.20 ( 99999 )
    -0.10 ( 99999 )
    1.60 ( 99999 )
    0.00 ( 0.00 )
        WEEK 79 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.10 ( 99999 )
    0.40 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.50 ( 99999 )
    0.00 ( 0.00 )
    1.40 ( 99999 )
    0.00 ( 0.00 )
        WEEK 91 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.40 ( 99999 )
    88888 ( 88888 )
    -0.60 ( 99999 )
    0.50 ( 99999 )
    -0.70 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 91 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.40 ( 99999 )
    88888 ( 88888 )
    -0.80 ( 99999 )
    0.10 ( 99999 )
    0.20 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 91 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.50 ( 99999 )
    88888 ( 88888 )
    -0.50 ( 99999 )
    0.50 ( 99999 )
    0.30 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 94 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.20 ( 99999 )
    88888 ( 88888 )
    0.10 ( 99999 )
    -0.30 ( 99999 )
    0.30 ( 99999 )
    88888 ( 88888 )
        WEEK 94 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.30 ( 99999 )
    88888 ( 88888 )
    0.30 ( 99999 )
    0.10 ( 99999 )
    0.30 ( 99999 )
    88888 ( 88888 )
        WEEK 94 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.40 ( 99999 )
    88888 ( 88888 )
    0.00 ( 0.00 )
    0.10 ( 99999 )
    0.30 ( 99999 )
    88888 ( 88888 )
        WEEK 109 DAY 1, Predose
    -0.90 ( 99999 )
    88888 ( 88888 )
    -0.80 ( 99999 )
    0.20 ( 0.173 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.20 ( 0.283 )
    -0.20 ( 99999 )
    88888 ( 88888 )
    0.40 ( 99999 )
        WEEK 109 DAY 1, 0.25hour Post-Dose
    -1.20 ( 99999 )
    88888 ( 88888 )
    -0.80 ( 99999 )
    0.07 ( 0.153 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.15 ( 0.071 )
    0.20 ( 99999 )
    88888 ( 88888 )
    0.40 ( 99999 )
        WEEK 109 DAY 1, 1hour Post-Dose
    -1.20 ( 99999 )
    88888 ( 88888 )
    -0.50 ( 99999 )
    0.10 ( 0.173 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.15 ( 0.071 )
    0.10 ( 99999 )
    88888 ( 88888 )
    0.40 ( 99999 )
        WEEK 133 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.60 ( 0.283 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.40 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    1.00 ( 99999 )
        WEEK 133 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.25 ( 0.071 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.30 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.70 ( 99999 )
        WEEK 133 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.45 ( 0.071 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.20 ( 99999 )
        WEEK 153 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    0.20 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 153 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    -0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 153 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    0.00 ( 0.00 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.20 ( 99999 )
    0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.10 ( 99999 )
    0.05 ( 0.636 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.10 ( 99999 )
    -0.05 ( 0.071 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 8, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.20 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 8, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.40 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 169 DAY 8, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.30 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 173 DAY 1, Predose
    88888 ( 88888 )
    -0.30 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 173 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    -0.40 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 173 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    -0.40 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 221 DAY 1, Predose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 221 DAY 1, 0.25hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.10 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        WEEK 221 DAY 1, 1hour Post-Dose
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    -0.20 ( 99999 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Primary: Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM) - All treated population

    		 Close Top of page
    End point title
    		 Overall Response Rate (ORR) as defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM) - All treated population [17]
    End point description
    ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above plus normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR >= 90% reduction in serum M-component plus urine M-component <100 mg/24 h; PR = >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 h. Confidence intervals were based on the exact method.
    End point type
    Primary
    End point timeframe
    Up to approximately 4.5 years
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was descriptive; hence no statistical analysis to report.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Percentage of Participants
        number (confidence interval 95%)
    58 (27.7 to 84.8)
    75 (19.4 to 99.4)
    69 (38.6 to 90.9)
    69 (41.3 to 89.0)
    50 (21.1 to 78.9)
    83 (51.6 to 97.9)
    92 (61.5 to 99.8)
    75 (42.8 to 94.5)
    62 (31.6 to 86.1)
    78 (52.4 to 93.6)
    50 (21.1 to 78.9)
    69 (41.3 to 89.0)
    No statistical analyses for this end point

    Secondary: Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A - Pharmacokinetic (PK) population

    		 Close Top of page
    End point title
    		 Maximum observed concentration (Cmax) for belantamab mafodotin antibody-drug conjugate (ADC), Treatment A - Pharmacokinetic (PK) population [18]
    End point description
    Blood samples were collected at indicated timepoints for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods. Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. 88888 = Data was not collected for particular timepoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Pre-Dose, 0, 2 and 24 hours post-dose on Days 1 and 8
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    16
    Units: Microgram/ millilitre (ug/mL)
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    43.58 ( 21.78 )
    36.41 ( 17.06 )
    25.22 ( 16.53 )
    39.99 ( 25.03 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    27.60 ( 16.27 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A - PK population

    		 Close Top of page
    End point title
    		 Area under the concentration time curve (AUC) from time 0 to 504 hours (0-504h) for belantamab mafodotin ADC, Treatment A - PK population [19]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    3
    9
    9
    Units: Hour*microgram/millilitre (h*ug/mL)
        geometric mean (geometric coefficient of variation)
    3848.41 ( 24.25 )
    4802.83 ( 34.51 )
    4365.82 ( 10.25 )
    4127.66 ( 17.98 )
    No statistical analyses for this end point

    Secondary: AUC (0-672h) for belantamab mafodotin ADC, Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-672h) for belantamab mafodotin ADC, Treatment A - PK population [20]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    3
    9
    9
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    4093.12 ( 24.45 )
    5114.28 ( 34.72 )
    4699.00 ( 11.10 )
    4432.11 ( 17.65 )
    No statistical analyses for this end point

    Secondary: Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A - PK population

    		 Close Top of page
    End point title
    		 Time to reach maximum observed concentration (Tmax) for belantamab mafodotin ADC, Treatment A - PK population [21]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected for particular timepoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    15
    Units: Hour
    median (full range (min-max))
        CYCLE 1 DAY 1
    2.050 (0.57 to 2.37)
    1.342 (0.50 to 2.17)
    1.100 (0.57 to 2.20)
    2.000 (0.53 to 2.42)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    1.108 (0.57 to 23.93)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A - PK population

    		 Close Top of page
    End point title
    		 Trough concentration prior to the next dose for each cycle (Ctrough) for belantamab mafodotin ADC, Treatment A - PK population [22]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    16
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    88888 (88888 to 88888)
    1.79 (0.7 to 1.8)
    3.52 (2.5 to 4.7)
    1.08 (0.7 to 1.5)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    1.30 (0.7 to 2.4)
    88888 (88888 to 88888)
        WEEK 5 DAY 1
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    5.05 (2.4 to 7.0)
    77777 (77777 to 77777)
        WEEK 5 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    1.17 (0.1 to 3.6)
    88888 (88888 to 88888)
        WEEK 9 DAY 1
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    4.89 (3.0 to 8.4)
    77777 (77777 to 77777)
        WEEK 9 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    2.03 (1.8 to 3.9)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A - PK population

    		 Close Top of page
    End point title
    		 Time of last observed quantifiable concentration (tlast) for belantamab mafodotin ADC, Treatment A - PK population [23]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    16
    Units: Hour
        median (full range (min-max))
    181.467 (25.50 to 698.22)
    685.608 (191.58 to 697.75)
    674.833 (94.40 to 1273.75)
    671.717 (2.00 to 1342.83)
    No statistical analyses for this end point

    Secondary: Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A - PK population

    		 Close Top of page
    End point title
    		 Observed plasma concentration at the end of infusion (C-EOI) for belantamab mafodotin ADC, Treatment A - PK population [24]
    End point description
    Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Cycle 1: Pre-Dose, 0, 2 and 24 Hours Post-Dose on Days 1 and Day 8; Weeks 5, 9, and 13: Pre-Dose and Post-Dose on Days 1 and 8
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    11
    4
    12
    15
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    39.10 (27.2 to 49.5)
    36.05 (29.6 to 44.5)
    25.05 (18.2 to 31.5)
    41.80 (14.0 to 51.3)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    26.55 (18.6 to 35.2)
    88888 (88888 to 88888)
        WEEK 5 DAY 1
    88888 (88888 to 88888)
    35.45 (33.8 to 42.0)
    23.00 (20.5 to 27.2)
    36.75 (25.6 to 96.2)
        WEEK 5 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    27.10 (23.6 to 41.8)
    88888 (88888 to 88888)
        WEEK 9 DAY 1
    42.35 (31.1 to 49.5)
    77777 (77777 to 77777)
    23.50 (15.3 to 31.8)
    77777 (77777 to 77777)
        WEEK 9 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    25.60 (17.1 to 31.1)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    38.40 (28.1 to 50.9)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for belantamab mafodotin ADC. Treatment B - PK population

    		 Close Top of page
    End point title
    		 Cmax for belantamab mafodotin ADC. Treatment B - PK population [25]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    52.24 ( 31.87 )
    49.50 ( 21.38 )
    61.16 ( 36.74 )
    51.29 ( 26.03 )
    21.34 ( 34.67 )
    46.95 ( 23.24 )
    27.79 ( 37.28 )
    64.00 ( 38.60 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    24.46 ( 32.10 )
    88888 ( 88888 )
    31.96 ( 32.79 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC (0-504h) for belantamab mafodotin ADC, Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC (0-504h) for belantamab mafodotin ADC, Treatment B - PK population [26]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    7
    10
    4
    7
    7
    15
    8
    11
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    6129.71 ( 23.83 )
    4451.74 ( 23.33 )
    6073.99 ( 37.06 )
    5395.98 ( 20.49 )
    4341.73 ( 22.36 )
    5013.84 ( 31.91 )
    5702.03 ( 26.30 )
    6230.16 ( 35.02 )
    No statistical analyses for this end point

    Secondary: AUC (0-1008h) for belantamab mafodotin ADC, Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC (0-1008h) for belantamab mafodotin ADC, Treatment B - PK population [27]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC was derived only for STRETCH and S/D STRETCH cohorts. Only those participants with data available at specified time points have been analyzed. As per protocol, blood sampling for PK was performed for only specified treatment arms for this OM and hence there are 0 participants analyzed for rest of the arms.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre Pre-Dose and Post-Dose on Week 5 Day 7
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    5
    0 [28]
    10
    6
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    7084.63 ( 24.82 )
    ( )
    7396.49 ( 25.94 )
    6487.41 ( 26.24 )
    ( )
    ( )
    ( )
    ( )
    Notes
    [28] - As pre-specified in protocol
    [29] - As pre-specified in protocol
    [30] - As pre-specified in protocol
    [31] - As pre-specified in protocol
    [32] - As pre-specified in protocol
    No statistical analyses for this end point

    Secondary: Tmax for belantamab mafodotin ADC, Treatment B - PK population

    		 Close Top of page
    End point title
    		 Tmax for belantamab mafodotin ADC, Treatment B - PK population [33]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Hour
    median (full range (min-max))
        CYCLE 1 DAY 1
    1.900 (0.63 to 22.50)
    1.125 (0.55 to 2.62)
    2.025 (0.63 to 25.95)
    1.175 (0.62 to 2.57)
    1.233 (0.50 to 2.22)
    1.308 (0.45 to 2.70)
    0.583 (0.50 to 2.20)
    2.000 (0.52 to 3.83)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.733 (0.52 to 336.75)
    88888 (88888 to 88888)
    0.642 (0.40 to 2.05)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: tlast for belantamab mafodotin ADC, Treatment B - PK population

