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    Clinical Trial Results:
    CheckpOiNt blockade For Inhibition of Relapsed Mesothelioma (CONFIRM): A Phase III Trial to Evaluate the Efficacy of Nivolumab in Relapsed Mesothelioma

    Summary
    EudraCT number
    		 2016-003111-35
    Trial protocol
    		 GB  
    Global end of trial date
    16 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2023
    First version publication date
    01 Mar 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    22864
    Additional study identifiers
    ISRCTN number
    		 ISRCTN79814141
    US NCT number
    		 NCT03063450
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Southampton
    Sponsor organisation address
    University Road, Southampton, United Kingdom, SO17 1BJ
    Public contact
    Calley Middleton, University of Southampton , 44 02381205608, C.Middleton@soton.ac.uk
    Scientific contact
    Calley Middleton, University of Southampton , 44 02381205608, C.Middleton@soton.ac.uk
    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
    09 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This trial aims to determine whether nivolumab increases overall survival in patients with relapsed mesothelioma.
    Protection of trial subjects
    Nivolumab is safe and well tolerated up to 10 mg/kg Q2W dose level. Adverse events have been broadly consistent across tumour types following monotherapy and have not demonstrated clear dose-response or exposure-response relationships. Additionally, the simulated median and 95th prediction interval of nivolumab summary exposures across body weight range (35 - 160 kg) are predicted to be maintained below the corresponding observed highest exposure experienced in nivolumab. Thus, while subjects in the lower body weight ranges would have greater exposures than 80 kg subjects, the exposures are predicted to be within the range of observed exposures at doses (up to 10 mg/kg Q2W) used in the nivolumab clinical program, and are not considered to put subjects at increased risk. Trial participants were frequently monitored for adverse events, and participants and their treating clinicians are able to withdraw treatment as desired.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 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
    United Kingdom: 332
    Worldwide total number of subjects
    332
    EEA total number of subjects
    0
    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)
    81
    From 65 to 84 years
    251
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients underwent screening evaluations (e.g., medical history, physical exam, CT scan), within 28 days prior to first trial treatment, to determine eligibility. Concomitant medications were assessed within 14 days. Pregnancy tests were completed for women of child-bearing potential at screening, within 24 hours prior to start of treatment.

    Period 1
    Period 1 title
    Final analysis (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Treatment allocation was achieved through use of an online randomisation system. Blinding was achieved by ensuring only pharmacy staff were aware of participant allocation, and through the use of placebo (matched on volume and delivery).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nivolumab
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    240mg over 30 minutes every 14 days (+/-2 days). The infusion was to be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 μm.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    240mg over 30 minutes every 14 days (+/-2 days). The infusion was to be administered through a sterile, non-pyrogenic, low protein binding in-line filter with a pore size of 0.2-1.2 μm.

    Number of subjects in period 1
    		Nivolumab Placebo
    Started
    221
    111
    Completed
    13
    5
    Not completed
    208
    106
         Consent withdrawn by subject
    7
    4
         Physician decision
    8
    3
         Disease progression
    142
    85
         Adverse event, non-fatal
    30
    3
         Other
    21
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nivolumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Nivolumab Placebo Total
    Number of subjects
    		 221 111 332
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 70 (65 to 74) 71 (65 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 54 25 79
        Male
    		 167 86 253
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analysed as randomised

    Subject analysis sets values
    		 ITT
    Number of subjects
    332
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    70 (65 to 75)
    Gender categorical
    Units: Subjects
        Female
    79
        Male
    253

    End points

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    End points reporting groups
    Reporting group title
    Nivolumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Analysed as randomised

    Primary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Primary
    End point timeframe
    From randomisation to at least 6 months after the last participant was recruited
    End point values
    		 Nivolumab Placebo ITT
    Number of subjects analysed
    221
    111
    332
    Units: Months
        median (confidence interval 95%)
    9.5 (7.7 to 11.0)
    6.8 (5.0 to 7.9)
    8.0 (7.2 to 9.5)
    Statistical analysis title
    		 OS analysis
    Comparison groups
    Nivolumab v Placebo v ITT
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.096
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.58

    Primary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Primary
    End point timeframe
    From randomisation until at least 6 months after last participant is recruited
    End point values
    		 Nivolumab Placebo ITT
    Number of subjects analysed
    221
    111
    332
    Units: Months
        median (confidence interval 95%)
    2.9 (2.8 to 4.1)
    1.6 (1.4 to 2.6)
    2.8 (2.7 to 2.9)
    Statistical analysis title
    		 PFS
    Comparison groups
    Nivolumab v Placebo v ITT
    Number of subjects included in analysis
    664
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Nivolumab
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Nivolumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    88 / 221 (39.82%)
    48 / 111 (43.24%)
         number of deaths (all causes)
    198
    100
         number of deaths resulting from adverse events
    5
    6
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous Cell Carcinoma Of Lung
    Additional description: Squamous Cell Carcinoma Of Lung
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Neoplasm
    Additional description: Bladder Neoplasm
