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    Clinical Trial Results:
    A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors

    Summary
    EudraCT number
    		 2017-001553-14
    Trial protocol
    		 GB  
    Global end of trial date
    04 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2024
    First version publication date
    11 May 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BGB-290-103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03150810
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BeiGene
    Sponsor organisation address
    1840 Gateway Drive, Third Floor, San Mateo , United States, 94404
    Public contact
    Clinical Trial Information Email, BeiGene USA, Inc., 01 877-828-5568, clinicaltrials@beigene.com
    Scientific contact
    Clinical Trial Information Email, BeiGene USA, Inc., 01 877-828-5568, clinicaltrials@beigene.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with temozolomide (TMZ), to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.
    Protection of trial subjects
    This trial was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of GCP as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki. The IEC/IRB-approved ICF was signed and dated by the subject or the subject’s legally authorized representative before his or her participation in the study. A copy of each signed ICF was provided to the subject or the subject’s legally authorized representative. All signed and dated ICFs were retained in each patient’s study file or in the site file. For any updated or revised ICFs, written informed consent was obtained using the IEC/IRB-approved updated/revised ICFs for continued participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Spain: 43
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    United States: 74
    Worldwide total number of subjects
    139
    EEA total number of subjects
    43
    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)
    78
    From 65 to 84 years
    60
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled in multiple study centers in Australia, Europe, and North America.

    Pre-assignment
    Screening details
    		 The study was composed of an initial screening phase (up to 28 days), a treatment phase, a safety follow-up phase (including Safety Follow-up Visit), and a survival follow-up phase.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None (open-label)

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams
    Arm description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
    Arm description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
    Arm description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
    Arm description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
    Arm description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
    Arm description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Arm description
    		 Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
    Arm description
    		 Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ at various doses administered by mouth as a capsule once daily.

    Arm title
    		 Dose Expansion: Gastric Cancer
    Arm description
    		 Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ 60 mg administered by mouth as a capsule once daily.

    Arm title
    		 Dose Expansion: Ovarian Cancer
    Arm description
    		 Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ 60 mg administered by mouth as a capsule once daily.

    Arm title
    		 Dose Expansion: SCLC
    Arm description
    		 Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ 60 mg administered by mouth as a capsule once daily.

    Arm title
    		 Dose Expansion: TNBC
    Arm description
    		 Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ 60 mg administered by mouth as a capsule once daily.

    Arm title
    		 Dose Expansion: Other HRD+ Cancers
    Arm description
    		 Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pamiparib
    Investigational medicinal product code
    Other name
    BGB-290
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Pamiparib 60 mg administered by mouth as a capsule twice daily

    Investigational medicinal product name
    Temozolomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    TMZ 60 mg administered by mouth as a capsule once daily.

    Number of subjects in period 1
    		Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Started
    4
    13
    9
    3
    3
    14
    14
    6
    21
    4
    22
    1
    25
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    4
    13
    9
    3
    3
    14
    14
    6
    21
    4
    22
    1
    25
         Consent withdrawn by subject
    -
    1
    1
    1
    -
    -
    2
    -
    2
    -
    1
    -
    1
         Physician decision
    -
    -
    -
    -
    -
    1
    1
    -
    -
    -
    -
    -
    -
         Hospice
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Death
    4
    8
    7
    2
    2
    10
    8
    6
    18
    3
    19
    1
    19
         Sponsor Decision
    -
    2
    -
    -
    1
    1
    -
    -
    1
    -
    -
    -
    5
         Site withdrawal from study
    -
    1
    -
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
         Lost to follow-up
    -
    1
    1
    -
    -
    -
    1
    -
    -
    -
    1
    -
    -
         Participant relocated abroad
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Transferred care to oncologist
    -
    -
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Reporting group description
    		 Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
    Reporting group description
    		 Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