    		 Close Top of page
    End point title
    		 tlast for belantamab mafodotin ADC, Treatment B - PK population [34]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 hour on Cycle 1 Day 1
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Hour
        median (full range (min-max))
    540.250 (75.67 to 1052.33)
    505.592 (503.75 to 1220.95)
    1009.933 (500.93 to 1489.00)
    755.442 (22.68 to 2018.57)
    504.567 (144.83 to 1351.17)
    506.817 (167.50 to 577.33)
    503.458 (239.72 to 1584.50)
    506.092 (2.00 to 2022.58)
    No statistical analyses for this end point

    Secondary: Ctrough for belantamab mafodotin ADC, Treatment B - PK population

    		 Close Top of page
    End point title
    		 Ctrough for belantamab mafodotin ADC, Treatment B - PK population [35]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    1.12 (0.5 to 1.5)
    1.92 (0.6 to 3.9)
    0.63 (0.5 to 1.2)
    0.84 (0.5 to 1.0)
    3.50 (1.8 to 7.1)
    2.12 (1.1 to 5.4)
    4.25 (1.6 to 11.7)
    2.10 (0.5 to 4.3)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    3.72 (0.7 to 24.3)
    88888 (88888 to 88888)
    3.93 (1.7 to 9.0)
    88888 (88888 to 88888)
        WEEK 4 DAY 1
    88888 (88888 to 88888)
    3.23 (1.4 to 5.4)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    4.39 (3.0 to 8.6)
    1.32 (0.6 to 8.6)
    3.62 (1.4 to 6.2)
    2.53 (0.6 to 4.3)
        WEEK 7 DAY 1
    77777 (77777 to 77777)
    3.90 (0.5 to 6.4)
    1.24 (0.6 to 2.8)
    77777 (77777 to 77777)
    5.85 (4.0 to 8.1)
    2.72 (0.1 to 3.7)
    10.10 (5.7 to 13.9)
    88888 (88888 to 88888)
        WEEK 10 DAY 1
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    1.40 (0.7 to 2.1)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: C-EOI for belantamab mafodotin ADC, Treatment B - PK population

    		 Close Top of page
    End point title
    		 C-EOI for belantamab mafodotin ADC, Treatment B - PK population [36]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8; Week 7 Day 8, Week 7 Day 11, Week 10 Day 8
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    44.75 (26.8 to 68.0)
    44.05 (36.1 to 61.5)
    52.00 (22.8 to 88.8)
    45.25 (31.4 to 76.7)
    22.30 (12.9 to 30.6)
    45.80 (29.1 to 57.6)
    30.10 (11.0 to 49.1)
    54.85 (37.2 to 215.0)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    22.60 (12.2 to 48.4)
    88888 (88888 to 88888)
    32.60 (17.5 to 55.7)
    88888 (88888 to 88888)
        WEEK 4 DAY 1
    88888 (88888 to 88888)
    46.00 (30.5 to 64.0)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    27.10 (16.7 to 32.4)
    44.50 (26.8 to 254.0)
    26.20 (14.6 to 53.2)
    51.20 (45.7 to 57.8)
        WEEK 7 DAY 1
    48.60 (37.9 to 83.6)
    44.30 (3.4 to 71.8)
    36.45 (26.5 to 76.9)
    42.50 (25.9 to 84.1)
    26.30 (19.1 to 29.7)
    31.70 (18.2 to 62.7)
    27.40 (12.1 to 38.6)
    38.35 (37.0 to 55.8)
        WEEK 7 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
        WEEK 7 DAY 11
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
        WEEK 10 DAY 1
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    38.00 (31.9 to 43.3)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 10 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    43.30 (31.1 to 60.1)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    46.60 (41.4 to 62.3)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Cmax for belantamab mafodotin (Total Antibody), Treatment A - PK population [37]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    16
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    43.09 ( 22.26 )
    40.18 ( 13.23 )
    26.64 ( 14.97 )
    46.95 ( 30.63 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    35.11 ( 13.68 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment A - PK population [38]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21
    Notes
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    4
    10
    9
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    6648.19 ( 35.67 )
    6607.45 ( 35.62 )
    6909.91 ( 24.70 )
    7277.25 ( 28.00 )
    No statistical analyses for this end point

    Secondary: AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-672h) for belantamab mafodotin (Total Antibody), Treatment A - PK population [39]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 28
    Notes
    [39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    4
    10
    9
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    7408.65 ( 36.03 )
    7249.58 ( 39.00 )
    7828.12 ( 27.15 )
    8146.00 ( 28.29 )
    No statistical analyses for this end point

    Secondary: AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment A - PK population [40]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7
    Notes
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Number of subjects analysed
    5
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    8143.85 ( 30.12 )
    No statistical analyses for this end point

    Secondary: AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC(0-1344h) for belantamab mafodotin (Total Antibody), Treatment A - PK population [41]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determinedusing standard non-compartmental methods. AUC(0-1344) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 7 Day 7
    Notes
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Number of subjects analysed
    5
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    8633.05 ( 30.26 )
    No statistical analyses for this end point

    Secondary: Tmax for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Tmax for belantamab mafodotin (Total Antibody), Treatment A - PK population [42]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    16
    Units: Hour
    median (full range (min-max))
        CYCLE 1 DAY 1
    1.267 (0.57 to 2.37)
    1.342 (0.50 to 2.17)
    1.033 (0.57 to 2.20)
    2.000 (0.53 to 2.82)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    1.583 (0.57 to 2.10)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: tlast for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 tlast for belantamab mafodotin (Total Antibody), Treatment A - PK population [43]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1 and Cycle 1 Day 8; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 15-21; Cycle 1 Day 29; pre-dose Cycle 2 Day 28; pre-dose Cycle 3 Day 8
    Notes
    [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    16
    Units: Hour
        median (full range (min-max))
    657.267 (25.50 to 1439.63)
    685.875 (673.92 to 697.75)
    674.833 (670.60 to 1416.93)
    673.625 (2.00 to 1534.15)
    No statistical analyses for this end point

    Secondary: Ctrough for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Ctrough for belantamab mafodotin (Total Antibody), Treatment A - PK population [44]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
    Notes
    [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    4
    12
    12
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    0.81 (0.6 to 2.0)
    3.39 (0.7 to 6.1)
    7.74 (1.9 to 9.9)
    3.16 (1.6 to 5.9)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    3.99 (0.9 to 12.3)
    88888 (88888 to 88888)
        WEEK 5 DAY 1
    88888 (88888 to 88888)
    2.76 (1.1 to 8.1)
    12.40 (7.7 to 22.6)
    1.82 (0.8 to 4.5)
        WEEK 5 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    6.16 (2.5 to 22.6)
    88888 (88888 to 88888)
        WEEK 9 DAY 1
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    15.25 (11.2 to 29.7)
    77777 (77777 to 77777)
        WEEK 9 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    10.50 (1.3 to 10.5)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    10.70 (0.9 to 17.0)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: C-EOI for belantamab mafodotin (Total Antibody), Treatment A - PK population

    		 Close Top of page
    End point title
    		 C-EOI for belantamab mafodotin (Total Antibody), Treatment A - PK population [45]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 5 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
    Notes
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    10
    4
    13
    16
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    42.70 (35.0 to 64.0)
    36.90 (35.3 to 47.9)
    27.25 (20.1 to 32.7)
    47.00 (17.2 to 64.2)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    35.00 (27.8 to 40.3)
    88888 (88888 to 88888)
        WEEK 5 DAY 1
    88888 (88888 to 88888)
    42.15 (32.4 to 48.1)
    27.00 (24.7 to 36.4)
    45.70 (30.0 to 79.9)
        WEEK 5 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    36.40 (27.8 to 50.6)
    88888 (88888 to 88888)
        WEEK 9 DAY 1
    41.80 (33.1 to 52.9)
    77777 (77777 to 77777)
    31.25 (22.9 to 46.6)
    77777 (77777 to 77777)
        WEEK 9 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    39.20 (27.4 to 56.8)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    50.10 (39.5 to 73.3)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for belantamab mafodotin (Total Antibody) Treatment B - PK population

    		 Close Top of page
    End point title
    		 Cmax for belantamab mafodotin (Total Antibody) Treatment B - PK population [46]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    10
    12
    12
    13
    17
    11
    16
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    41.28 ( 16.86 )
    37.47 ( 12.02 )
    53.29 ( 23.50 )
    53.85 ( 12.54 )
    22.92 ( 35.83 )
    50.32 ( 30.03 )
    31.06 ( 20.02 )
    78.29 ( 36.16 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    29.47 ( 40.48 )
    88888 ( 88888 )
    45.31 ( 39.57 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC (0-504h) for belantamab mafodotin (Total Antibody), Treatment B - PK population [47]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 21
    Notes
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    8
    6
    4
    6
    8
    12
    7
    11
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    7310.17 ( 37.27 )
    6094.55 ( 33.37 )
    8386.87 ( 25.44 )
    9891.43 ( 29.93 )
    8283.76 ( 32.51 )
    8207.69 ( 41.72 )
    9812.19 ( 27.13 )
    12581.08 ( 28.13 )
    No statistical analyses for this end point

    Secondary: AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC (0-1008h) for belantamab mafodotin (Total Antibody), Treatment B - PK population [48]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9 mg/kg+ Bor/Dax STRETCH, Belantamab mafodotin 2.5 mg/kg+ Bor/Dax StepDown STRETCH and STRETCH cohorts.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0, 2 and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 11; Cycle 1 Day 22; Pre-Dose and Post-Dose on Week 5 Day 7
    Notes
    [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
    Number of subjects analysed
    5
    11
    10
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    11656.56 ( 25.11 )
    11328.37 ( 40.25 )
    11178.97 ( 49.10 )
    No statistical analyses for this end point

    Secondary: Tmax for belantamab mafodotin (Total Antibody), Treatment B - PK population

    		 Close Top of page
    End point title
    		 Tmax for belantamab mafodotin (Total Antibody), Treatment B - PK population [49]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    10
    12
    12
    13
    17
    11
    16
    Units: Hour
    median (full range (min-max))
        CYCLE 1 DAY 1
    1.900 (0.75 to 2.03)
    2.033 (0.70 to 2.23)
    0.983 (0.57 to 2.13)
    1.142 (0.62 to 2.58)
    2.000 (0.50 to 2.17)
    1.983 (0.45 to 2.23)
    0.650 (0.50 to 2.13)
    2.000 (0.52 to 2.50)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.700 (0.52 to 2.50)
    88888 (88888 to 88888)
    0.617 (0.40 to 2.05)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: tlast for belantamab mafodotin (Total Antibody), Treatment B - PK population

    		 Close Top of page
    End point title
    		 tlast for belantamab mafodotin (Total Antibody), Treatment B - PK population [50]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 hour on Cycle 1 Day 1
    Notes
    [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Hour
        median (full range (min-max))
    585.958 (75.67 to 2855.48)
    504.983 (239.92 to 2155.95)
    1414.500 (505.25 to 3694.62)
    1031.467 (1006.72 to 4054.38)
    504.583 (144.83 to 1351.17)
    505.483 (167.50 to 671.65)
    502.883 (239.72 to 717.68)
    506.808 (2.00 to 2832.25)
    No statistical analyses for this end point

    Secondary: Ctrough for belantamab mafodotin (Total Antibody), Treatment B - PK population