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma Malignant
    Additional description: Mesothelioma Malignant
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mesothelioma
    Additional description: Mesothelioma
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
    Additional description: Deep Vein Thrombosis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominal Cavity Drainage
    Additional description: Abdominal Cavity Drainage
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain Management
    Additional description: Pain Management
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pain
    Additional description: Pain
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 111 (1.80%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
    Additional description: Oedema Peripheral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
    Additional description: General Physical Health Deterioration
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease Progression
    Additional description: Disease Progression
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 111 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Chest Pain
    Additional description: Chest Pain
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
    Additional description: Prostatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
    Additional description: Pneumonitis
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Obstruction Unspecified
    Additional description: Respiratory Obstruction Unspecified
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
    Additional description: Pleural Effusion
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
    Additional description: Pneumonia Aspiration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
    Additional description: Pulmonary Embolism
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    18 / 221 (8.14%)
    9 / 111 (8.11%)
         occurrences causally related to treatment / all
    4 / 20
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Painful Respiration
    Additional description: Painful Respiration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
    Additional description: Pulmonary Oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional State
    Additional description: Confusional State
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood Bilirubin Increased
    Additional description: Blood Bilirubin Increased
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-Glutamyltransferase Increased
    Additional description: Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine Aminotransferase Increased
    Additional description: Alanine Aminotransferase Increased
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases
    Additional description: Transaminases
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate Aminotransferase Increased
    Additional description: Aspartate Aminotransferase Increased
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Alkaline Phosphatase Increased
    Additional description: Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
    Additional description: Blood Creatinine Increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen Saturation Decreased
    Additional description: Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
    Additional description: Fall
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
    Additional description: Toxicity To Various Agents
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
    Additional description: Femoral Neck Fracture
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
    Additional description: Hip Fracture
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion Related Reaction
    Additional description: Infusion Related Reaction
         subjects affected / exposed
    4 / 221 (1.81%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular Block
    Additional description: Atrioventricular Block
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
    Additional description: Pericardial Effusion
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Supraventricular Tachycardia
    Additional description: Supraventricular Tachycardia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Coronary Syndrome
    Additional description: Acute Coronary Syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Tachycardia
    Additional description: Sinus Tachycardia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Hypoperfusion
    Additional description: Cerebral Hypoperfusion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paralysis
    Additional description: Facial Paralysis
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
    Additional description: Ataxia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
    Additional description: Cerebral Haemorrhage
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
    Additional description: Cerebrovascular Accident
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal Cord Compression
    Additional description: Spinal Cord Compression
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 111 (1.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diplopia
    Additional description: Diplopia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmoplegia
    Additional description: Ophthalmoplegia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 111 (1.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Microscopic
    Additional description: Colitis Microscopic
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    5 / 221 (2.26%)
    5 / 111 (4.50%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
    Additional description: Ileus
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
    Additional description: Ascites
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
    Additional description: Intestinal Obstruction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
    Additional description: Abdominal Pain
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune Hepatitis
    Additional description: Autoimmune Hepatitis
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
    Additional description: Acute Kidney Injury
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
    Additional description: Myositis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
    Additional description: Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
    Additional description: Back Pain
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pilonidal Cyst
    Additional description: Pilonidal Cyst
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
    Additional description: Herpes Zoster
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19
    Additional description: Covid-19