    Reporting group title
    Dose Expansion: Gastric Cancer
    Reporting group description
    		 Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: Ovarian Cancer
    Reporting group description
    		 Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: SCLC
    Reporting group description
    		 Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: TNBC
    Reporting group description
    		 Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: Other HRD+ Cancers
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers Total
    Number of subjects
    		 4 13 9 3 3 14 14 6 21 4 22 1 25 139
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 8 0 2 1 5 5 3 13 4 13 1 21 78
        From 65-84 years
    		 2 5 8 1 2 9 9 3 8 0 9 0 4 60
        85 years and over
    		 0 0 1 0 0 0 0 0 0 0 0 0 0 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.5 ( 6.19 ) 58.0 ( 10.52 ) 72.3 ( 6.22 ) 60.3 ( 10.69 ) 65.7 ( 13.80 ) 66.7 ( 10.21 ) 66.9 ( 9.96 ) 66.7 ( 8.31 ) 58.8 ( 14.68 ) 59.3 ( 2.22 ) 61.9 ( 8.33 ) 31.0 ( 9999 ) 58.1 ( 8.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 7 5 2 1 6 7 2 8 4 8 1 10 64
        Male
    		 1 6 4 1 2 8 7 4 13 0 14 0 15 75
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 0 0 0 0 0 1 0 0 0 1 0 0 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 1 0 0 0 0 1
        Black or African American
    		 0 1 0 1 2 3 1 1 1 0 0 0 0 10
        White
    		 4 10 9 2 1 7 8 5 18 2 18 1 20 105
        Unknown or Not Reported
    		 0 2 0 0 0 3 5 0 1 1 4 0 5 21

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Reporting group description
    		 Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
    Reporting group description
    		 Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

    Reporting group title
    Dose Expansion: Gastric Cancer
    Reporting group description
    		 Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: Ovarian Cancer
    Reporting group description
    		 Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: SCLC
    Reporting group description
    		 Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: TNBC
    Reporting group description
    		 Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: Other HRD+ Cancers
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Subject analysis set title
    Pamiparib 60 mg BID
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.

    Primary: Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

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    End point title
    		 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) [1] [2]
    End point description
    A DLT is defined as one of the following toxicities occurring during the DLT assessment window: Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting >7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting > 3 days and requiring transfusion, or any decreased platelet count <15,000/mm3/ <15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or AST) The dose-escalation safety analysis set comprised all dose-escalation phase participants who received pamiparib and/or TMZ.
    End point type
    Primary
    End point timeframe
    From first dose of study drug(s) to 28 days post-dose (up to approximately 1 year and 6 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis available for descriptive data
    [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: No statistical analysis available for descriptive data
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Number of subjects analysed
    4
    13
    9
    3
    3
    14
    14
    Units: Number of Participants
    0
    0
    0
    2
    2
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Adverse Events (AEs)

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    End point title
    		 Number of Participants Experiencing Adverse Events (AEs) [3]
    End point description
    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03 The Safety Analysis Set included all participants who received any dose of pamiparib and/or TMZ.
    End point type
    Primary
    End point timeframe
    From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
    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: No statistical analysis available for descriptive data
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Number of subjects analysed
    4
    13
    9
    3
    3
    14
    14
    6
    21
    4
    22
    1
    25
    Units: Number of Participants
        Participants With At Least 1 TEAE
    4
    13
    9
    3
    3
    14
    14
    6
    20
    4
    22
    1
    24
        Participants with Serious TEAEs
    1
    4
    1
    2
    2
    5
    5
    0
    9
    3
    9
    0
    9
    No statistical analyses for this end point

    Primary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR) [4]
    End point description
    ORR is defined as the percentage of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where BOR is defined as the best response recorded from the first postbaseline tumor assessment until data cutoff date, disease progression or start of new anticancer treatment. The Efficacy Analysis Set included all participants who were in the safety analysis set, had measurable disease at baseline and had at least one postbaseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment.
    End point type
    Primary
    End point timeframe
    Up to approximately 5 years and 10 months
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis available for descriptive data
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Number of subjects analysed
    3
    12
    8
    2
    2
    14
    13
    4
    19
    4
    20
    1
    25
    Units: Percentage of Participants
        number (confidence interval 90%)
    0.0 (0.0 to 63.2)
    16.7 (3.0 to 43.8)
    25.0 (4.6 to 60.0)
    0.0 (0.0 to 77.6)
    0.0 (0.0 to 77.6)
    21.4 (6.1 to 46.6)
    0.0 (0.0 to 20.6)
    25.0 (1.3 to 75.1)
    0.0 (0.0 to 14.6)
    50.0 (9.8 to 90.2)
    15.0 (4.2 to 34.4)
    100.0 (5.0 to 100.0)
    8.0 (1.4 to 23.1)
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Pamiparib