    		 Close Top of page
    End point title
    		 Ctrough for belantamab mafodotin (Total Antibody), Treatment B - PK population [51]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
    Notes
    [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    4
    10
    9
    11
    12
    14
    12
    15
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    3.13 (1.0 to 5.6)
    5.27 (2.1 to 10.7)
    1.53 (1.1 to 4.5)
    1.32 (0.6 to 8.6)
    5.88 (1.2 to 13.5)
    7.22 (1.7 to 17.2)
    9.59 (3.5 to 38.9)
    6.82 (1.4 to 17.4)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    12.30 (2.7 to 33.2)
    88888 (88888 to 88888)
    12.05 (7.8 to 22.6)
    88888 (88888 to 88888)
        WEEK 4 DAY 1
    88888 (88888 to 88888)
    7.97 (0.6 to 18.8)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    14.95 (1.2 to 27.7)
    3.62 (0.6 to 22.8)
    11.20 (5.3 to 25.1)
    5.27 (1.9 to 13.2)
        WEEK 7 DAY 1
    77777 (77777 to 77777)
    7.66 (2.6 to 22.2)
    1.72 (1.4 to 6.5)
    2.32 (1.9 to 5.8)
    19.40 (10.3 to 34.0)
    1.35 (1.1 to 21.7)
    26.00 (19.1 to 31.0)
    88888 (88888 to 88888)
        WEEK 7 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
        WEEK 10 DAY 1
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    3.07 (1.4 to 3.4)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    5.26 (1.3 to 10.5)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: C-EOI for belantamab mafodotin (Total Antibody), Treatment B - PK population

    		 Close Top of page
    End point title
    		 C-EOI for belantamab mafodotin (Total Antibody), Treatment B - PK population [52]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 13 Day 1, Week 13 Day 8
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    11
    11
    12
    12
    12
    16
    11
    15
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    36.60 (30.7 to 52.0)
    36.75 (27.6 to 44.0)
    52.55 (38.2 to 90.3)
    51.65 (43.7 to 66.1)
    23.90 (13.9 to 33.1)
    44.35 (30.3 to 63.0)
    33.40 (21.2 to 40.1)
    68.80 (42.5 to 241.0)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    24.95 (16.1 to 38.2)
    88888 (88888 to 88888)
    42.50 (25.7 to 98.9)
    88888 (88888 to 88888)
        WEEK 4 DAY 1
    88888 (88888 to 88888)
    39.20 (24.6 to 54.6)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    37.00 (19.8 to 46.0)
    59.50 (30.1 to 233.0)
    39.40 (19.6 to 70.8)
    67.85 (50.0 to 85.5)
        WEEK 7 DAY 1
    36.50 (31.8 to 67.8)
    43.00 (14.3 to 78.6)
    37.30 (23.3 to 65.1)
    47.50 (33.3 to 67.7)
    42.00 (24.0 to 49.5)
    50.75 (29.6 to 73.8)
    33.90 (20.2 to 63.0)
    63.95 (44.5 to 67.6)
        WEEK 7 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
        WEEK 7 DAY 11
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
        WEEK 10 DAY 1
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    42.70 (41.0 to 53.6)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
        WEEK 10 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    33.30 (27.8 to 41.6)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    54.50 (52.9 to 85.3)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for belantamab mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Cmax for belantamab mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF), Treatment A - PK population [53]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    11
    4
    12
    13
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    1.11 ( 70.59 )
    0.55 ( 53.90 )
    0.53 ( 48.23 )
    1.18 ( 53.35 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    0.63 ( 28.28 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC (0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population [54]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4 and Cycle 1 Day 7
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    9
    1
    11
    10
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    106.21 ( 55.99 )
    88888 ( 88888 )
    43.15 ( 26.42 )
    113.58 ( 49.61 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    51.31 ( 30.45 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC (0-336h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-336h) for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population [55]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC (0-336h) was derived only for the Belantamab mafodotin 2.5mg/kg + Len/Dex SPLIT cohort.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 11; Cycle 1 Day 14
    Notes
    [55] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
    Number of subjects analysed
    8
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    93.84 ( 29.16 )
    No statistical analyses for this end point

    Secondary: Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population [56]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    11
    4
    12
    13
    Units: Hour
    median (full range (min-max))
        CYCLE 1 DAY 1
    24.217 (1.42 to 28.58)
    24.900 (23.67 to 73.42)
    23.667 (1.00 to 25.42)
    24.367 (2.23 to 25.92)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    23.425 (0.57 to 25.93)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: tlast for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

    		 Close Top of page
    End point title
    		 tlast for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population [57]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 hour on Cycle 1 Day 1
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    12
    4
    13
    14
    Units: Hour
        median (full range (min-max))
    165.567 (25.50 to 357.02)
    120.283 (49.97 to 191.58)
    336.900 (94.40 to 360.17)
    166.167 (2.08 to 239.17)
    No statistical analyses for this end point

    Secondary: C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population

    		 Close Top of page
    End point title
    		 C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment A - PK population [58]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 5 Day 1, Week 7 Day 8, Week 9 Day 1, Week 9 Day 8, Week 13 Day 1, Week 13 Day 8
    Notes
    [58] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    11
    4
    13
    14
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    0.43 (0.3 to 1.6)
    0.187 (0.160 to 0.290)
    0.19 (0.1 to 1.3)
    0.29 (0.1 to 1.3)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.29 (0.2 to 0.9)
    88888 (88888 to 88888)
        WEEK 5 DAY 1
    88888 (88888 to 88888)
    0.16 (0.1 to 0.4)
    0.13 (0.1 to 0.3)
    0.28 (0.2 to 1.0)
        WEEK 5 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.23 (0.2 to 0.4)
    88888 (88888 to 88888)
        WEEK 9 DAY 1
    0.29 (0.2 to 0.5)
    77777 (77777 to 77777)
    0.13 (0.1 to 0.7)
    77777 (77777 to 77777)
        WEEK 9 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.24 (0.2 to 0.4)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    0.68 (0.2 to 0.9)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.243 (0.207 to 0.248)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for belantamab mafodotin (Cys-mcMMAF) Treatment B - PK population

    		 Close Top of page
    End point title
    		 Cmax for belantamab mafodotin (Cys-mcMMAF) Treatment B - PK population [59]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [59] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    12
    12
    12
    11
    11
    11
    9
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        CYCLE 1 DAY 1
    0.73 ( 29.88 )
    0.75 ( 68.94 )
    1.03 ( 52.77 )
    1.29 ( 38.95 )
    0.65 ( 87.99 )
    1.15 ( 57.18 )
    1.03 ( 38.56 )
    1.09 ( 40.30 )
        CYCLE 1 DAY 8
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
    0.58 ( 87.48 )
    88888 ( 88888 )
    0.86 ( 64.55 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC(0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC(0-168h) for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population [60]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 2, and 24 Hours Post Dose on Cycle 1 Day 1, Cycle 1 Day 4; and Cycle 1 Day 7
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Number of subjects analysed
    8
    9
    10
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    89.05 ( 41.52 )
    52.82 ( 96.74 )
    81.17 ( 31.46 )
    No statistical analyses for this end point

    Secondary: Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

    		 Close Top of page
    End point title
    		 Tmax for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population [61]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8
    Notes
    [61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    12
    12
    12
    11
    11
    11
    9
    Units: Hour
    median (full range (min-max))
        CYCLE 1 DAY 1
    22.225 (22.07 to 24.77)
    24.475 (1.00 to 25.75)
    23.092 (22.00 to 25.95)
    22.442 (1.17 to 74.02)
    24.083 (19.30 to 77.37)
    24.083 (2.07 to 25.25)
    24.583 (22.97 to 70.28)
    24.667 (21.85 to 25.72)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    24.000 (0.92 to 25.30)
    88888 (88888 to 88888)
    23.717 (2.58 to 25.60)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: tlast for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

    		 Close Top of page
    End point title
    		 tlast for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population [62]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 hour on Cycle 1 Day 1
    Notes
    [62] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Hour
        median (full range (min-max))
    85.542 (68.57 to 262.25)
    239.800 (72.33 to 243.90)
    237.992 (70.58 to 265.82)
    93.942 (67.95 to 242.77)
    241.283 (146.33 to 527.50)
    237.425 (70.53 to 241.58)
    240.675 (237.55 to 503.73)
    171.567 (2.00 to 266.87)
    No statistical analyses for this end point

    Secondary: C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population

    		 Close Top of page
    End point title
    		 C-EOI for belantamab mafodotin (Cys-mcMMAF), Treatment B - PK population [63]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected. 77777= As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0, 2 and 24 Hour on Cycle 1 Day 1 and Cycle 1 Day 8; Pre-Dose and Post-Dose on Week 4 Day 1, Week 7 Day 1, Week 7 Day 8, Week 7 Day 11, Week 10 Day 1, Week 10 Day 8, Week 13 Day 1, Week 13 Day 8
    Notes
    [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    12
    12
    12
    13
    17
    11
    15
    Units: ug/mL
    median (full range (min-max))
        CYCLE 1 DAY 1
    0.29 (0.1 to 0.5)
    0.21 (0.1 to 2.7)
    0.28 (0.2 to 0.6)
    0.32 (0.1 to 1.4)
    0.19 (0.1 to 0.7)
    0.29 (0.1 to 0.8)
    0.27 (0.1 to 0.8)
    0.39 (0.2 to 0.6)
        CYCLE 1 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.27 (0.1 to 1.5)
    88888 (88888 to 88888)
    0.40 (0.2 to 0.9)
    88888 (88888 to 88888)
        WEEK 4 DAY 1
    88888 (88888 to 88888)
    0.19 (0.1 to 0.4)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.21 (0.1 to 0.4)
    0.35 (0.1 to 1.5)
    0.26 (0.2 to 0.6)
    0.35 (0.2 to 0.9)
        WEEK 7 DAY 1
    0.20 (0.1 to 0.4)
    0.21 (0.1 to 0.3)
    0.17 (0.1 to 0.2)
    0.31 (0.1 to 0.9)
    0.27 (0.1 to 0.4)
    0.24 (0.1 to 0.9)
    0.20 (0.2 to 0.4)
    0.36 (0.2 to 0.4)
        WEEK 7 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
        WEEK 7 DAY 11
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
        WEEK 10 DAY 1
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    0.236 (0.188 to 0.238)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    99999 (99999 to 99999)
        WEEK 10 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
        WEEK 13 DAY 1
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    0.222 (0.118 to 0.240)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    77777 (77777 to 77777)
    0.24 (0.1 to 0.3)
        WEEK 13 DAY 8
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    77777 (77777 to 77777)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for Lenalidomide (25 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Cmax for Lenalidomide (25 mg), Treatment A - PK population [64]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    5
    4
    13
    Units: ug/mL
        geometric mean (geometric coefficient of variation)
    382.16 ( 54.52 )
    331.53 ( 17.91 )
    283.08 ( 36.55 )
    No statistical analyses for this end point

    Secondary: AUC(0-24h) for Lenalidomide (25 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC(0-24h) for Lenalidomide (25 mg), Treatment A - PK population [65]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    3
    8
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    2247.36 ( 65.76 )
    1577.62 ( 21.66 )
    2117.26 ( 38.21 )
    No statistical analyses for this end point

    Secondary: AUC (0-4h) for Lenalidomide (25 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-4h) for Lenalidomide (25 mg), Treatment A - PK population [66]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    5
    3
    9
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    812.22 ( 105.88 )
    870.92 ( 19.36 )
    620.10 ( 44.84 )
    No statistical analyses for this end point