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
    Additional description: Respiratory Tract Infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    13 / 221 (5.88%)
    6 / 111 (5.41%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
    Additional description: Lower Respiratory Tract Infection
         subjects affected / exposed
    8 / 221 (3.62%)
    7 / 111 (6.31%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Sepsis
    Additional description: Neutropenic Sepsis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    Additional description: Infection
         subjects affected / exposed
    3 / 221 (1.36%)
    3 / 111 (2.70%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 111 (1.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
    Additional description: Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Nivolumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    204 / 221 (92.31%)
    97 / 111 (87.39%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
    Additional description: Cancer pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Vascular disorders
    Phlebitis
    Additional description: Phlebitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Peripheral coldness
    Additional description: Peripheral coldness
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Brachiocephalic vein thrombosis
    Additional description: Brachiocephalic vein thrombosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Embolism
    Additional description: Embolism
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    9 / 221 (4.07%)
    1 / 111 (0.90%)
         occurrences all number
    9
    1
    Raynaud's phenomenon
    Additional description: Raynaud's phenomenon
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Angiopathy
    Additional description: Angiopathy
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Superior vena cava occlusion
    Additional description: Superior vena cava occlusion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Ischaemia
    Additional description: Ischaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    5 / 221 (2.26%)
    4 / 111 (3.60%)
         occurrences all number
    7
    5
    General disorders and administration site conditions
    Catheter site rash
    Additional description: Catheter site rash
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    11 / 221 (4.98%)
    2 / 111 (1.80%)
         occurrences all number
    12
    2
    Catheter site hypersensitivity
    Additional description: Catheter site hypersensitivity
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    11 / 221 (4.98%)
    4 / 111 (3.60%)
         occurrences all number
    11
    5
    Hyperthermia
    Additional description: Hyperthermia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Swelling
    Additional description: Swelling
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    3
    1
    Adverse reaction
    Additional description: Adverse reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Catheter site erythema
    Additional description: Catheter site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Effusion
    Additional description: Effusion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    17 / 221 (7.69%)
    8 / 111 (7.21%)
         occurrences all number
    21
    11
    Catheter site pruritus
    Additional description: Catheter site pruritus
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Adverse drug reaction
    Additional description: Adverse drug reaction
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences all number
    6
    0
    Mass
    Additional description: Mass
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Chills
    Additional description: Chills
         subjects affected / exposed
    5 / 221 (2.26%)
    0 / 111 (0.00%)
         occurrences all number
    5
    0
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Generalised oedema
    Additional description: Generalised oedema
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
    Additional description: Chest discomfort
         subjects affected / exposed
    4 / 221 (1.81%)
    2 / 111 (1.80%)
         occurrences all number
    4
    2
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    7 / 221 (3.17%)
    4 / 111 (3.60%)
         occurrences all number
    7
    4
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    18 / 221 (8.14%)
    8 / 111 (7.21%)
         occurrences all number
    18
    9
    Facial pain
    Additional description: Facial pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Catheter site phlebitis
    Additional description: Catheter site phlebitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Cyst
    Additional description: Cyst
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Pain
    Additional description: Pain
         subjects affected / exposed
    21 / 221 (9.50%)
    5 / 111 (4.50%)
         occurrences all number
    22
    6
    Feeling cold
    Additional description: Feeling cold
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Axillary pain
    Additional description: Axillary pain
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Vaccination site pain
    Additional description: Vaccination site pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Early satiety
    Additional description: Early satiety
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    85 / 221 (38.46%)
    33 / 111 (29.73%)
         occurrences all number
    100
    35
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Infusion site hypoaesthesia
    Additional description: Infusion site hypoaesthesia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Medical device site nodule
    Additional description: Medical device site nodule
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    3 / 221 (1.36%)
    3 / 111 (2.70%)
         occurrences all number
    3
    4
    Immune system disorders
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    2
    2
    Autoimmune disorder
    Additional description: Autoimmune disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Genital rash
    Additional description: Genital rash
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Penile rash
    Additional description: Penile rash
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Breast mass
    Additional description: Breast mass
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Nipple pain
    Additional description: Nipple pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
    Additional description: Bronchial obstruction
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    66 / 221 (29.86%)
    28 / 111 (25.23%)
         occurrences all number
    74
    32