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    1945.31 ( 25 )
    No statistical analyses for this end point

    Secondary: Steady State Maximum Observed Plasma Concentration (Cmax) of Pamiparib

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    End point title
    		 Steady State Maximum Observed Plasma Concentration (Cmax) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    3796.08 ( 33 )
    No statistical analyses for this end point

    Secondary: Steady State Lowest Concentration Reached Before the Next Dose Administered (Ctrough) of Pamiparib

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    End point title
    		 Steady State Lowest Concentration Reached Before the Next Dose Administered (Ctrough) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    2335.6 ( 76 )
    No statistical analyses for this end point

    Secondary: Time to Reach Cmax (Tmax) of Pamiparib

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    End point title
    		 Time to Reach Cmax (Tmax) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: Hours
        median (full range (min-max))
    1.83 (0.83 to 2.17)
    No statistical analyses for this end point

    Secondary: Terminal Elimination Half-life (t1/2) of Pamiparib

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    End point title
    		 Terminal Elimination Half-life (t1/2) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: Hours
        geometric mean (full range (min-max))
    11.825 (5.94 to 33.58)
    No statistical analyses for this end point

    Secondary: Apparent Clearance (CL/F) of Pamiparib

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    End point title
    		 Apparent Clearance (CL/F) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: L/h
        geometric mean (geometric coefficient of variation)
    38.14 ( 15 )
    No statistical analyses for this end point

    Secondary: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Pamiparib

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    End point title
    		 Apparent Volume of Distribution During Terminal Phase (Vz/F) of Pamiparib
    End point description
    Pharmacokinetic (PK) Analysis Set included all participants who received any dose of pamiparib and contributed at least one plasma concentration.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15 of 28-day cycle
    End point values
    		 Pamiparib 60 mg BID
    Number of subjects analysed
    20
    Units: Liters
        geometric mean (geometric coefficient of variation)
    38.14 ( 15 )
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR)