    Secondary: Tmax for Lenalidomide (25 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Tmax for Lenalidomide (25 mg), Treatment A - PK population [67]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    5
    4
    13
    Units: Hour
        median (full range (min-max))
    0.967 (0.47 to 4.00)
    1.417 (0.93 to 2.00)
    3.767 (1.92 to 4.00)
    No statistical analyses for this end point

    Secondary: Cmax for Lenalidomide (10 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Cmax for Lenalidomide (10 mg), Treatment A - PK population [68]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [68] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    2
    Units: ug/mL
        geometric mean (geometric coefficient of variation)
    193.06 ( 36.86 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: tlast for Lenalidomide (25 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 tlast for Lenalidomide (25 mg), Treatment A - PK population [69]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    5
    4
    13
    Units: Hour
        median (full range (min-max))
    20.750 (3.80 to 24.00)
    4.000 (3.77 to 22.57)
    22.050 (3.75 to 23.55)
    No statistical analyses for this end point

    Secondary: AUC(0-24h) for Lenalidomide (10 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC(0-24h) for Lenalidomide (10 mg), Treatment A - PK population [70]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    1
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    1660.82 ( 22.40 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: AUC (0-4h) for Lenalidomide (10 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 AUC (0-4h) for Lenalidomide (10 mg), Treatment A - PK population [71]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2 and 4 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [71] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    2
    Units: h*ug/mL
        geometric mean (geometric coefficient of variation)
    486.46 ( 41.84 )
    88888 ( 88888 )
    No statistical analyses for this end point

    Secondary: tlast for Lenalidomide (10 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 tlast for Lenalidomide (10 mg), Treatment A - PK population [72]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    2
    Units: Hour
        median (full range (min-max))
    21.583 (21.27 to 23.68)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Tmax for Lenalidomide (10 mg), Treatment A - PK population

    		 Close Top of page
    End point title
    		 Tmax for Lenalidomide (10 mg), Treatment A - PK population [73]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = As pre-specified in the SAP, data is not reported if the number of participants analyzed is less than 3.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, 0.5, 1, 2, 4 and 24 hours on Cycle 1 Day 1 post lenalidomide dose
    Notes
    [73] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Number of subjects analysed
    4
    2
    Units: Hour
        median (full range (min-max))
    2.000 (0.53 to 3.80)
    88888 (88888 to 88888)
    No statistical analyses for this end point

    Secondary: Cmax for Bortezomib, Treatment B - PK population

    		 Close Top of page
    End point title
    		 Cmax for Bortezomib, Treatment B - PK population [74]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-Dose, Post-Dose 0.5, 1, 2, 4 and 24 Hour on Cycle 1 Day 1
    Notes
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    11
    15
    15
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        INTRAVENOUS
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        SUBCUTANEOUS
    14.45 ( 50.16 )
    14.89 ( 44.03 )
    15.88 ( 42.07 )
    No statistical analyses for this end point

    Secondary: AUC (0-72h) for Bortezomib, Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC (0-72h) for Bortezomib, Treatment B - PK population [75]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
    Notes
    [75] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    11
    14
    13
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Intravenous
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        Subcutaneous
    95.10 ( 21.71 )
    73.03 ( 30.79 )
    73.06 ( 21.57 )
    No statistical analyses for this end point

    Secondary: AUC (0-t) for Bortezomib, Treatment B - PK population

    		 Close Top of page
    End point title
    		 AUC (0-t) for Bortezomib, Treatment B - PK population [76]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
    Notes
    [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    11
    15
    15
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Intravenous
    88888 ( 88888 )
    88888 ( 88888 )
    88888 ( 88888 )
        Subcutaneous
    89.48 ( 25.50 )
    69.51 ( 31.87 )
    71.70 ( 26.79 )
    No statistical analyses for this end point

    Secondary: Tmax for Bortezomib, Treatment B - PK population

    		 Close Top of page
    End point title
    		 Tmax for Bortezomib, Treatment B - PK population [77]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
    Notes
    [77] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    11
    15
    15
    Units: Hour
    median (full range (min-max))
        Intravenous
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
        Subcutaneous
    0.533 (0.10 to 1.07)
    0.517 (0.25 to 1.00)
    0.500 (0.08 to 1.00)
    No statistical analyses for this end point

    Secondary: tlast for Bortezomib, Treatment B - PK population

    		 Close Top of page
    End point title
    		 tlast for Bortezomib, Treatment B - PK population [78]
    End point description
    Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods. 88888 = Data was not collected.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 5 minute, 0.25, 0.5, 1, 2, 4, 6, 10, 24, 48 and 72 hour post bortezomib dose
    Notes
    [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment B arms only.
    End point values
    		 Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    11
    16
    15
    Units: Hour
    median (full range (min-max))
        Intravenous
    88888 (88888 to 88888)
    88888 (88888 to 88888)
    88888 (88888 to 88888)
        Subcutaneous
    68.867 (44.07 to 72.00)
    68.392 (44.35 to 73.10)
    48.000 (46.17 to 75.65)
    No statistical analyses for this end point

    Secondary: Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin - All treated population

    		 Close Top of page
    End point title
    		 Number of participants with anti-drug antibodies (ADAs) against belantamab mafodotin - All treated population
    End point description
    Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
    End point type
    Secondary
    End point timeframe
    Up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    3
    13
    15
    12
    12
    12
    12
    12
    18
    11
    16
    Units: Participants
        Baseline
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
        End of Treatment
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Titers of ADAs Against Belantamab Mafodotin - All treated population

    		 Close Top of page
    End point title
    		 Titers of ADAs Against Belantamab Mafodotin - All treated population [79]
    End point description
    Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titer is defined as the reciprocal of the highest dilution that yield results at or above the plate-based titer cut point x MRD.
    End point type
    Secondary
    End point timeframe
    Up to approximately 4.5 years
    Notes
    [79] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoints are different for the different parts of the study. Hence, for this endpoint, results were presented for Treatment A arms only.
    End point values
    		 Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Number of subjects analysed
    1
    1
    1
    Units: Titers
        median (full range (min-max))
    100 (100 to 100)
    100 (100 to 100)
    100 (100 to 100)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Ocular Surface Disease Index (OSDI) Total Scores - All treated population

    		 Close Top of page
    End point title
    		 Change from Baseline in Ocular Surface Disease Index (OSDI) Total Scores - All treated population
    End point description
    The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. OSDI consist of three subscales (ocular symptoms: item 1-3; visual related function: item 4-9; environmental triggers: item 10-12). Each item will be graded on a scale of 0 (none of the time or lower disability) to 4 (all of the time or greater disability) with total scores ranging from 0 (no disability) to 100 (complete disability). The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Higher scores indicated greater disability. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    9
    4
    11
    12
    12
    9
    12
    9
    10
    15
    9
    14
    Units: Score on scale
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    11.1 ( 7.58 )
    0.8 ( 1.56 )
    7.8 ( 9.30 )
    11.4 ( 14.26 )
    10.8 ( 17.20 )
    2.4 ( 2.79 )
    7.8 ( 9.94 )
    8.0 ( 5.66 )
    12.4 ( 16.42 )
    6.3 ( 7.71 )
    8.6 ( 13.61 )
    3.3 ( 5.58 )
        End of Treatment
    -5.2 ( 4.42 )
    0.6 ( 4.10 )
    6.9 ( 12.03 )
    2.2 ( 7.19 )
    15.2 ( 35.94 )
    15.9 ( 14.80 )
    18.7 ( 34.95 )
    29.3 ( 39.18 )
    6.1 ( 8.59 )
    14.4 ( 23.26 )
    48.3 ( 27.42 )
    19.3 ( 14.41 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores - All treated population

    		 Close Top of page
    End point title
    		 Change from Baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Scores - All treated population
    End point description
    The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the patient's perception of vision-related functioning and vision-related quality of life. Items were coded to a 0 to 100 scale and were averaged to calculate domains. The composite score ranges from 0 (worst score) to 100 (best score), with higher scores indicating better vision-related functioning. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. 77777 = standard deviation (SD) could not be calculated for a single participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    3
    11
    12
    11
    8
    9
    8
    7
    11
    7
    10
    Units: Score on scale
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    85.1 ( 11.42 )
    89.0 ( 18.43 )
    91.9 ( 10.88 )
    91.0 ( 11.35 )
    88.0 ( 16.92 )
    95.5 ( 4.70 )
    96.2 ( 5.20 )
    95.3 ( 4.60 )
    90.4 ( 7.67 )
    94.1 ( 8.33 )
    93.2 ( 7.13 )
    94.7 ( 5.59 )
        End of Treatment
    0.2 ( 13.53 )
    12.9 ( 22.42 )
    -4.5 ( 4.04 )
    -1.9 ( 3.43 )
    1.1 ( 19.48 )
    -8.4 ( 13.65 )
    -18.3 ( 19.96 )
    -26.0 ( 31.54 )
    1.3 ( 77777 )
    -13.2 ( 25.00 )
    -48.9 ( 2.35 )
    -11.5 ( 15.39 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - All treated population
    End point description
    The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE like Anxious, Blurred Vision, Chills, Concentration, Constipation, Cough, Decreased Appetite, Discouraged, Dizziness, Fatigue, Heart Palpitations, Insomnia, Memory, Mouth/Throat Sores, Nausea, Nosebleed, Numbness & Tingling, Pain, Ringing In Ears, Shortness Of Breath, Vomiting and Watery Eyes. Number of participants with symptomatic AEs are presented.
    End point type
    Secondary
    End point timeframe
    Up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Anxious
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Blurred Vision
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Chills
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Concentration
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Constipation
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Cough
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Decreased Appetite
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Discouraged
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Dizziness
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Fatigue
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Heart Palpitations
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Insomnia
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Memory
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Mouth/Throat Sores
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Nausea
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Nosebleed
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Numbness & tingling
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Pain
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Ringing In Ears
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Shortness Of Breath
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Vomiting
    8
    4
    13
    13
    8
    12
    12
    11
    11
    17
    10
    15
        Watery Eyes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with AEs of special interest (AESI) - All treated population

    		 Close Top of page
    End point title
    		 Number of participants with AEs of special interest (AESI) - All treated population
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI for belantamab mafodotin (corneal events, thrombocytopenia and infusion related reactions) are presented.
    End point type
    Secondary
    End point timeframe
    Up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Corneal Events
    9
    3
    12
    11
    9
    12
    12
    12
    10
    17
    10
    16
        Thrombocytopenia
    4
    2
    7
    11
    9
    12
    10
    11
    11
    13
    12
    14
        Infusion Related Reactions
    1
    0
    2
    3
    0
    2
    1
    2
    2
    3
    3
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores - All treated population
    End point description
    BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline <0.12 logMAR score; a possible worsened vision was defined as a change from baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from baseline >=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    9
    4
    13
    14
    11
    12
    12
    12
    12
    18
    11
    16
    Units: Participants
        Right Eye|No change/improved vision
    2
    2
    5
    3
    4
    3
    2
    2
    4
    3
    2
    1
        Left Eye|No change/improved vision
    2
    1
    2
    4
    4
    1
    2
    5
    4
    3
    3
    2
        Right Eye|Possible worsened vision
    3
    0
    0
    2
    2
    2
    0
    4
    2
    2
    5
    5
        Left Eye|Possible worsened vision
    2
    0
    2
    1
    0
    3
    5
    1
    2
    3
    2
    6
        Right Eye|Definite worsened vision
    4
    2
    8
    9
    5
    7
    10
    6
    6
    13
    4
    10
        Left Eye|Definite worsened vision
    5
    3
    9
    9
    7
    8
    5
    6
    6
    12
    6
    8
    No statistical analyses for this end point