    Dry throat
    Additional description: Dry throat
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Choking
    Additional description: Choking
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Pneumonitis
    Additional description: Pneumonitis
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Productive cough
    Additional description: Productive cough
         subjects affected / exposed
    7 / 221 (3.17%)
    2 / 111 (1.80%)
         occurrences all number
    7
    2
    Wheezing
    Additional description: Wheezing
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Pleuritic pain
    Additional description: Pleuritic pain
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 111 (0.90%)
         occurrences all number
    3
    1
    Nasal congestion
    Additional description: Nasal congestion
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Sputum discoloured
    Additional description: Sputum discoloured
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Increased bronchial secretion
    Additional description: Increased bronchial secretion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 111 (1.80%)
         occurrences all number
    2
    2
    Rhinorrhoea
    Additional description: Rhinorrhoea
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    6 / 221 (2.71%)
    2 / 111 (1.80%)
         occurrences all number
    6
    2
    Stridor
    Additional description: Stridor
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Hypoxia
    Additional description: Hypoxia
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    2
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Cough
    Additional description: Cough
         subjects affected / exposed
    41 / 221 (18.55%)
    21 / 111 (18.92%)
         occurrences all number
    48
    22
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    2 / 221 (0.90%)
    3 / 111 (2.70%)
         occurrences all number
    2
    3
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Increased viscosity of bronchial secretion
    Additional description: Increased viscosity of bronchial secretion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    8 / 221 (3.62%)
    1 / 111 (0.90%)
         occurrences all number
    8
    1
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    5 / 221 (2.26%)
    1 / 111 (0.90%)
         occurrences all number
    5
    1
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
    Additional description: Depression
         subjects affected / exposed
    6 / 221 (2.71%)
    2 / 111 (1.80%)
         occurrences all number
    6
    2
    Abnormal dreams
    Additional description: Abnormal dreams
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    5 / 221 (2.26%)
    1 / 111 (0.90%)
         occurrences all number
    5
    1
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 111 (0.90%)
         occurrences all number
    3
    1
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    12 / 221 (5.43%)
    3 / 111 (2.70%)
         occurrences all number
    12
    3
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    5 / 221 (2.26%)
    2 / 111 (1.80%)
         occurrences all number
    5
    2
    Irritability
    Additional description: Irritability
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Hallucination
    Additional description: Hallucination
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 111 (0.90%)
         occurrences all number
    3
    1
    Investigations
    Haematocrit decreased
    Additional description: Haematocrit decreased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    4 / 221 (1.81%)
    1 / 111 (0.90%)
         occurrences all number
    6
    1
    Thyroxine decreased
    Additional description: Thyroxine decreased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Tri-iodothyronine free increased
    Additional description: Tri-iodothyronine free increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    White blood cell count increased
    Additional description: White blood cell count increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Blood phosphorus decreased
    Additional description: Blood phosphorus decreased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 111 (1.80%)
         occurrences all number
    2
    2
    Blood thyroid stimulating hormone decreased
    Additional description: Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Creatinine renal clearance decreased
    Additional description: Creatinine renal clearance decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Amylase increased
    Additional description: Amylase increased
         subjects affected / exposed
    6 / 221 (2.71%)
    1 / 111 (0.90%)
         occurrences all number
    7
    2
    Lymphocyte count decreased
    Additional description: Lymphocyte count decreased
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences all number
    6
    0
    Tri-iodothyronine increased
    Additional description: Tri-iodothyronine increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    7 / 221 (3.17%)
    0 / 111 (0.00%)
         occurrences all number
    7
    0
    Transaminases increased
    Additional description: Transaminases increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Tri-iodothyronine decreased
    Additional description: Tri-iodothyronine decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count increased
    Additional description: Neutrophil count increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Tri-iodothyronine free decreased
    Additional description: Tri-iodothyronine free decreased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Platelet count increased
    Additional description: Platelet count increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Blood calcium decreased
    Additional description: Blood calcium decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Blood testosterone decreased
    Additional description: Blood testosterone decreased
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    0
    2
    Blood phosphorus increased
    Additional description: Blood phosphorus increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Blood thyroid stimulating hormone increased
    Additional description: Blood thyroid stimulating hormone increased
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences all number
    6
    0
    Thyroxine free increased
    Additional description: Thyroxine free increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    12 / 221 (5.43%)
    9 / 111 (8.11%)
         occurrences all number
    13
    9
    Thyroxine free decreased
    Additional description: Thyroxine free decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    9 / 221 (4.07%)