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    End point title
    		 Disease Control Rate (DCR)
    End point description
    DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) based on investigator assessment using RECIST v1.1; The Efficacy Analysis Set included all participants who were in the safety analysis set, had measurable disease at baseline and had at least one postbaseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years and 10 months
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Number of subjects analysed
    3
    12
    8
    2
    2
    14
    13
    4
    19
    4
    20
    1
    25
    Units: Percentage of Participants
        number (confidence interval 90%)
    33.3 (1.7 to 86.5)
    91.7 (66.1 to 99.6)
    75.0 (40.0 to 95.4)
    100.0 (22.4 to 100.0)
    50.0 (2.5 to 97.5)
    42.9 (20.6 to 67.5)
    53.8 (28.7 to 77.6)
    75.0 (24.9 to 98.7)
    42.1 (23.0 to 63.2)
    75.0 (24.9 to 98.7)
    75.0 (54.4 to 89.6)
    100.0 (5.0 to 100.0)
    52.0 (34.1 to 69.5)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to disease progression or death due to any cause, whichever occurs earlier, based on investigator assessment using RECIST v1.1. Only responders will be included in the assessment. The Efficacy Analysis Set included all participants who were in the safety analysis set, had measurable disease at baseline and had at least one postbaseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years and 10 months
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Number of subjects analysed
    0 [5]
    2 [6]
    2 [7]
    0 [8]
    0 [9]
    3 [10]
    0 [11]
    1 [12]
    0 [13]
    2 [14]
    3 [15]
    1 [16]
    2 [17]
    Units: months
        median (confidence interval 90%)
    ( to )
    13.0 (0000 to 9999)
    6.4 (5.5 to 9999)
    ( to )
    ( to )
    9.2 (7.7 to 9999)
    ( to )
    3.7 (0000 to 9999)
    ( to )
    5.4 (4.9 to 9999)
    3.8 (3.2 to 9999)
    11.0 (0000 to 9999)
    9999 (7.4 to 9999)
    Notes
    [5] - NA = Not estimable due to insufficient number of participants with events
    [6] - 0000/9999- Not estimable due to insufficient number of participants with events
    [7] - 9999- Not estimable due to insufficient number of participants with events
    [8] - Not estimable due to insufficient number of participants with events
    [9] - Not estimable due to insufficient number of participants with events
    [10] - 9999- Not estimable due to insufficient number of participants with events
    [11] - Not estimable due to insufficient number of participants with events
    [12] - 0000/9999- Not estimable due to insufficient number of participants with events
    [13] - Not estimable due to insufficient number of participants with events
    [14] - 9999- Not estimable due to insufficient number of participants with events
    [15] - 9999- Not estimable due to insufficient number of participants with events
    [16] - 0000/9999- Not estimable due to insufficient number of participants with events
    [17] - 9999- Not estimable due to insufficient number of participants with events
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as the time (months) from the date of the first dose of combination treatment to disease progression or death due to any cause, whichever occurs first, based on investigator assessment using RECIST v1.1
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years and 10 months
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Number of subjects analysed
    3 [18]
    12
    8
    2
    2
    14
    13
    4
    19
    4
    20
    1 [19]
    25
    Units: Months
        median (confidence interval 90%)
    2.0 (1.2 to 9999)
    5.6 (2.7 to 22.0)
    5.3 (1.8 to 7.5)
    9999 (4.5 to 9999)
    9999 (1.8 to 9999)
    2.8 (1.7 to 3.7)
    3.1 (1.7 to 3.9)
    3.5 (1.1 to 9999)
    1.9 (1.7 to 3.3)
    6.4 (2.6 to 9999)
    3.5 (2.3 to 4.1)
    14.8 (0000 to 9999)
    2.6 (1.9 to 3.6)
    Notes
    [18] - 9999 = Not estimable due to insufficient number of participants with events
    [19] - 0000/9999 = Not estimable due to insufficient number of participants with events
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from the date of the first dose of combination treatment to death due to any cause; The Safety Analysis Set included all participants who received any dose of pamiparib and/or TMZ.
    End point type
    Secondary
    End point timeframe
    Up to approximately 5 years and 10 months
    End point values
    		 Dose Escalation: Pamiparib + temozolomide (TMZ) 40 milligrams Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Expansion: Other HRD+ Cancers
    Number of subjects analysed
    4 [20]
    13
    9
    3
    3
    14
    14
    6
    21
    4
    22
    1
    25 [21]
    Units: Months
        median (confidence interval 90%)
    7.6 (2.2 to 9999)
    14.8 (8.4 to 9999)
    12.7 (9.4 to 9999)
    12.4 (4.5 to 9999)
    12.3 (4.2 to 9999)
    6.3 (3.4 to 31.8)
    13.9 (8.0 to 9999)
    8.2 (1.1 to 12.7)
    6.6 (3.8 to 9.9)
    21.2 (11.1 to 9999)
    7.7 (4.1 to 13.1)
    19.4 (0000 to 9999)
    9.8 (7.6 to 11.7)
    Notes
    [20] - 9999 = Not estimable due to insufficient number of participants with events
    [21] - 0000/9999 = Not estimable due to insufficient number of participants with events
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
    Adverse event reporting additional description
    All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
    Reporting group description
    		 Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle

    Reporting group title
    Dose Expansion: Other HRD+ Cancers
    Reporting group description
    		 Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
    Reporting group description
    		 Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

    Reporting group title
    Dose Expansion: Gastric Cancer
    Reporting group description
    		 Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: Ovarian Cancer
    Reporting group description
    		 Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: SCLC
    Reporting group description
    		 Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Expansion: TNBC
    Reporting group description
    		 Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle

    Reporting group title
    Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Reporting group description
    		 Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle

    Serious adverse events
    		 Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1- Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Expansion: Other HRD+ Cancers Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 13 (30.77%)
    1 / 9 (11.11%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    5 / 14 (35.71%)
    9 / 25 (36.00%)
    0 / 6 (0.00%)
    9 / 21 (42.86%)
    3 / 4 (75.00%)
    9 / 22 (40.91%)
    0 / 1 (0.00%)
    5 / 14 (35.71%)
         number of deaths (all causes)
    4
    8
    7
    2
    2
    10
    19
    6
    18
    3
    19
    1
    8
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Vascular disorders
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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 / 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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         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
    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
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Injury, poisoning and procedural complications
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         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
    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
    0 / 0
    Congenital, familial and genetic disorders
    Right-to-left cardiac shunt
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         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 / 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
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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 / 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
    0 / 0
    Precerebral artery embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    2 / 2
    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
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    1 / 1
    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
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    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
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    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
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Gastric perforation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    0 / 0
         deaths 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
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    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
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         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 / 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
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Pneumocystis jirovecii infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    0 / 14 (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 / 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
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         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
    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
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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 / 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
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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
    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
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (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 / 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
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1- Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7) Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14) Dose Expansion: Other HRD+ Cancers Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28) Dose Expansion: Gastric Cancer Dose Expansion: Ovarian Cancer Dose Expansion: SCLC Dose Expansion: TNBC Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    13 / 13 (100.00%)
    9 / 9 (100.00%)
    3 / 3 (100.00%)
    3 / 3 (100.00%)
    14 / 14 (100.00%)
    24 / 25 (96.00%)
    6 / 6 (100.00%)
    20 / 21 (95.24%)
    4 / 4 (100.00%)
    22 / 22 (100.00%)
    1 / 1 (100.00%)
    14 / 14 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Malignant ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Infected neoplasm
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Cancer pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Vascular disorders
    Capillary fragility
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Peripheral venous disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    5 / 25 (20.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    7
    0
    2
    1
    2
    0
    0
    Axillary pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    Chills
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Early satiety
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 4 (50.00%)
    9 / 13 (69.23%)
    5 / 9 (55.56%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    10 / 14 (71.43%)
    7 / 25 (28.00%)
    2 / 6 (33.33%)
    12 / 21 (57.14%)
    3 / 4 (75.00%)
    13 / 22 (59.09%)
    0 / 1 (0.00%)
    4 / 14 (28.57%)
         occurrences all number
    2
    10
    5
    2
    1
    10
    9
    2
    13
    3
    19
    0
    6
    Gait disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    2 / 9 (22.22%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    2
    1
    0
    3
    0
    1
    0
    0
    1
    0
    0
    Sluggishness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    4 / 14 (28.57%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    2 / 4 (50.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    0
    1
    5
    1
    0
    2
    2
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular device occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Nipple pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Aphonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    2 / 4 (50.00%)
    2 / 13 (15.38%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    4 / 25 (16.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    5 / 22 (22.73%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    2
    2
    2
    1
    0
    3
    6
    0
    1
    1
    6
    0
    2
    Dysphonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 13 (23.08%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    3 / 25 (12.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    1
    3
    1
    4
    0
    2
    3
    1
    1
    0
    2
    0
    2
    Hiccups
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    0