    Secondary: Number of Participants With Worst-case post-baseline Change in BCVA Scores by Snellen results - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worst-case post-baseline Change in BCVA Scores by Snellen results - All treated population
    End point description
    BCVA score was assessed individually for better seeing eye and worse seeing eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change post baseline categories are presented for better eye and worse eye. BCVA test scores by Snellen results were categorized as improved BCVA, <= 2 lines decline in visual acuity from baseline, >= 3 lines decline in visual acuity from baseline. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    9
    4
    13
    14
    11
    12
    12
    12
    12
    18
    11
    16
    Units: Participants
        Better Eye|Improved BCVA
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
        Worse Eye|Improved BCVA
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
        Better Eye|<=2 Lines decline
    8
    3
    9
    11
    7
    7
    10
    8
    9
    8
    9
    12
        Worse Eye|<=2 Lines decline
    5
    3
    4
    5
    6
    5
    8
    7
    6
    6
    7
    8
        Better Eye|>=3 Lines decline
    1
    1
    3
    3
    4
    5
    2
    4
    2
    9
    2
    4
        Worse Eye|>=3 Lines decline
    4
    1
    8
    9
    4
    7
    4
    5
    5
    12
    4
    8
    No statistical analyses for this end point

    Secondary: Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception - All treated population
    End point description
    Number of participants with a Decline in BCVA to 'Light Perception (LP)' or 'No Light Perception (NLP)' due to a Corneal Event Anytime Post-Baseline are presented. BCVA score was assessed individually for each eye. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Number of participants analyzed were who have any post-baseline BCVA score, where the Visual Acuity is due to corneal findings.
    End point type
    Secondary
    End point timeframe
    Baseline and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    9
    3
    10
    11
    11
    10
    12
    11
    8
    11
    8
    10
    Units: Participants
        Left Eye, LP
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Left Eye, NLP
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Right Eye, LP
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Right Eye, NLP
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline) - All treated population
    End point description
    Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    12
    4
    13
    16
    12
    12
    12
    12
    13
    18
    12
    16
    Units: Participants
        Active Edema, Right Eye
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
        Active Edema, Left Eye
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
        Active Opacity, Right Eye
    0
    0
    0
    3
    0
    0
    0
    0
    0
    3
    0
    1
        Active Opacity, Left Eye
    0
    1
    1
    2
    0
    0
    0
    0
    0
    2
    0
    1
        Corneal Neovascularization, Right Eye
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
        Corneal Neovascularization, Left Eye
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
        Corneal Ulcer, Right Eye
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
        Corneal Ulcer, Left Eye
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
        Epithelial Microcystic Edema, Right Eye
    2
    1
    3
    6
    2
    3
    3
    3
    3
    9
    3
    9
        Epithelial Microcystic Edema, Left Eye
    2
    2
    2
    6
    4
    3
    4
    2
    4
    8
    3
    9
        Subepithelial Haze, Right Eye
    3
    1
    5
    8
    5
    8
    3
    6
    5
    9
    8
    9
        Subepithelial Haze, Left Eye
    3
    2
    6
    9
    6
    9
    5
    4
    4
    10
    8
    10
    No statistical analyses for this end point

    Secondary: Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings - All treated population

    		 Close Top of page
    End point title
    		 Number of Participants With Worse Grade Post-baseline Punctate Keratopathy Findings - All treated population
    End point description
    Participants with worse grade punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    9
    4
    13
    14
    11
    12
    12
    12
    12
    18
    11
    16
    Units: Participants
        Right Eye|None
    2
    0
    2
    0
    0
    1
    0
    0
    2
    0
    1
    1
        Left Eye|None
    1
    0
    2
    0
    2
    2
    0
    0
    2
    0
    1
    0
        Worst eye|None
    1
    0
    2
    0
    0
    1
    0
    0
    2
    0
    1
    0
        Right Eye|Mild
    1
    2
    5
    6
    5
    3
    5
    1
    2
    3
    2
    2
        Left Eye|Mild
    3
    2
    1
    4
    5
    3
    5
    2
    1
    3
    2
    2
        Worst eye|Mild
    1
    2
    1
    4
    5
    3
    5
    1
    1
    2
    2
    2
        Right Eye|Moderate
    5
    2
    3
    6
    5
    7
    4
    7
    5
    9
    6
    9
        Left Eye|Moderate
    4
    2
    9
    6
    3
    5
    5
    5
    7
    9
    6
    10
        Worst eye|Moderate
    6
    2
    7
    6
    5
    6
    3
    6
    6
    10
    6
    9
        Right Eye|Severe
    1
    0
    3
    2
    1
    1
    3
    4
    3
    6
    2
    4
        Left Eye|Severe
    1
    0
    1
    4
    1
    2
    2
    5
    2
    6
    2
    4
        Worst eye|Severe
    1
    0
    3
    4
    1
    2
    4
    5
    3
    6
    2
    5
    No statistical analyses for this end point

    Secondary: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score - All treated population