    1 / 111 (0.90%)
         occurrences all number
    9
    1
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    8 / 221 (3.62%)
    0 / 111 (0.00%)
         occurrences all number
    10
    0
    Blood magnesium decreased
    Additional description: Blood magnesium decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    3 / 221 (1.36%)
    2 / 111 (1.80%)
         occurrences all number
    3
    4
    Blood creatine phosphokinase
    Additional description: Blood creatine phosphokinase
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Protein total decreased
    Additional description: Protein total decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Lipase increased
    Additional description: Lipase increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Radiation skin injury
    Additional description: Radiation skin injury
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Procedural pain
    Additional description: Procedural pain
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Face injury
    Additional description: Face injury
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Thoracic vertebral fracture
    Additional description: Thoracic vertebral fracture
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Fall
    Additional description: Fall
         subjects affected / exposed
    8 / 221 (3.62%)
    2 / 111 (1.80%)
         occurrences all number
    8
    2
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Infusion related reaction
    Additional description: Infusion related reaction
         subjects affected / exposed
    14 / 221 (6.33%)
    0 / 111 (0.00%)
         occurrences all number
    17
    0
    Cardiac disorders
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Cardiac dysfunction
    Additional description: Cardiac dysfunction
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 111 (1.80%)
         occurrences all number
    1
    2
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Peripheral motor neuropathy
    Additional description: Peripheral motor neuropathy
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 111 (0.90%)
         occurrences all number
    3
    1
    Drooling
    Additional description: Drooling
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Lethargy
    Additional description: Lethargy
         subjects affected / exposed
    12 / 221 (5.43%)
    6 / 111 (5.41%)
         occurrences all number
    14
    6
    Headache
    Additional description: Headache
         subjects affected / exposed
    13 / 221 (5.88%)
    4 / 111 (3.60%)
         occurrences all number
    20
    5
    Burning sensation
    Additional description: Burning sensation
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Dizziness postural
    Additional description: Dizziness postural
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Taste disorder
    Additional description: Taste disorder
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    2
    1
    Neuralgia
    Additional description: Neuralgia
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    2
    1
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Peroneal nerve palsy
    Additional description: Peroneal nerve palsy
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    11 / 221 (4.98%)
    2 / 111 (1.80%)
         occurrences all number
    11
    2
    Balance disorder
    Additional description: Balance disorder
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences all number
    4
    0
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    6 / 221 (2.71%)
    1 / 111 (0.90%)
         occurrences all number
    6
    1
    Anosmia
    Additional description: Anosmia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Trigeminal neuralgia
    Additional description: Trigeminal neuralgia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences all number
    4
    0
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Hypersomnia
    Additional description: Hypersomnia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
    Additional description: Dysgeusia
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 111 (1.80%)
         occurrences all number
    1
    2
    Spinal cord compression
    Additional description: Spinal cord compression
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    2
    1
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    22 / 221 (9.95%)
    4 / 111 (3.60%)
         occurrences all number
    29
    5
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Hypoacusis
    Additional description: Hypoacusis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    0
    2
    Cerumen impaction
    Additional description: Cerumen impaction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Eye disorders
    Glare
    Additional description: Glare
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    1 / 221 (0.45%)
    3 / 111 (2.70%)
         occurrences all number
    1
    3
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    4 / 221 (1.81%)
    2 / 111 (1.80%)
         occurrences all number
    4
    2
    Macular oedema
    Additional description: Macular oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    2
    Blepharitis
    Additional description: Blepharitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Eye swelling
    Additional description: Eye swelling
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Eye pruritus
    Additional description: Eye pruritus
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Photopsia
    Additional description: Photopsia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Cystoid macular oedema
    Additional description: Cystoid macular oedema
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Eye irritation
    Additional description: Eye irritation
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Foreign body sensation in eyes
    Additional description: Foreign body sensation in eyes
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Uveitis
    Additional description: Uveitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    60 / 221 (27.15%)
    27 / 111 (24.32%)
         occurrences all number
    69
    29
    Paraesthesia oral
    Additional description: Paraesthesia oral
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Hiatus hernia
    Additional description: Hiatus hernia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Abdominal mass
    Additional description: Abdominal mass
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Abdominal pain lower
    Additional description: Abdominal pain lower
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Glossodynia
    Additional description: Glossodynia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Anal incontinence