    Increased bronchial secretion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hypoxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Increased upper airway secretion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    0
    Pleural effusion
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Wheezing
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 13 (23.08%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    2 / 25 (8.00%)
    2 / 6 (33.33%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    2
    2
    2
    1
    1
    1
    0
    0
    Hallucination
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    2 / 6 (33.33%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    2 / 25 (8.00%)
    2 / 6 (33.33%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    1
    0
    0
    3
    2
    2
    3
    0
    1
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    2 / 9 (22.22%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    2 / 25 (8.00%)
    1 / 6 (16.67%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    3
    2
    1
    4
    0
    0
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    5 / 25 (20.00%)
    1 / 6 (16.67%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    3
    5
    1
    2
    0
    0
    0
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    2 / 9 (22.22%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    8 / 25 (32.00%)
    2 / 6 (33.33%)
    4 / 21 (19.05%)
    0 / 4 (0.00%)
    7 / 22 (31.82%)
    0 / 1 (0.00%)
    3 / 14 (21.43%)
         occurrences all number
    0
    2
    2
    1
    0
    2
    15
    2
    5
    0
    11
    0
    4
    Platelet count decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    3 / 9 (33.33%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    8 / 25 (32.00%)
    2 / 6 (33.33%)
    5 / 21 (23.81%)
    1 / 4 (25.00%)
    9 / 22 (40.91%)
    1 / 1 (100.00%)
    3 / 14 (21.43%)
         occurrences all number
    1
    0
    5
    1
    0
    2
    8
    2
    5
    1
    14
    6
    7
    Weight decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    2 / 9 (22.22%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    0
    2
    2
    1
    0
    2
    0
    2
    0
    0
    1
    2
    White blood cell count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    3 / 9 (33.33%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    2 / 25 (8.00%)
    2 / 6 (33.33%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    4 / 22 (18.18%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    1
    3
    0
    0
    1
    2
    2
    1
    0
    4
    0
    3
    Injury, poisoning and procedural complications
    Compression fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fibula fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Radius fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Aortic valve disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Areflexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Aphasia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cognitive disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    4 / 14 (28.57%)
         occurrences all number
    1
    1
    1
    1
    0
    3
    0
    0
    2
    2
    1
    0
    4
    Dizziness postural
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 13 (30.77%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    4 / 22 (18.18%)
    1 / 1 (100.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    4
    0
    0
    0
    3
    2
    0
    0
    3
    6
    1
    2
    Dysgeusia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    2
    1
    0
    1
    1
    1
    0
    0
    Dysarthria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hemiparesis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Multiple sclerosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mental impairment
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Paraparesis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Parosmia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    3
    0
    0
    Taste disorder
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    8 / 13 (61.54%)
    5 / 9 (55.56%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    10 / 14 (71.43%)
    16 / 25 (64.00%)
    3 / 6 (50.00%)
    12 / 21 (57.14%)
    2 / 4 (50.00%)
    13 / 22 (59.09%)
    1 / 1 (100.00%)
    6 / 14 (42.86%)
         occurrences all number
    0
    11
    8
    8
    4
    15
    25
    4
    15
    4
    18
    4
    10
    Lymphadenopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 4 (25.00%)
    5 / 13 (38.46%)
    4 / 9 (44.44%)
    1 / 3 (33.33%)
    3 / 3 (100.00%)
    7 / 14 (50.00%)
    3 / 25 (12.00%)
    2 / 6 (33.33%)
    6 / 21 (28.57%)
    2 / 4 (50.00%)
    6 / 22 (27.27%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    3
    10
    5
    6
    9
    15
    4
    2
    6
    5
    12
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 13 (30.77%)
    3 / 9 (33.33%)
    2 / 3 (66.67%)
    3 / 3 (100.00%)
    5 / 14 (35.71%)
    5 / 25 (20.00%)
    1 / 6 (16.67%)
    5 / 21 (23.81%)
    3 / 4 (75.00%)
    6 / 22 (27.27%)
    1 / 1 (100.00%)
    3 / 14 (21.43%)
         occurrences all number
    1
    8
    5
    8
    4
    16
    6
    1
    6
    3
    7
    5
    4
    Thrombocytosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Ear pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Glaucoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cataract
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Iridocyclitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    2 / 9 (22.22%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    2 / 14 (14.29%)
    3 / 25 (12.00%)
    1 / 6 (16.67%)
    3 / 21 (14.29%)
    1 / 4 (25.00%)
    2 / 22 (9.09%)
    1 / 1 (100.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    0
    1
    2
    3
    1
    3
    1
    2
    1
    1
    Abdominal distension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    3 / 21 (14.29%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    2 / 25 (8.00%)
    2 / 6 (33.33%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    2
    1
    0
    0
    0
    0
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Anorectal discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Anal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    4 / 25 (16.00%)
    1 / 6 (16.67%)
    5 / 21 (23.81%)
    2 / 4 (50.00%)
    6 / 22 (27.27%)
    0 / 1 (0.00%)
    6 / 14 (42.86%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    8
    1
    6
    2
    6
    0
    6
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 13 (23.08%)
    3 / 9 (33.33%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    4 / 14 (28.57%)