    		 Close Top of page
    End point title
    		 Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score - All treated population
    End point description
    The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline (CFB) was calculated by subtracting Baseline value from the post-dose visit value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    3
    10
    8
    12
    9
    11
    11
    9
    10
    10
    8
    Units: Score on scale
    arithmetic mean (standard deviation)
        GHS/QoL, Baseline (Day 1)
    65.8 ( 25.29 )
    69.4 ( 31.55 )
    58.3 ( 14.16 )
    60.4 ( 13.18 )
    56.2 ( 23.33 )
    67.6 ( 9.72 )
    63.6 ( 20.84 )
    56.1 ( 20.78 )
    60.2 ( 26.61 )
    55.0 ( 24.60 )
    63.3 ( 16.29 )
    67.7 ( 15.71 )
        GHS/QoL, CFB to EoT
    -50.0 ( 22.05 )
    4.2 ( 17.68 )
    -4.2 ( 14.43 )
    -16.7 ( 18.00 )
    -10.0 ( 34.05 )
    -8.3 ( 11.79 )
    0.0 ( 13.94 )
    -14.6 ( 25.88 )
    -4.2 ( 17.68 )
    -8.3 ( 9.62 )
    18.7 ( 23.94 )
    4.2 ( 20.97 )
        PF, Baseline (Day 1)
    67.3 ( 23.82 )
    88.9 ( 13.88 )
    78.7 ( 15.65 )
    73.3 ( 21.97 )
    75.0 ( 15.60 )
    84.4 ( 17.95 )
    85.5 ( 17.34 )
    70.9 ( 25.69 )
    66.7 ( 31.27 )
    78.7 ( 19.58 )
    82.0 ( 10.91 )
    89.4 ( 11.48 )
        PF, CFB to EoT
    -17.8 ( 48.23 )
    13.3 ( 18.86 )
    -6.7 ( 24.94 )
    0.0 ( 33.11 )
    -5.3 ( 22.80 )
    -10.0 ( 14.14 )
    -1.1 ( 9.81 )
    -12.5 ( 27.93 )
    3.3 ( 4.71 )
    -10.0 ( 15.87 )
    -11.7 ( 42.64 )
    -1.7 ( 12.62 )
        RF, Baseline (Day 1)
    66.7 ( 30.43 )
    88.9 ( 19.25 )
    76.7 ( 22.50 )
    72.9 ( 29.46 )
    68.1 ( 21.86 )
    72.2 ( 22.05 )
    81.8 ( 24.10 )
    57.6 ( 36.03 )
    70.4 ( 33.10 )
    73.3 ( 19.56 )
    71.7 ( 22.29 )
    89.6 ( 19.80 )
        RF, CFB to EoT
    -22.2 ( 69.39 )
    16.7 ( 23.57 )
    8.3 ( 34.69 )
    4.2 ( 34.36 )
    -6.7 ( 25.28 )
    -8.3 ( 35.36 )
    -11.1 ( 27.22 )
    0.0 ( 32.12 )
    0.0 ( 0.00 )
    -20.8 ( 34.36 )
    20.8 ( 36.96 )
    -4.2 ( 28.46 )
        EF, Baseline (Day 1)
    76.7 ( 25.40 )
    86.1 ( 4.81 )
    77.5 ( 18.02 )
    76.0 ( 16.93 )
    70.8 ( 20.87 )
    94.4 ( 7.22 )
    73.5 ( 25.50 )
    68.9 ( 28.89 )
    83.3 ( 13.18 )
    78.3 ( 17.21 )
    83.3 ( 16.20 )
    91.7 ( 8.91 )
        EF, CFB to EoT
    5.6 ( 29.27 )
    -12.5 ( 5.89 )
    0.0 ( 0.00 )
    10.4 ( 15.77 )
    3.3 ( 33.64 )
    -16.7 ( 23.57 )
    0.0 ( 11.79 )
    -6.3 ( 25.49 )
    -12.5 ( 5.89 )
    2.1 ( 14.23 )
    -12.5 ( 15.96 )
    6.3 ( 12.50 )
        CF, Baseline (Day 1)
    75.0 ( 16.20 )
    88.9 ( 9.62 )
    71.7 ( 24.91 )
    72.9 ( 21.71 )
    81.9 ( 19.41 )
    87.0 ( 13.89 )
    81.8 ( 17.41 )
    74.2 ( 15.57 )
    74.1 ( 16.90 )
    83.3 ( 22.22 )
    95.0 ( 8.05 )
    91.7 ( 12.60 )
        CF, CFB to EoT
    -16.7 ( 44.10 )
    8.3 ( 11.79 )
    16.7 ( 19.25 )
    12.5 ( 20.97 )
    -10.0 ( 25.28 )
    -16.7 ( 23.57 )
    2.8 ( 6.80 )
    0.0 ( 17.82 )
    8.3 ( 11.79 )
    -8.3 ( 21.52 )
    -16.7 ( 27.22 )
    -8.3 ( 9.62 )
        SF, Baseline (Day 1)
    71.7 ( 26.12 )
    88.9 ( 19.25 )
    80.0 ( 18.92 )
    77.1 ( 21.71 )
    76.4 ( 20.67 )
    83.3 ( 18.63 )
    77.3 ( 28.16 )
    71.2 ( 28.95 )
    72.2 ( 34.36 )
    68.3 ( 34.65 )
    73.3 ( 17.92 )
    75.0 ( 23.57 )
        SF, CFB to EoT
    -27.8 ( 63.10 )
    8.3 ( 11.79 )
    0.0 ( 23.57 )
    -12.5 ( 36.96 )
    -6.7 ( 25.28 )
    -16.7 ( 0.00 )
    -11.1 ( 22.77 )
    -27.1 ( 36.66 )
    0.0 ( 0.00 )
    8.3 ( 16.67 )
    -12.5 ( 34.36 )
    16.7 ( 19.25 )
        Fatigue, Baseline (Day 1)
    46.7 ( 23.89 )
    25.9 ( 16.97 )
    31.1 ( 8.76 )
    38.9 ( 19.70 )
    34.3 ( 19.22 )
    28.4 ( 21.60 )
    29.3 ( 13.40 )
    34.3 ( 26.51 )
    30.9 ( 30.32 )
    32.2 ( 23.10 )
    37.8 ( 25.77 )
    31.9 ( 3.93 )
        Fatigue, CFB to EoT
    3.7 ( 35.72 )
    -11.1 ( 15.71 )
    5.6 ( 6.42 )
    2.8 ( 24.64 )
    13.3 ( 28.76 )
    -11.1 ( 15.71 )
    -3.7 ( 13.46 )
    16.7 ( 33.60 )
    11.1 ( 15.71 )
    2.8 ( 18.98 )
    -2.8 ( 41.94 )
    -11.1 ( 12.83 )
        N/V, Baseline (Day 1)
    11.7 ( 15.81 )
    0.0 ( 0.00 )
    11.7 ( 15.81 )
    2.1 ( 5.89 )
    8.3 ( 15.08 )
    3.7 ( 7.35 )
    4.5 ( 7.78 )
    1.5 ( 5.03 )
    5.6 ( 8.33 )
    8.3 ( 11.79 )
    5.0 ( 8.05 )
    2.1 ( 5.89 )
        N/V, CFB to EoT
    11.1 ( 41.94 )
    0.0 ( 0.00 )
    4.2 ( 8.33 )
    -4.2 ( 8.33 )
    -6.7 ( 30.28 )
    -8.3 ( 11.79 )
    5.6 ( 17.21 )
    6.3 ( 12.40 )
    0.0 ( 0.00 )
    -4.2 ( 8.33 )
    4.2 ( 8.33 )
    0.0 ( 13.61 )
        Pain, Baseline (Day 1)
    46.7 ( 35.83 )
    22.2 ( 25.46 )
    36.7 ( 24.60 )
    37.5 ( 31.81 )
    41.7 ( 26.11 )
    24.1 ( 29.00 )
    28.8 ( 25.92 )
    34.8 ( 34.52 )
    42.6 ( 33.45 )
    28.3 ( 20.86 )
    36.7 ( 25.82 )
    22.9 ( 21.71 )
        Pain, CFB to EoT
    0.0 ( 16.67 )
    -16.7 ( 47.14 )
    -12.5 ( 15.96 )
    -25.0 ( 50.00 )
    20.0 ( 36.13 )
    -16.7 ( 23.57 )
    -5.6 ( 8.61 )
    12.5 ( 30.54 )
    -8.3 ( 11.79 )
    25.0 ( 31.91 )
    -4.2 ( 43.83 )
    8.3 ( 16.67 )
        Dyspnoea, Baseline (Day 1)
    33.3 ( 35.14 )
    11.1 ( 19.25 )
    13.3 ( 17.21 )
    12.5 ( 17.25 )
    22.2 ( 25.95 )
    11.1 ( 16.67 )
    15.2 ( 17.41 )
    33.3 ( 36.51 )
    14.8 ( 24.22 )
    16.7 ( 17.57 )
    16.7 ( 17.57 )
    8.3 ( 15.43 )
        Dyspnoea, CFB to EoT
    33.3 ( 33.33 )
    -16.7 ( 23.57 )
    25.0 ( 31.91 )
    16.7 ( 19.25 )
    0.0 ( 23.57 )
    0.0 ( 0.00 )
    -5.6 ( 13.61 )
    12.5 ( 39.59 )
    16.7 ( 23.57 )
    0.0 ( 0.00 )
    16.7 ( 19.25 )
    0.0 ( 0.00 )
        Insomnia, Baseline (Day 1)
    40.0 ( 26.29 )
    44.4 ( 38.49 )
    33.3 ( 27.22 )
    29.2 ( 21.36 )
    36.1 ( 33.21 )
    25.9 ( 14.70 )
    27.3 ( 25.03 )
    33.3 ( 33.33 )
    37.0 ( 38.89 )
    33.3 ( 31.43 )
    30.0 ( 33.15 )
    8.3 ( 15.43 )
        Insomnia, CFB to EoT
    0.0 ( 33.33 )
    0.0 ( 47.14 )
    -16.7 ( 19.25 )
    0.0 ( 27.22 )
    -6.7 ( 27.89 )
    -16.7 ( 23.57 )
    5.6 ( 25.09 )
    8.3 ( 23.57 )
    0.0 ( 47.14 )
    -16.7 ( 19.25 )
    0.0 ( 54.43 )
    0.0 ( 0.00 )
        AL, Baseline (Day 1)
    23.3 ( 27.44 )
    0.0 ( 0.00 )
    6.7 ( 14.05 )
    25.0 ( 23.57 )
    13.9 ( 22.29 )
    7.4 ( 14.70 )
    12.1 ( 16.82 )
    9.1 ( 15.57 )
    22.2 ( 23.57 )
    26.7 ( 26.29 )
    6.7 ( 14.05 )
    12.5 ( 24.80 )
        AL, CFB to EoT
    22.2 ( 19.25 )
    16.7 ( 23.57 )
    16.7 ( 19.25 )
    -16.7 ( 19.25 )
    0.0 ( 33.33 )
    16.7 ( 23.57 )
    0.0 ( 0.00 )
    -4.2 ( 21.36 )
    0.0 ( 0.00 )
    -8.3 ( 41.94 )
    25.0 ( 50.00 )
    -8.3 ( 16.67 )
        Constipation, Baseline (Day 1)
    20.0 ( 28.11 )
    0.0 ( 0.00 )
    6.7 ( 14.05 )
    12.5 ( 17.25 )
    16.7 ( 26.59 )
    11.1 ( 16.67 )
    12.1 ( 16.82 )
    9.1 ( 15.57 )
    7.4 ( 22.22 )
    13.3 ( 17.21 )
    20.0 ( 32.20 )
    8.3 ( 15.43 )
        Constipation, CFB to EoT
    0.0 ( 0.00 )
    16.7 ( 23.57 )
    16.7 ( 33.33 )
    16.7 ( 33.33 )
    0.0 ( 0.00 )
    0.0 ( 47.14 )
    0.0 ( 0.00 )
    4.2 ( 21.36 )
    0.0 ( 0.00 )
    0.0 ( 0.00 )
    -25.0 ( 31.91 )
    16.7 ( 19.25 )
        Diarrhoea, Baseline (Day 1)
    6.7 ( 14.05 )
    0.0 ( 0.00 )
    16.7 ( 23.57 )
    8.3 ( 15.43 )
    19.4 ( 22.29 )
    11.1 ( 16.67 )
    9.1 ( 15.57 )
    21.2 ( 34.23 )
    11.1 ( 33.33 )
    6.7 ( 21.08 )
    6.7 ( 14.05 )
    12.5 ( 17.25 )
        Diarrhoea, CFB to EoT
    22.2 ( 19.25 )
    33.3 ( 47.14 )
    8.3 ( 31.91 )
    8.3 ( 16.67 )
    -13.3 ( 29.81 )
    -16.7 ( 23.57 )
    -5.6 ( 13.61 )
    0.0 ( 30.86 )
    0.0 ( 0.00 )
    0.0 ( 27.22 )
    16.7 ( 19.25 )
    -8.3 ( 31.91 )
        FD, Baseline (Day 1)
    30.0 ( 33.15 )
    11.1 ( 19.25 )
    30.0 ( 36.68 )
    0.0 ( 0.00 )
    36.1 ( 30.01 )
    7.4 ( 14.70 )
    24.2 ( 36.79 )
    15.2 ( 17.41 )
    25.9 ( 27.78 )
    26.7 ( 37.84 )
    20.0 ( 35.83 )
    20.8 ( 35.36 )
        FD, CFB to EoT
    33.3 ( 57.74 )
    0.0 ( 0.00 )
    8.3 ( 31.91 )
    0.0 ( 0.00 )
    -13.3 ( 18.26 )
    0.0 ( 0.00 )
    0.0 ( 0.00 )
    4.2 ( 21.36 )
    0.0 ( 0.00 )
    16.7 ( 19.25 )
    8.3 ( 16.67 )
    -16.7 ( 33.33 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score - All treated population

    		 Close Top of page
    End point title
    		 Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score - All treated population
    End point description
    The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and up to approximately 4.5 years
    End point values
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Number of subjects analysed
    10
    3
    10
    9
    12
    9
    11
    9
    9
    10
    10
    8
    Units: Score on scale
    arithmetic mean (standard deviation)
        DS, Baseline (Day 1)
    45.0 ( 25.45 )
    24.1 ( 22.45 )
    26.6 ( 12.22 )
    24.7 ( 19.47 )
    40.7 ( 19.58 )
    21.0 ( 19.40 )
    21.2 ( 17.88 )
    31.5 ( 21.15 )
    29.0 ( 23.37 )
    26.7 ( 15.89 )
    25.6 ( 20.15 )
    18.8 ( 8.88 )
        DS, CFB to EoT
    -14.8 ( 17.86 )
    -8.3 ( 27.50 )
    10.0 ( 9.34 )
    -5.6 ( 36.00 )
    23.3 ( 26.76 )
    -2.8 ( 19.64 )
    -8.3 ( 10.39 )
    5.6 ( 22.22 )
    5.6 ( 15.71 )
    -2.8 ( 18.43 )
    12.5 ( 20.48 )
    4.2 ( 13.13 )
        SET, Baseline (Day 1)
    27.5 ( 16.65 )
    21.0 ( 18.64 )
    19.9 ( 11.20 )
    18.8 ( 13.87 )
    23.6 ( 13.79 )
    7.7 ( 6.87 )
    12.7 ( 9.65 )
    15.1 ( 9.43 )
    14.9 ( 6.21 )
    16.7 ( 14.21 )
    13.9 ( 13.60 )
    11.3 ( 8.99 )
        SET, CFB to EoT
    -11.4 ( 15.19 )
    -14.8 ( 15.71 )
    0.1 ( 7.86 )
    0.0 ( 9.07 )
    0.0 ( 14.60 )
    1.9 ( 7.86 )
    3.3 ( 5.00 )
    19.0 ( 19.38 )
    1.1 ( 6.81 )
    -2.7 ( 8.74 )
    5.6 ( 8.74 )
    6.5 ( 20.14 )
        BI, Baseline (Day 1)
    83.3 ( 17.57 )
    100.0 ( 0.00 )
    76.7 ( 31.62 )
    81.5 ( 24.22 )
    77.8 ( 29.59 )
    85.2 ( 24.22 )
    69.7 ( 37.87 )
    88.9 ( 16.67 )
    77.8 ( 33.33 )
    90.0 ( 22.50 )
    93.3 ( 14.05 )
    75.0 ( 34.50 )
        BI, CFB to EoT
    -11.1 ( 50.92 )
    -16.7 ( 23.57 )
    -8.3 ( 31.91 )
    8.3 ( 41.94 )
    6.7 ( 14.91 )
    0.0 ( 0.00 )
    0.0 ( 0.00 )
    -9.5 ( 16.27 )
    0.0 ( 0.00 )
    -8.3 ( 16.67 )
    -8.3 ( 16.67 )
    16.7 ( 19.25 )
        FP, Baseline (Day 1)
    58.9 ( 29.65 )
    48.1 ( 12.83 )
    58.9 ( 28.71 )
    72.8 ( 16.77 )
    65.7 ( 17.38 )
    67.9 ( 17.07 )
    55.6 ( 31.03 )
    59.3 ( 23.57 )
    58.0 ( 34.15 )
    62.2 ( 15.00 )
    63.3 ( 16.60 )
    66.7 ( 13.28 )
        FP, CFB to EoT
    -7.4 ( 51.32 )
    38.9 ( 39.28 )
    16.7 ( 19.25 )
    13.9 ( 13.98 )
    -6.7 ( 21.66 )
    0.0 ( 15.71 )
    1.9 ( 14.77 )
    -3.2 ( 22.87 )
    -5.6 ( 7.86 )
    -8.3 ( 31.91 )
    -2.8 ( 44.79 )
    22.2 ( 15.71 )
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 4.5 years.
    Adverse event reporting additional description
    All treated population included all participants who received at least one dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex
    Reporting group description
    		 Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

    Reporting group title
    Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Reporting group title
    Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Reporting group description
    		 Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