    Additional description: Anal incontinence
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    47 / 221 (21.27%)
    23 / 111 (20.72%)
         occurrences all number
    66
    24
    Frequent bowel movements
    Additional description: Frequent bowel movements
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    6 / 221 (2.71%)
    6 / 111 (5.41%)
         occurrences all number
    6
    7
    Tongue ulceration
    Additional description: Tongue ulceration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Proctalgia
    Additional description: Proctalgia
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    41 / 221 (18.55%)
    17 / 111 (15.32%)
         occurrences all number
    66
    29
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
    Additional description: Mouth ulceration
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    2
    1
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    8 / 221 (3.62%)
    8 / 111 (7.21%)
         occurrences all number
    8
    8
    Oral pain
    Additional description: Oral pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    8 / 221 (3.62%)
    1 / 111 (0.90%)
         occurrences all number
    9
    1
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 221 (2.71%)
    0 / 111 (0.00%)
         occurrences all number
    6
    0
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    5 / 221 (2.26%)
    1 / 111 (0.90%)
         occurrences all number
    5
    1
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    3 / 221 (1.36%)
    3 / 111 (2.70%)
         occurrences all number
    3
    3
    Tongue haemorrhage
    Additional description: Tongue haemorrhage
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    6 / 221 (2.71%)
    4 / 111 (3.60%)
         occurrences all number
    6
    4
    Haematemesis
    Additional description: Haematemesis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Lip dry
    Additional description: Lip dry
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    2
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    4 / 221 (1.81%)
    2 / 111 (1.80%)
         occurrences all number
    4
    2
    Hyperaesthesia teeth
    Additional description: Hyperaesthesia teeth
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gingival pain
    Additional description: Gingival pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Melaena
    Additional description: Melaena
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Swollen tongue
    Additional description: Swollen tongue
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Ascites
    Additional description: Ascites
         subjects affected / exposed
    6 / 221 (2.71%)
    2 / 111 (1.80%)
         occurrences all number
    8
    2
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    5 / 221 (2.26%)
    4 / 111 (3.60%)
         occurrences all number
    6
    5
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    25 / 221 (11.31%)
    9 / 111 (8.11%)
         occurrences all number
    28
    10
    Hepatobiliary disorders
    Hepatotoxicity
    Additional description: Hepatotoxicity
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    4 / 221 (1.81%)
    0 / 111 (0.00%)
         occurrences all number
    4
    0
    Rash
    Additional description: Rash
         subjects affected / exposed
    27 / 221 (12.22%)
    4 / 111 (3.60%)
         occurrences all number
    35
    5
    Rash erythematous
    Additional description: Rash erythematous
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    11 / 221 (4.98%)
    4 / 111 (3.60%)
         occurrences all number
    11
    4
    Lichen planus
    Additional description: Lichen planus
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    4
    0
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Night sweats
    Additional description: Night sweats
         subjects affected / exposed
    7 / 221 (3.17%)
    4 / 111 (3.60%)
         occurrences all number
    7
    4
    Decubitus ulcer
    Additional description: Decubitus ulcer
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
    Additional description: Rash pruritic
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Skin disorder
    Additional description: Skin disorder
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Photosensitivity reaction
    Additional description: Photosensitivity reaction
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    3 / 221 (1.36%)
    3 / 111 (2.70%)
         occurrences all number
    3
    3
    Pain of skin
    Additional description: Pain of skin
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    28 / 221 (12.67%)
    11 / 111 (9.91%)
         occurrences all number
    31
    14
    Renal and urinary disorders
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    2
    3
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Chromaturia
    Additional description: Chromaturia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Proteinuria
    Additional description: Proteinuria
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Renal vein thrombosis
    Additional description: Renal vein thrombosis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
    Additional description: Pollakiuria
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Renal impairment
    Additional description: Renal impairment
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Endocrine disorders
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    12 / 221 (5.43%)
    1 / 111 (0.90%)
         occurrences all number
    12
    1
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Flank pain
    Additional description: Flank pain
         subjects affected / exposed
    3 / 221 (1.36%)
    3 / 111 (2.70%)
         occurrences all number
    3
    3
    Pain in jaw
    Additional description: Pain in jaw
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    12 / 221 (5.43%)
    2 / 111 (1.80%)
         occurrences all number
    14
    3
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    9 / 221 (4.07%)
    2 / 111 (1.80%)
         occurrences all number
    9
    2
    Inguinal mass
    Additional description: Inguinal mass
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    4 / 221 (1.81%)
    1 / 111 (0.90%)
         occurrences all number
    4
    1
    Limb discomfort
    Additional description: Limb discomfort
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    5 / 221 (2.26%)
    1 / 111 (0.90%)
         occurrences all number
    5
    1
    Chest wall mass
    Additional description: Chest wall mass
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Joint stiffness
    Additional description: Joint stiffness