    3 / 25 (12.00%)
    2 / 6 (33.33%)
    5 / 21 (23.81%)
    2 / 4 (50.00%)
    3 / 22 (13.64%)
    1 / 1 (100.00%)
    3 / 14 (21.43%)
         occurrences all number
    0
    5
    4
    1
    1
    4
    4
    2
    9
    4
    6
    1
    3
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    3 / 22 (13.64%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    4
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    1
    0
    1
    0
    1
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    2
    1
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 4 (75.00%)
    9 / 13 (69.23%)
    5 / 9 (55.56%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    5 / 14 (35.71%)
    7 / 25 (28.00%)
    4 / 6 (66.67%)
    12 / 21 (57.14%)
    4 / 4 (100.00%)
    12 / 22 (54.55%)
    1 / 1 (100.00%)
    6 / 14 (42.86%)
         occurrences all number
    3
    12
    5
    2
    2
    6
    10
    4
    14
    4
    20
    1
    8
    Oral pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Oesophageal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Saliva altered
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Small intestinal perforation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    2 / 4 (50.00%)
    3 / 22 (13.64%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    0
    0
    2
    3
    0
    0
    Tongue pigmentation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
    5 / 13 (38.46%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    4 / 14 (28.57%)
    4 / 25 (16.00%)
    1 / 6 (16.67%)
    10 / 21 (47.62%)
    2 / 4 (50.00%)
    7 / 22 (31.82%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    2
    5
    1
    1
    2
    10
    4
    1
    15
    2
    12
    0
    2
    Hepatobiliary disorders
    Gallbladder obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail discolouration
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Onychoclasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    1 / 1 (100.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    Xanthoma
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal colic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urethral stenosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 13 (30.77%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    2 / 14 (14.29%)
    1 / 25 (4.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    3 / 22 (13.64%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    4
    0
    1
    2
    2
    1
    2
    1
    1
    4
    0
    1
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    2 / 3 (66.67%)
    0 / 14 (0.00%)
    4 / 25 (16.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    1 / 4 (25.00%)
    5 / 22 (22.73%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    0
    3
    0
    4
    1
    1
    1
    5
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    1
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 13 (23.08%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    3 / 14 (21.43%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    4
    1
    1
    1
    3
    1
    0
    1
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    2
    0
    0
    0
    2
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Muscle tightness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 13 (15.38%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Osteopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    1
    0
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    1
    0
    0
    0
    1
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Groin abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Groin infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Infected bite
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Onychomycosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    1 / 1 (100.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    1
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    2 / 25 (8.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    2 / 4 (50.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    2
    0
    1
    3
    0
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    2 / 22 (9.09%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    1
    0
    1
    0
    2
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
    6 / 13 (46.15%)
    2 / 9 (22.22%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    4 / 14 (28.57%)
    4 / 25 (16.00%)
    1 / 6 (16.67%)
    8 / 21 (38.10%)
    3 / 4 (75.00%)
    11 / 22 (50.00%)
    0 / 1 (0.00%)
    5 / 14 (35.71%)
         occurrences all number
    1
    6
    2
    1
    0
    4
    5
    1
    8
    3
    12
    0
    8
    Dehydration
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 13 (23.08%)
    1 / 9 (11.11%)
    1 / 3 (33.33%)
    0 / 3 (0.00%)
    5 / 14 (35.71%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    1
    3
    1
    1
    0
    5
    0
    0
    0
    0
    0
    0
    2
    Gout
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 25 (4.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    3 / 14 (21.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    6
    Hypernatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    2 / 21 (9.52%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    1 / 4 (25.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    1 / 3 (33.33%)
    1 / 3 (33.33%)
    4 / 14 (28.57%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    1 / 22 (4.55%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    0
    2
    2
    6
    0
    0
    1
    0
    1
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    Hypophosphataemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 13 (0.00%)
    1 / 9 (11.11%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    1 / 6 (16.67%)
    1 / 21 (4.76%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    2 / 14 (14.29%)
         occurrences all number
    1
    0
    2
    0
    0
    3
    0
    1
    1
    0
    0
    0
    3
    Vitamin D deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 13 (0.00%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 13 (7.69%)
    0 / 9 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 25 (0.00%)
    0 / 6 (0.00%)
    0 / 21 (0.00%)
    0 / 4 (0.00%)
    0 / 22 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2017
    Version 1.0
    15 Dec 2017
    Protocol Amendment 1.1 (UK)
    25 Feb 2020
    Protocol Amendment 2.0
    19 Jun 2020
    Protocol Amendment 3.0

    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.

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