    Serious adverse events
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 12 (50.00%)
    2 / 4 (50.00%)
    8 / 12 (66.67%)
    10 / 16 (62.50%)
    6 / 13 (46.15%)
    8 / 12 (66.67%)
    6 / 12 (50.00%)
    6 / 12 (50.00%)
    7 / 13 (53.85%)
    6 / 12 (50.00%)
    13 / 18 (72.22%)
    9 / 16 (56.25%)
         number of deaths (all causes)
    3
    2
    4
    8
    6
    2
    5
    4
    5
    6
    8
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bowen’s disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Platelet count decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autonomic neuropathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    3 / 12 (25.00%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    1 / 3
    1 / 5
    3 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    2 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter colitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis cryptococcal
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypomagnesaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Belantamab mafodotin 1.9mg/kg STRETCH + Len/Dex Belantamab mafodotin 1.9mg/kg SINGLE + Len/Dex Belantamab mafodotin 1.9 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5mg/kg SINGLE + Len/Dex Belantamab mafodotin 2.5mg/kg SPLIT + Len/Dex Belantamab mafodotin 1.9 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 2.5 mg/kg STRETCH + Bor/Dex Belantamab mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex Belantamab mafodotin 2.5 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 3.4 mg/kg SPLIT + Bor/Dex Belantamab mafodotin 2.5 mg/kg SINGLE + Bor/Dex Belantamab mafodotin 3.4 mg/kg SINGLE + Bor/Dex
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    4 / 4 (100.00%)
    12 / 12 (100.00%)
    16 / 16 (100.00%)
    13 / 13 (100.00%)
    12 / 12 (100.00%)
    12 / 12 (100.00%)
    12 / 12 (100.00%)
    13 / 13 (100.00%)
    12 / 12 (100.00%)
    18 / 18 (100.00%)
    16 / 16 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoma benign
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin cancer
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Plasmacytoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lentigo maligna
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Malignant melanoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Embolism venous
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    Hot flush
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    4 / 18 (22.22%)
    2 / 16 (12.50%)
         occurrences all number
    1
    0
    1
    3
    1
    2
    2
    2
    0
    2
    5
    2
    Phlebitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hypotension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    1
    1
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    5
    1
    0
    0
    0
    3
    0
    0
    0
    Catheter site bruise
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Catheter site pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    3 / 12 (25.00%)
    7 / 16 (43.75%)
    4 / 13 (30.77%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    4 / 12 (33.33%)
    4 / 13 (30.77%)
    5 / 12 (41.67%)
    6 / 18 (33.33%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    3
    10
    5
    6
    5
    5
    5
    5
    6
    3
    Facial pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Face oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Disease progression
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Crepitations
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Chills
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    6
    0
    Chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    1
    0
    Injection site erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    1
    Injection site bruising
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    4
    0
    1
    0
    1
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Feeling abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    1
    0
    0
    1
    1
    0
    Localised oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    5 / 12 (41.67%)
    4 / 12 (33.33%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    3 / 18 (16.67%)
    5 / 16 (31.25%)
         occurrences all number
    2
    1
    0
    6
    1
    2
    5
    5
    2
    0
    5
    5
    Oedema
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    2 / 12 (16.67%)
    2 / 18 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    0
    3
    1
    4
    0
    2
    2
    2
    2
    3
    Soft tissue inflammation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    0
    2
    Testicular swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Genital lesion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    4 / 13 (30.77%)
    2 / 12 (16.67%)
    3 / 18 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    1
    3
    1
    3
    0
    1
    4
    2
    4
    0
    Dyspnoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    4 / 16 (25.00%)
    1 / 13 (7.69%)
    4 / 12 (33.33%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    3 / 12 (25.00%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    0
    4
    1
    5
    3
    0
    2
    3
    2
    2
    Epistaxis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    3
    1
    2
    0
    3
    0
    3
    1
    3
    1
    Haemoptysis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Hiccups
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    2
    Hypoxia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    1
    5
    1
    Productive cough
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    4
    1
    Pneumothorax
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pleuritic pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    1
    0
    1
    1
    0
    Sinus congestion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Anxiety
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Agitation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    1
    1
    4
    1
    0
    0
    1
    1
    2
    2
    Delirium
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Mood altered
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Mental status changes
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    Insomnia
         subjects affected / exposed
    5 / 12 (41.67%)
    2 / 4 (50.00%)
    2 / 12 (16.67%)
    6 / 16 (37.50%)
    1 / 13 (7.69%)
    6 / 12 (50.00%)
    4 / 12 (33.33%)
    3 / 12 (25.00%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    6 / 18 (33.33%)
    4 / 16 (25.00%)
         occurrences all number
    6
    4
    2
    7
    2
    6
    4
    3
    3
    1
    6
    4
    Depression
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    2
    0
    Depressed mood
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nightmare
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    4 / 16 (25.00%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    3 / 12 (25.00%)
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    1
    6
    2
    5
    5
    2
    2
    1
    1
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    2 / 12 (16.67%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    4 / 12 (33.33%)
    5 / 12 (41.67%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    2
    2
    2
    7
    6
    5
    2
    1
    2
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    4
    0
    3
    3
    1
    0
    1
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Electrocardiogram T wave abnormal
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    1
    0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    2
    0
    0
    1
    Blood uric acid decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    4
    1
    0
    2
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    1
    1
    0
    0
    3
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    1
    3
    3
    0
    1
    1
    Lipids increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Intraocular pressure increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    2
    1
    1
    0
    1
    Grip strength decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    3 / 16 (18.75%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    6 / 12 (50.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    2
    4
    0
    2
    6
    1
    1
    1
    0
    2
    Liver function test abnormal
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    5 / 12 (41.67%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    5
    0
    0
    0
    0
    Occult blood positive
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    4 / 12 (33.33%)
    1 / 4 (25.00%)
    2 / 12 (16.67%)
    5 / 16 (31.25%)
    4 / 13 (30.77%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    5
    2
    17
    14
    9
    2
    2
    4
    2
    0
    5
    4
    Platelet count decreased
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 4 (25.00%)
    6 / 12 (50.00%)
    4 / 16 (25.00%)
    5 / 13 (38.46%)
    9 / 12 (75.00%)
    7 / 12 (58.33%)
    7 / 12 (58.33%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    9 / 18 (50.00%)
    5 / 16 (31.25%)
         occurrences all number
    3
    1
    13
    6
    7
    12
    12
    12
    1
    3
    11
    7
    Urine output decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Troponin T increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Staphylococcus test positive
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Visual acuity tests abnormal
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    0
    0
    1
    0
    25
    13
    Weight decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    1
    1
    1
    0
    0
    1
    1
    2
    0
    Weight increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    2
    3
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    White blood cells urine positive
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bone contusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    Chemical burns of eye
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    4 / 18 (22.22%)
    2 / 16 (12.50%)
         occurrences all number
    1
    1
    0
    5
    1
    1
    1
    2
    2
    1
    5
    2
    Corneal abrasion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Joint dislocation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    1
    0
    1
    1
    1
    2
    0
    Infusion related reaction
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    3
    0
    2
    2
    1
    1
    4
    1
    1
    Eye injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Overdose
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Periorbital haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    Tendon rupture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Toxicity to various agents
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Wrist fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    Muir-Torre syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Aortic valve disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    2
    0
    0
    0
    1
    0
    0
    Atrial flutter
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Extrasystoles
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Diastolic dysfunction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Cardiac failure
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Mitral valve disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    1
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Autonomic neuropathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Aphasia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Anosmia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Amnesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Ageusia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Balance disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Burning sensation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    4 / 12 (33.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    6
    0
    1
    2
    0
    1
    3
    1
    1
    2
    4
    2
    Dysaesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    Headache
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 4 (25.00%)
    3 / 12 (25.00%)
    5 / 16 (31.25%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    4 / 12 (33.33%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    2
    1
    3
    5
    0
    2
    4
    2
    1
    1
    2
    3
    Hypoaesthesia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    Lethargy
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    1
    1
    1
    1
    0
    1
    2
    1
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    1
    0
    1
    1
    2
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    3 / 16 (18.75%)
    0 / 13 (0.00%)
    3 / 12 (25.00%)
    3 / 12 (25.00%)
    2 / 12 (16.67%)
    3 / 13 (23.08%)
    3 / 12 (25.00%)
    6 / 18 (33.33%)
    8 / 16 (50.00%)
         occurrences all number
    0
    1
    1
    3
    0
    3
    5
    2
    5
    5
    8
    10
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    2
    1
    1
    0
    1
    0
    0
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 4 (25.00%)
    2 / 12 (16.67%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    4 / 18 (22.22%)
    4 / 16 (25.00%)
         occurrences all number
    1
    1
    2
    3
    1
    4
    2
    2
    1
    3
    6
    5
    Sensory loss
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Radiculopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Presyncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Tremor
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    5 / 16 (31.25%)
    4 / 13 (30.77%)
    3 / 12 (25.00%)
    3 / 12 (25.00%)
    2 / 12 (16.67%)
    3 / 13 (23.08%)
    2 / 12 (16.67%)
    4 / 18 (22.22%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    1
    5
    5
    6
    3
    2
    3
    2
    5
    2
    Leukocytosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 4 (50.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    3 / 13 (23.08%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    2 / 12 (16.67%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    0
    3
    0
    3
    18
    7
    0
    0
    3
    2
    10
    1
    Neutrophilia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 4 (25.00%)
    4 / 12 (33.33%)
    7 / 16 (43.75%)
    2 / 13 (15.38%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    3 / 12 (25.00%)
    9 / 13 (69.23%)
    9 / 12 (75.00%)
    6 / 18 (33.33%)
    9 / 16 (56.25%)
         occurrences all number
    1
    1
    8
    7
    8
    6
    9
    10
    13
    10
    18
    12
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Ear haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hypoacusis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    External ear pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tinnitus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Vertigo
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blepharospasm
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blepharitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    0
    2
    0
    1
    2
    0
    3
    2
    8
    6
    Asthenopia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    Age-related macular degeneration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Chalazion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    3
    3
    Cataract subcapsular
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    1
    Cataract nuclear
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    8
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    2
    Cataract cortical
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    Cataract
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    4
    5
    1
    4
    2
    0
    0
    2
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    1
    0
    1
    0
    1
    0
    Blindness unilateral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    2
    Diplopia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    2
    0
    0
    0
    0
    1
    0
    Corneal opacity
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    Corneal oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Corneal epithelium defect
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cornea verticillata
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Dry eye
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    4 / 18 (22.22%)
    4 / 16 (25.00%)
         occurrences all number
    4
    2
    0
    2
    0
    2
    5
    0
    2
    0
    9
    7
    Foreign body sensation in eyes
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    3
    0
    0
    2
    6
    0
    2
    0
    2
    0
    1
    2
    Glaucoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    Eye pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    0
    2
    0
    0
    0
    Eye pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    4 / 18 (22.22%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    0
    6
    1
    3
    2
    0
    4
    2
    10
    4
    Eye irritation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    2
    Erythema of eyelid
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Keratitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Night blindness