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    3 / 221 (1.36%)
    3 / 111 (2.70%)
         occurrences all number
    3
    3
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    31 / 221 (14.03%)
    18 / 111 (16.22%)
         occurrences all number
    38
    21
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 111 (0.90%)
         occurrences all number
    2
    1
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    5 / 221 (2.26%)
    1 / 111 (0.90%)
         occurrences all number
    5
    1
    Tendonitis
    Additional description: Tendonitis
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Arthropathy
    Additional description: Arthropathy
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 111 (0.90%)
         occurrences all number
    3
    1
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    16 / 221 (7.24%)
    9 / 111 (8.11%)
         occurrences all number
    16
    10
    Infections and infestations
    Skin infection
    Additional description: Skin infection
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    COVID-19
    Additional description: COVID-19
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    10 / 221 (4.52%)
    7 / 111 (6.31%)
         occurrences all number
    10
    8
    Staphylococcal infection
    Additional description: Staphylococcal infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Spontaneous bacterial peritonitis
    Additional description: Spontaneous bacterial peritonitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    3 / 221 (1.36%)
    2 / 111 (1.80%)
         occurrences all number
    5
    2
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 111 (0.90%)
         occurrences all number
    1
    1
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    4 / 221 (1.81%)
    2 / 111 (1.80%)
         occurrences all number
    4
    2
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Infection
    Additional description: Infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 111 (1.80%)
         occurrences all number
    2
    2
    Candida infection
    Additional description: Candida infection
         subjects affected / exposed
    6 / 221 (2.71%)
    1 / 111 (0.90%)
         occurrences all number
    6
    1
    Rash pustular
    Additional description: Rash pustular
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    37 / 221 (16.74%)
    12 / 111 (10.81%)
         occurrences all number
    45
    14
    Lymphangitis
    Additional description: Lymphangitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Mucosal infection
    Additional description: Mucosal infection
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 111 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    7 / 221 (3.17%)
    5 / 111 (4.50%)
         occurrences all number
    7
    5
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    8 / 221 (3.62%)
    5 / 111 (4.50%)
         occurrences all number
    8
    5
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    10 / 221 (4.52%)
    4 / 111 (3.60%)
         occurrences all number
    14
    5
    Vulvovaginal candidiasis
    Additional description: Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Eye infection
    Additional description: Eye infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
    Additional description: Gingivitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    4 / 221 (1.81%)
    1 / 111 (0.90%)
         occurrences all number
    4
    1
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Tinea pedis
    Additional description: Tinea pedis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Medical device site infection
    Additional description: Medical device site infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Oesophageal candidiasis
    Additional description: Oesophageal candidiasis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypophosphataemia
    Additional description: Hypophosphataemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 111 (1.80%)
         occurrences all number
    0
    2
    Hypophagia
    Additional description: Hypophagia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    44 / 221 (19.91%)
    26 / 111 (23.42%)
         occurrences all number
    45
    29
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    3 / 221 (1.36%)
    2 / 111 (1.80%)
         occurrences all number
    3
    2
    Hypoalbuminaemia
    Additional description: Hypoalbuminaemia
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    3
    0
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Polydipsia
    Additional description: Polydipsia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    1
    Vitamin D deficiency
    Additional description: Vitamin D deficiency
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 111 (1.80%)
         occurrences all number
    3
    2
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Gout
    Additional description: Gout
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hyperamylasaemia
    Additional description: Hyperamylasaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0
    Hypercalcaemia
    Additional description: Hypercalcaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 111 (0.90%)
         occurrences all number
    0
    2
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    3 / 221 (1.36%)
    0 / 111 (0.00%)
         occurrences all number
    4
    0
    Hypomagnesaemia
    Additional description: Hypomagnesaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 111 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2018
    V3 - Assessment and treatment windows defined; screening and baseline factors differentiated
    26 Apr 2018
    V4 - AEs to be reported from start of treatment rather than consent
    14 Feb 2019
    V6 - addition of progression free survival as co-primary endpoint; inclusion of second line treatment in eligibility criteria.
    11 Jun 2020
    V7 - Addition of +/-3 days for CT scans; nivolumab administration updated to align with new IB; clarification of how co-primary endpoints were to be analysed; removal of interim analyses
    13 Nov 2020
    V8 - updated translational objectives, endpoints and analysis section; updated modified RECIST link

    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.
    COVID-19 pandemic led to early termination of recruitment; however, the study was four participants short of target, and, given the sample size was based on number of events rather than number of people, the study could achieve the intended power.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34656227
    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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