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    Ocular discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    Keratopathy
         subjects affected / exposed
    9 / 12 (75.00%)
    3 / 4 (75.00%)
    9 / 12 (75.00%)
    11 / 16 (68.75%)
    12 / 13 (92.31%)
    11 / 12 (91.67%)
    12 / 12 (100.00%)
    12 / 12 (100.00%)
    10 / 13 (76.92%)
    10 / 12 (83.33%)
    15 / 18 (83.33%)
    15 / 16 (93.75%)
         occurrences all number
    114
    52
    61
    224
    122
    111
    85
    123
    97
    130
    188
    143
    Lacrimation increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Meibomian gland dysfunction
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    0
    0
    0
    2
    0
    0
    2
    0
    5
    6
    Photophobia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    4 / 13 (30.77%)
    1 / 12 (8.33%)
    6 / 18 (33.33%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    0
    4
    1
    2
    0
    9
    2
    12
    2
    Posterior capsule opacification
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Periorbital swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Pterygium
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Punctate keratitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    3 / 18 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    6 / 16 (37.50%)
    7 / 13 (53.85%)
    3 / 12 (25.00%)
    5 / 12 (41.67%)
    5 / 12 (41.67%)
    5 / 13 (38.46%)
    3 / 12 (25.00%)
    12 / 18 (66.67%)
    7 / 16 (43.75%)
         occurrences all number
    0
    2
    2
    27
    12
    7
    9
    10
    17
    6
    56
    24
    Uveitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    5 / 12 (41.67%)
    1 / 4 (25.00%)
    4 / 12 (33.33%)
    5 / 16 (31.25%)
    4 / 13 (30.77%)
    6 / 12 (50.00%)
    4 / 12 (33.33%)
    4 / 12 (33.33%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    2 / 18 (11.11%)
    3 / 16 (18.75%)
         occurrences all number
    26
    23
    26
    77
    29
    39
    24
    49
    2
    39
    2
    7
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Vitreous detachment
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    4
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    2
    0
    1
    1
    1
    Abdominal pain
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 4 (50.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    2 / 13 (15.38%)
    2 / 12 (16.67%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    2
    2
    0
    1
    1
    2
    0
    3
    5
    3
    0
    2
    Anal fistula
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Aerophagia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    1
    1
    Anal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 4 (50.00%)
    3 / 12 (25.00%)
    3 / 16 (18.75%)
    3 / 13 (23.08%)
    8 / 12 (66.67%)
    2 / 12 (16.67%)
    5 / 12 (41.67%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    6 / 18 (33.33%)
    7 / 16 (43.75%)
         occurrences all number
    3
    2
    3
    3
    3
    8
    2
    7
    4
    0
    6
    8
    Colitis microscopic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Anal incontinence
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Dental caries
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Diverticulum
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    5 / 12 (41.67%)
    3 / 4 (75.00%)
    6 / 12 (50.00%)
    6 / 16 (37.50%)
    6 / 13 (46.15%)
    5 / 12 (41.67%)
    0 / 12 (0.00%)
    6 / 12 (50.00%)
    4 / 13 (30.77%)
    1 / 12 (8.33%)
    8 / 18 (44.44%)
    4 / 16 (25.00%)
         occurrences all number
    9
    6
    13
    11
    9
    6
    0
    11
    6
    1
    12
    9
    Dysphagia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    Dyspepsia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    4
    1
    Dry mouth
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    2
    2
    Flatulence
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    3 / 16 (18.75%)
         occurrences all number
    2
    0
    2
    0
    1
    1
    0
    0
    2
    1
    1
    3
    Gingival bleeding
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Glossodynia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gingival swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hyperaesthesia teeth
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Lip swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Loose tooth
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    1
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 4 (50.00%)
    4 / 12 (33.33%)
    3 / 16 (18.75%)
    4 / 13 (30.77%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    5 / 12 (41.67%)
    3 / 13 (23.08%)
    2 / 12 (16.67%)
    8 / 18 (44.44%)
    7 / 16 (43.75%)
         occurrences all number
    2
    2
    4
    4
    5
    2
    1
    5
    5
    2
    18
    10
    Oral discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Paraesthesia oral
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    3
    0
    Tooth loss
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    3 / 18 (16.67%)
    5 / 16 (31.25%)
         occurrences all number
    0
    0
    2
    2
    4
    2
    1
    2
    4
    0
    4
    5
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Actinic keratosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Blister
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cold sweat
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Blood blister
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cold urticaria
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Petechiae
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    3
    0
    0
    0
    1
    1
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    0
    1
    0
    3
    1
    1
    1
    0
    1
    0
    3
    2
    Rash
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    3
    2
    0
    0
    1
    2
    0
    2
    1
    5
    0
    1
    Purpura
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Skin disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Skin plaque
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    1
    Dysuria
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    1
    1
    2
    1
    Urinary hesitation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Urinary retention
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Incontinence
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    Hyperparathyroidism secondary
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Thyroid mass
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    3 / 16 (18.75%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    4 / 13 (30.77%)
    1 / 12 (8.33%)
    3 / 18 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    2
    5
    3
    1
    2
    0
    5
    1
    3
    2
    Arthritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    4
    2
    0
    0
    0
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 4 (25.00%)
    2 / 12 (16.67%)
    1 / 16 (6.25%)
    3 / 13 (23.08%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    3 / 13 (23.08%)
    0 / 12 (0.00%)
    5 / 18 (27.78%)
    3 / 16 (18.75%)
         occurrences all number
    2
    1
    3
    1
    3
    2
    2
    3
    3
    0
    5
    3
    Bone cyst
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Bone pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    2 / 12 (16.67%)
    2 / 16 (12.50%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    3 / 13 (23.08%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    2
    2
    1
    0
    0
    2
    3
    1
    1
    2
    Flank pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Exposed bone in jaw
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Diffuse idiopathic skeletal hyperostosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Costochondritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Chest wall haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Bursitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    2
    0
    Groin pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    Muscle spasms
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    4 / 16 (25.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    8
    4
    0
    1
    0
    0
    3
    0
    1
    Muscle atrophy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Limb discomfort
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Kyphosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    0
    2
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    0
    3
    1
    1
    0
    2
    0
    1
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Osteonecrosis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    3 / 13 (23.08%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    2
    0
    1
    2
    3
    1
    1
    0
    3
    0
    2
    2
    Pain in jaw
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tendon disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    Tendon pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Campylobacter infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Campylobacter colitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    COVID-19
         subjects affected / exposed
    3 / 12 (25.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    3 / 16 (18.75%)
    2 / 13 (15.38%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    4 / 12 (33.33%)
    2 / 13 (15.38%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    0
    3
    2
    3
    0
    4
    3
    1
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Cystitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Device related infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    Enterovirus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Epididymitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Eye infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    0
    0
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    0
    0
    1
    0
    1
    0
    Kidney infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    Hordeolum
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    2
    Herpes simplex reactivation
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Herpes ophthalmic
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nosocomial infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    2
    1
    0
    1
    0
    0
    1
    0
    0
    Nail infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 4 (25.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    0
    1
    0
    2
    4
    2
    Oral candidiasis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    1
    1
    1
    0
    0
    Lip infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Periodontitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Picornavirus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    1
    0
    1
    1
    1
    1
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Prostate infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    2
    0
    0
    1
    0
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    Rhinovirus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    2
    0
    1
    1
    Sepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Tinea pedis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 4 (25.00%)
    1 / 12 (8.33%)
    3 / 16 (18.75%)
    2 / 13 (15.38%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    3 / 12 (25.00%)
    9 / 18 (50.00%)
    6 / 16 (37.50%)
         occurrences all number
    2
    1
    1
    4
    4
    2
    0
    2
    2
    4
    11
    6
    Urinary tract infection
         subjects affected / exposed
    4 / 12 (33.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    8
    0
    0
    2
    0
    1
    1
    1
    1
    0
    2
    3
    Urinary tract infection viral
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    2 / 18 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    Metabolism and nutrition disorders
    Appetite disorder
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    3 / 16 (18.75%)
    1 / 13 (7.69%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    5 / 18 (27.78%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    1
    3
    1
    3
    0
    0
    0
    1
    7
    3
    Dehydration
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Diabetes mellitus
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Fluid retention
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Folate deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Gout
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    2
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    2 / 16 (12.50%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    1 / 18 (5.56%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    2
    2
    0
    1
    2
    0
    1
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    4 / 16 (25.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    4
    0
    2
    0
    0
    1
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    2 / 16 (12.50%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    2 / 18 (11.11%)
    4 / 16 (25.00%)
         occurrences all number
    0
    0
    0
    4
    0
    1
    0
    0
    1
    0
    4
    6
    Hypophosphataemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    1 / 16 (6.25%)
    0 / 13 (0.00%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 13 (15.38%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    1
    0
    2
    0
    1
    6
    0
    0
    1
    Iron deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 4 (0.00%)
    1 / 12 (8.33%)
    4 / 16 (25.00%)
    1 / 13 (7.69%)
    2 / 12 (16.67%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    3 / 18 (16.67%)
    2 / 16 (12.50%)
         occurrences all number
    1
    0
    1
    4
    1
    4
    0
    2
    1
    0
    3
    3
    Hypoglycaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Magnesium deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Steroid diabetes
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 13 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 13 (7.69%)
    0 / 12 (0.00%)
    0 / 18 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2018
    Protocol Amendment 1 include following: • additional authors who contributed to protocol amendment were added • change in the Primary Medical Monitor • Changes made in the Schedule of Activities tables. The SOA tables have been modified to reflect that the disease assessments need to be performed at regular intervals instead of being linked to the administration of study drugs. Revisions have also been made in the timings and frequency of some assessments. • Minor correction made in the participants’ eligibility criteria; participants with prior allogenic SCT will now be excluded (Section 6). • Clarification made on dose delays of study drugs by giving examples of different scenarios (Section 7.2). • All routine and disease evaluation related blood and urine tests now will be done locally; centrally only if unable to perform locally (Table 16) • Administrative changes made throughout the document.
    26 Apr 2019
    Protocol Amendment 3 included following changes: i) Protocol was amended to change ECOG eligibility criteria in Arm A from 0-2 to 0-1 ii) to include additional guidance for management of neutropenia / prophylaxis of infections to be implemented across the study on resuming Arm A and iii) more stringent hematological monitoring for both Arm A and Arm B. Administration of belantamab mafodotin divided as two equal administrations a week apart will also be evaluated to see if this dosing schedule would result in improvement of benefit/risk due to ~25% reduction in the maximum concentration while maintaining similar exposure over a cycle compared to the full administration on Day 1. Protocol Amendment 2 also incorporates the Protocol Clarification letter previously issued to study sites, that provided updated guidance on grading corneal events and dosing participants with belantamab mafodotin. Administrative corrections and general program updates are also included in Amendment 2.
    13 Jul 2020
    Protocol Amendment 3 included following changes: i) Updated duration of contraception for female participants to align with this guidance of child bearing potential based on review of guidelines on aneugens. ii) Changes to ophthalmologic assessments based on these findings. iii) Reduced dose levels and extended dosing schedules for belantamab mafodotin will be evaluated in Amendment 3. • Arm A (Belantamab mafodotin + Len/Dex; 28-day cycle): A potential extended dosing schedule has been introduced via this amendment, where belantamab mafodotin at 1.9 mg/kg will be administered once every 8 weeks (STRETCH) and will be evaluated dependent on emerging data. The cycle duration will remain 28 days/4 weeks. Up to 12 participants will be enrolled in this new cohort. • Arm B (Belantamab mafodotin + Bor/Dex; 21-day cycle): 4 new dosing cohorts (2.5 mg/kg STRETCH, 2.5 → 1.9 mg/kg S/D STRETCH, 1.9 mg/kg SINGLE (Q3W dosing) and 1.9 mg/kg STRETCH) are being added. Up to 12 participants will be enrolled in each of these 4 new cohorts.

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

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

    European Medicines Agency © 1995-Sun May 11 06:47:26 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA