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    Clinical Trial Results:
    A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)

    Summary
    EudraCT number
    		 2010-020150-34
    Trial protocol
    		 DE   NL   ES   SE   CZ   GB   LT   IT   BE   PT  
    Global end of trial date
    23 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2016
    First version publication date
    04 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V212-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01229267
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study to determine whether investigational V212 reduces the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic cell transplants (auto-HCT).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 2010
    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
    Spain: 42
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    United States: 540
    Country: Number of subjects enrolled
    Argentina: 16
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Belgium: 70
    Country: Number of subjects enrolled
    Brazil: 25
    Country: Number of subjects enrolled
    Canada: 21
    Country: Number of subjects enrolled
    Colombia: 34
    Country: Number of subjects enrolled
    Croatia: 10
    Country: Number of subjects enrolled
    Czech Republic: 66
    Country: Number of subjects enrolled
    Ecuador: 3
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    Germany: 100
    Country: Number of subjects enrolled
    Israel: 44
    Country: Number of subjects enrolled
    Italy: 38
    Country: Number of subjects enrolled
    Korea, Republic of: 61
    Country: Number of subjects enrolled
    Lithuania: 20
    Country: Number of subjects enrolled
    Mexico: 12
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    Panama: 10
    Country: Number of subjects enrolled
    Peru: 12
    Country: Number of subjects enrolled
    Portugal: 14
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Russian Federation: 14
    Worldwide total number of subjects
    1230
    EEA total number of subjects
    429
    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)
    982
    From 65 to 84 years
    248
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study enrolled men and women 18 years of age or older who were varicella history positive (or VZV antibody positive) and were scheduled to receive an auto-HCT for treatment of lymphoma or other indication (including any other malignancies) within 60 days of enrollment. Additional inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 A total of 1323 participants were screened and 1257 were randomized. Twenty-seven participants were removed from all analyses due to the identification of major Good Clinical Practice compliance issues at a single site. Thus, a total of 1230 participants were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V212 Consistency Lots (excluding High Antigen Lot)
    Arm description
    		 V212 consistency Lot 1, 2, or 3 (Excluding High Antigen Lot) administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V212
    Investigational medicinal product code
    Other name
    Inactivated Varicella-Zoster (VZV) vaccine Consistency Lot 1, 2, or 3
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5-mL subcutaneous injection alternating deltoid muscles for consecutive vaccinations

    Arm title
    		 V212 High Antigen Lot
    Arm description
    		 V212 High Antigen Lot administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V212
    Investigational medicinal product code
    Other name
    Inactivated Varicella-Zoster (VZV) vaccine High Antigen Lot
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5-mL subcutaneous injection alternating deltoid muscles for consecutive vaccinations

    Arm title
    		 Placebo
    Arm description
    		 Placebo to V212 administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo to V212
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5-mL subcutaneous injection alternating deltoid muscles for consecutive vaccinations

    Number of subjects in period 1
    		V212 Consistency Lots (excluding High Antigen Lot) V212 High Antigen Lot Placebo
    Started
    560
    106
    564
    Received Vaccination 1
    554
    104
    556
    Received Vaccination 2
    502
    94
    511
    Received Vaccination 3
    478
    89
    491
    Received Vaccination 4
    453
    87
    477
    Completed
    311
    71
    344
    Not completed
    249
    35
    220
         Consent withdrawn by subject
    77
    14
    59
         Physician decision
    27
    3
    25
         Adverse event, non-fatal
    13
    2
    10
         Death
    112
    13
    103
         Lost to follow-up
    19
    3
    22
         Progressive disease
    -
    -
    1
         Protocol deviation
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V212 Consistency Lots (excluding High Antigen Lot)
    Reporting group description
    		 V212 consistency Lot 1, 2, or 3 (Excluding High Antigen Lot) administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Reporting group title
    V212 High Antigen Lot
    Reporting group description
    		 V212 High Antigen Lot administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to V212 administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Reporting group values
    		 V212 Consistency Lots (excluding High Antigen Lot) V212 High Antigen Lot Placebo Total
    Number of subjects
    		 560 106 564 1230
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 448 83 451 982
        From 65-84 years
    		 112 23 113 248
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.1 ( 12.6 ) 54.3 ( 12.2 ) 54.1 ( 12.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 203 48 204 455
        Male
    		 357 58 360 775

    End points

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    End points reporting groups
    Reporting group title
    V212 Consistency Lots (excluding High Antigen Lot)
    Reporting group description
    		 V212 consistency Lot 1, 2, or 3 (Excluding High Antigen Lot) administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Reporting group title
    V212 High Antigen Lot
    Reporting group description
    		 V212 High Antigen Lot administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to V212 administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Subject analysis set title
    All V212 (including High Antigen Lot)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    V212 Consistency Lot 1, 2, 3 or High Antigen Lot administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Placebo to V212 administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT. Follow-up is for up to approximately 57 months.

    Primary: Incidence of Confirmed Herpes-Zoster

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    End point title
    		 Incidence of Confirmed Herpes-Zoster [1]
    End point description
    Clinical criteria for suspected HZ cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure. This analysis was based on Modified Intent-to-Treat (MITT) population. The MITT population included all randomized participants who received at least one dose of vaccination and underwent auto-HCT. This endpoint did not apply to participants receiving the V212 High Antigen Lot.
    End point type
    Primary
    End point timeframe
    Up to approximately 57 months
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint did not apply to participants receiving the V212 High Antigen lot.
    End point values
    		 V212 Consistency Lots (excluding High Antigen Lot) Placebo
    Number of subjects analysed
    538
    535
    Units: Number of cases per 1000 person years
        number (confidence interval 95%)
    32.889 (23.703 to 44.456)
    91.883 (75.725 to 110.469)
    Statistical analysis title
    		 Vaccine Efficacy: Incidence of Confirmed HZ
    Statistical analysis description
    Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 (excluding High Antigen Lot) group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is >0.25.
    Comparison groups
    Placebo v V212 Consistency Lots (excluding High Antigen Lot)
    Number of subjects included in analysis
    1073
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Vaccine Efficacy
    Point estimate
    0.638
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.484
         upper limit
    		 0.746
    Notes
    [2] - Point estimate and 95% Confidence Interval (CI) of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (< 50 years of age versus ≥ 50 years of age), and expected duration of antiviral prophylaxis (≤ 3 months versus 3 to 6 months after auto-HCT).

    Primary: Percentage of Participants with One or More Serious Adverse Event

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    End point title
    		 Percentage of Participants with One or More Serious Adverse Event
    End point description
    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The analysis population included all participants who received ≥1 dose of vaccination or placebo and had safety follow-up. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses. Safety analyses in the study were based on the pooled data from Consistency Lot 1, 2, 3 and High Antigen Lot.
    End point type
    Primary
    End point timeframe
    Up to 28 days after vaccination 4
    End point values
    		 All V212 (including High Antigen Lot) Placebo
    Number of subjects analysed
    657
    554
    Units: Percentage of participants
        number (not applicable)
    32.9
    32.7
    Statistical analysis title
    		 Risk Difference
    Statistical analysis description
    Risk difference and 95% confidence intervals are based on Miettinen & Nurminen method stratified by age and intended duration of antiviral prophylaxis.
    Comparison groups
    All V212 (including High Antigen Lot) v Placebo
    Number of subjects included in analysis
    1211
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 5.5

    Secondary: Incidence of Moderate to Severe Herpes-Zoster-Associated Pain

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    End point title
    		 Incidence of Moderate to Severe Herpes-Zoster-Associated Pain [3]
    End point description
    Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory at any time from HZ onset through the end of the 6 month HZ-follow-up period. This analysis was based on Modified Intent-to-Treat (MITT) population. The MITT population included all randomized participants who received at least one dose of vaccination and underwent auto-HCT. This endpoint did not apply to participants receiving the V212 High Antigen Lot.
    End point type
    Secondary
    End point timeframe
    Up to 6 months after the onset of HZ
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint did not apply to participants receiving the V212 High Antigen lot.
    End point values
    		 V212 Consistency Lots (excluding High Antigen Lot) Placebo
    Number of subjects analysed
    538
    535
    Units: Number of cases per 1000 person years
        number (confidence interval 95%)
    14.878 (8.958 to 23.234)
    49.601 (37.941 to 63.714)
    Statistical analysis title
    		 Vaccine Efficacy: Incidence of HZ-associated Pain
    Statistical analysis description
    Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ pain in the V212 (excluding High Antigen Lot) group versus the placebo group.
    Comparison groups
    Placebo v V212 Consistency Lots (excluding High Antigen Lot)
    Number of subjects included in analysis
    1073
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Vaccine efficacy
    Point estimate
    0.695
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 0.818
    Notes
    [4] - Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for vaccination group, age (<50 years of age versus ≥50 years of age),and expected duration of antiviral prophylaxis (≤3 months versus >3 and ≤6 months after auto-HCT).

    Secondary: Incidence of Herpes-Zoster Complications

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    End point title
    		 Incidence of Herpes-Zoster Complications [5]
    End point description
    The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ. This analysis was based on Modified Intent-to-Treat (MITT) population. The MITT population included all randomized participants who received at least one dose of vaccination and underwent auto-HCT. This endpoint did not apply to participants receiving the V212 High Antigen Lot.
    End point type
    Secondary
    End point timeframe
    Up to approximately 57 months
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint did not apply to participants receiving the V212 High Antigen lot.
    End point values
    		 V212 Consistency Lots (excluding High Antigen Lot) Placebo
    Number of subjects analysed
    538
    535
    Units: Number of cases per 1000 person years
        number (confidence interval 95%)
    9.397 (4.855 to 16.414)
    35.77 (25.996 to 48.03)
    Statistical analysis title
    		 Vaccine Efficacy: Incidence of HZ Complications
    Statistical analysis description
    Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ complications in the V212 [excluding High Antigen Lot] group versus the placebo group.
    Comparison groups
    Placebo v V212 Consistency Lots (excluding High Antigen Lot)
    Number of subjects included in analysis
    1073
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Vaccine efficacy
    Point estimate
    0.735
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.498
         upper limit
    		 0.86
    Notes
    [6] - Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for vaccination group, age (<50 years of age versus ≥50 years of age), and expected duration of antiviral prophylaxis (≤3 months versus >3 and ≤6 months after auto-HCT).

    Secondary: Incidence of Postherpetic Neuralgia

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    End point title
    		 Incidence of Postherpetic Neuralgia [7]
    End point description
    Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with a pain in the last 24 hours score of 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset. This analysis was based on Modified Intent-to-Treat (MITT) population. The MITT population included all randomized participants who received at least one dose of vaccination and underwent auto-HCT. This endpoint did not apply to participants receiving the V212 High Antigen Lot.
    End point type
    Secondary
    End point timeframe
    Up to 6 months after the onset of HZ rash
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint did not apply to participants receiving the V212 High Antigen lot.
    End point values
    		 V212 Consistency Lots (excluding High Antigen Lot) Placebo
    Number of subjects analysed
    538
    535
    Units: Number of cases per 1000 person years
        number (confidence interval 95%)
    2.349 (0.484 to 6.865)
    14.636 (8.674 to 23.132)
    Statistical analysis title
    		 Vaccine Efficacy: Incidence of PHN
    Statistical analysis description
    Vaccine efficacy was calculated as 1 minus the hazard ratio of PHN in the V212 [excluding High Antigen Lot] group versus placebo group.
    Comparison groups
    Placebo v V212 Consistency Lots (excluding High Antigen Lot)
    Number of subjects included in analysis
    1073
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Vaccine efficacy
    Point estimate
    0.837
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.446
         upper limit
    		 0.952
    Notes
    [8] - Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 years of age versus ≥50 years of age), and expected duration of antiviral prophylaxis (≤3 months versus 3 to 6 months after auto-HCT).

    Other pre-specified: Percentage of Participants with Study Medication Withdrawn due to an Adverse Event

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    End point title
    		 Percentage of Participants with Study Medication Withdrawn due to an Adverse Event
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. The analysis population included all subjects who received ≥1 dose of vaccination or placebo and had safety follow-up. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses. Safety analyses in the study were based on the pooled data from Consistency Lot 1, 2, 3 and High Antigen Lot.
    End point type
    Other pre-specified
    End point timeframe
    Up to 28 days after vaccination 4
    End point values
    		 All V212 (including High Antigen Lot) Placebo
    Number of subjects analysed
    657
    554
    Units: Percentage of participants
        number (not applicable)
    3
    3.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 57 months after vaccination 1
    Adverse event reporting additional description
    All Subjects as Treated population included all who received ≥1 dose of vaccination or placebo and had safety follow-up. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses. Safety analyses in the study were based on the pooled data from Consistency Lot 1, 2, 3 and High Antigen Lot.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    V212 [including High Antigen Lot]
    Reporting group description
    		 V212 Consistency Lot 1, 2, 3 or High Antigen Lot administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to V212 administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.

    Serious adverse events
    		 V212 [including High Antigen Lot] Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    420 / 657 (63.93%)
    374 / 554 (67.51%)
         number of deaths (all causes)
    136
    107
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    0 / 657 (0.00%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Acute promyelocytic leukaemia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anaplastic large cell lymphoma T- and null-cell types
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anaplastic large cell lymphoma T- and null-cell types recurrent
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anaplastic large-cell lymphoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angiocentric lymphoma
         subjects affected / exposed
    0 / 657 (0.00%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioimmunoblastic T-cell lymphoma recurrent
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    B-cell lymphoma
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma recurrent
         subjects affected / exposed
    3 / 657 (0.46%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    B-cell lymphoma stage IV
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia recurrent
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    10 / 657 (1.52%)
    10 / 554 (1.81%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Diffuse large B-cell lymphoma recurrent
         subjects affected / exposed
    14 / 657 (2.13%)
    10 / 554 (1.81%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 6
    0 / 6
    Diffuse large B-cell lymphoma refractory
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Extranodal marginal zone B-cell lymphoma (MALT type) recurrent
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III recurrent
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    8 / 657 (1.22%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Hodgkin's disease nodular sclerosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease recurrent
         subjects affected / exposed
    7 / 657 (1.07%)
    6 / 554 (1.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Langerhans' cell histiocytosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia recurrent
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lymphoma
         subjects affected / exposed
    9 / 657 (1.37%)
    6 / 554 (1.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lymphoplasmacytoid lymphoma/immunocytoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant lymphoid neoplasm
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    1 / 657 (0.15%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 657 (0.15%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Mantle cell lymphoma recurrent
         subjects affected / exposed
    10 / 657 (1.52%)
    9 / 554 (1.62%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Metastases to meninges
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    6 / 657 (0.91%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Non-Hodgkin's lymphoma recurrent
         subjects affected / exposed
    10 / 657 (1.52%)
    13 / 554 (2.35%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    Non-Hodgkin's lymphoma refractory
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nonkeratinising carcinoma of nasopharynx
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 657 (0.15%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraneoplastic syndrome
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion malignant
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral T-cell lymphoma unspecified
         subjects affected / exposed
    3 / 657 (0.46%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Peripheral T-cell lymphoma unspecified recurrent
         subjects affected / exposed
    4 / 657 (0.61%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Plasma cell myeloma
         subjects affected / exposed
    67 / 657 (10.20%)
    51 / 554 (9.21%)
         occurrences causally related to treatment / all
    0 / 75
    0 / 57
         deaths causally related to treatment / all
    0 / 24
    0 / 15
    Plasma cell myeloma recurrent
         subjects affected / exposed
    50 / 657 (7.61%)
    53 / 554 (9.57%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 56
         deaths causally related to treatment / all
    0 / 13
    0 / 15
    Plasmablastic lymphoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Precursor T-lymphoblastic lymphoma/leukaemia
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Precursor T-lymphoblastic lymphoma/leukaemia recurrent
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Primary mediastinal large B-cell lymphoma
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal cancer
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal cancer recurrent
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell carcinoma
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    T-cell lymphoma recurrent
         subjects affected / exposed
    8 / 657 (1.22%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Tumour flare
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    7 / 657 (1.07%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 657 (0.00%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    5 / 657 (0.76%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venoocclusive disease
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Threatened labour
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 657 (0.61%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    5 / 657 (0.76%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    8 / 657 (1.22%)
    6 / 554 (1.08%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 657 (0.46%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Pneumatosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    33 / 657 (5.02%)
    26 / 554 (4.69%)
         occurrences causally related to treatment / all
    0 / 37
    1 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Acute graft versus host disease in skin
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyloidosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Engraftment syndrome
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Graft versus host disease in lung
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease in skin
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary amyloidosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 657 (0.46%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pneumonia syndrome
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    6 / 657 (0.91%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    3 / 657 (0.46%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 657 (0.46%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Restrictive pulmonary disease
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomania
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Schizoaffective disorder
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (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
    Allergic transfusion reaction
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed engraftment
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 657 (0.15%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal nerve injury
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post lumbar puncture syndrome
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (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
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant dysfunction
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    5 / 657 (0.76%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 657 (0.61%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac amyloidosis
         subjects affected / exposed
    0 / 657 (0.00%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Cardiac failure
         subjects affected / exposed
    3 / 657 (0.46%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    5 / 657 (0.76%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Autonomic nervous system imbalance
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    4 / 657 (0.61%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial venous sinus thrombosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Migraine
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    6 / 657 (0.91%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired haemophilia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    3 / 657 (0.46%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anaemia megaloblastic
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    42 / 657 (6.39%)
    38 / 554 (6.86%)
         occurrences causally related to treatment / all
    0 / 44
    0 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leukocytosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Methaemoglobinaemia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    4 / 657 (0.61%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sickle cell anaemia with crisis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    8 / 657 (1.22%)
    7 / 554 (1.26%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular haematoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphthous ulcer
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    7 / 657 (1.07%)
    15 / 554 (2.71%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyskinesia oesophageal
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 657 (0.15%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    3 / 657 (0.46%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal ischaemia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteritis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 657 (0.46%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic insufficiency
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 657 (0.61%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatous liver disease
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hydrocholecystis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis exfoliative
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash vesicular
         subjects affected / exposed
    3 / 657 (0.46%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    8 / 657 (1.22%)
    10 / 554 (1.81%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute prerenal failure
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 657 (0.61%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal injury
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Actinomycotic pulmonary infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspergilloma
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    6 / 657 (0.91%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    BK virus infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    4 / 657 (0.61%)
    7 / 554 (1.26%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    4 / 657 (0.61%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    6 / 657 (0.91%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Candida sepsis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    4 / 657 (0.61%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic hepatitis B
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    5 / 657 (0.76%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    3 / 657 (0.46%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coxsackie viral infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus oesophagitis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    5 / 657 (0.76%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 657 (0.46%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis bacterial
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    3 / 657 (0.46%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal oesophagitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 657 (0.76%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal candidiasis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    3 / 657 (0.46%)
    12 / 554 (2.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection in an immunocompromised host
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    8 / 657 (1.22%)
    7 / 554 (1.26%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    3 / 657 (0.46%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung infection pseudomonal
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis pneumococcal
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningoencephalitis herpetic
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    3 / 657 (0.46%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Oral candidiasis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal bacteraemia
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 657 (0.15%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumocystis jirovecii infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    61 / 657 (9.28%)
    56 / 554 (10.11%)
         occurrences causally related to treatment / all
    0 / 74
    1 / 67
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Pneumonia bacterial
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    2 / 657 (0.30%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pseudomonas infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mycosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinitis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    19 / 657 (2.89%)
    12 / 554 (2.17%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 14
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Sepsis syndrome
         subjects affected / exposed
    1 / 657 (0.15%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    7 / 657 (1.07%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Sialoadenitis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 657 (0.15%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    4 / 657 (0.61%)
    3 / 554 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    2 / 657 (0.30%)
    4 / 554 (0.72%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 657 (0.15%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 657 (0.76%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    8 / 657 (1.22%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 657 (0.30%)
    5 / 554 (0.90%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 657 (0.30%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    3 / 657 (0.46%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Food intolerance
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    2 / 657 (0.30%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 657 (0.00%)
    2 / 554 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactose intolerance
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tetany
         subjects affected / exposed
    0 / 657 (0.00%)
    1 / 554 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 657 (0.15%)
    0 / 554 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V212 [including High Antigen Lot] Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    625 / 657 (95.13%)
    512 / 554 (92.42%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    33 / 657 (5.02%)
    33 / 554 (5.96%)
         occurrences all number
    38
    36
    Hypotension
         subjects affected / exposed
    57 / 657 (8.68%)
    48 / 554 (8.66%)
         occurrences all number
    64
    52
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    45 / 657 (6.85%)
    34 / 554 (6.14%)
         occurrences all number
    47
    35
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    44 / 657 (6.70%)
    46 / 554 (8.30%)
         occurrences all number
    46
    51
    Dysgeusia
         subjects affected / exposed
    29 / 657 (4.41%)
    28 / 554 (5.05%)
         occurrences all number
    29
    28
    Headache
         subjects affected / exposed
    131 / 657 (19.94%)
    114 / 554 (20.58%)
         occurrences all number
    149
    141
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    175 / 657 (26.64%)
    134 / 554 (24.19%)
         occurrences all number
    201
    168
    Febrile neutropenia
         subjects affected / exposed
    184 / 657 (28.01%)
    135 / 554 (24.37%)
         occurrences all number
    191
    138
    Leukopenia
         subjects affected / exposed
    33 / 657 (5.02%)
    32 / 554 (5.78%)
         occurrences all number
    34
    41
    Neutropenia
         subjects affected / exposed
    163 / 657 (24.81%)
    129 / 554 (23.29%)
         occurrences all number
    187
    157
    Pancytopenia
         subjects affected / exposed
    63 / 657 (9.59%)
    53 / 554 (9.57%)
         occurrences all number
    64
    54
    Thrombocytopenia
         subjects affected / exposed
    238 / 657 (36.23%)
    212 / 554 (38.27%)
         occurrences all number
    289
    264
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    72 / 657 (10.96%)
    60 / 554 (10.83%)
         occurrences all number
    77
    68
    Chills
         subjects affected / exposed
    39 / 657 (5.94%)
    35 / 554 (6.32%)
         occurrences all number
    44
    42
    Fatigue
         subjects affected / exposed
    144 / 657 (21.92%)
    121 / 554 (21.84%)
         occurrences all number
    159
    131
    Injection site erythema
         subjects affected / exposed
    153 / 657 (23.29%)
    14 / 554 (2.53%)
         occurrences all number
    323
    19
    Injection site pain
         subjects affected / exposed
    133 / 657 (20.24%)
    21 / 554 (3.79%)
         occurrences all number
    283
    24
    Injection site pruritus
         subjects affected / exposed
    35 / 657 (5.33%)
    4 / 554 (0.72%)
         occurrences all number
    52
    5
    Injection site swelling
         subjects affected / exposed
    124 / 657 (18.87%)
    9 / 554 (1.62%)
         occurrences all number
    257
    9
    Mucosal inflammation
         subjects affected / exposed
    254 / 657 (38.66%)
    226 / 554 (40.79%)
         occurrences all number
    271
    244
    Oedema peripheral
         subjects affected / exposed
    77 / 657 (11.72%)
    65 / 554 (11.73%)
         occurrences all number
    89
    72
    Pyrexia
         subjects affected / exposed
    317 / 657 (48.25%)
    248 / 554 (44.77%)
         occurrences all number
    526
    374
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    87 / 657 (13.24%)
    78 / 554 (14.08%)
         occurrences all number
    103
    81
    Abdominal pain upper
         subjects affected / exposed
    51 / 657 (7.76%)
    34 / 554 (6.14%)
         occurrences all number
    51
    35
    Constipation
         subjects affected / exposed
    107 / 657 (16.29%)
    102 / 554 (18.41%)
         occurrences all number
    120
    113
    Diarrhoea
         subjects affected / exposed
    394 / 657 (59.97%)
    341 / 554 (61.55%)
         occurrences all number
    492
    396
    Dyspepsia
         subjects affected / exposed
    61 / 657 (9.28%)
    47 / 554 (8.48%)
         occurrences all number
    65
    52
    Nausea
         subjects affected / exposed
    370 / 657 (56.32%)
    319 / 554 (57.58%)
         occurrences all number
    452
    391
    Stomatitis
         subjects affected / exposed
    83 / 657 (12.63%)
    51 / 554 (9.21%)
         occurrences all number
    94
    56
    Vomiting
         subjects affected / exposed
    211 / 657 (32.12%)
    200 / 554 (36.10%)
         occurrences all number
    265
    260
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    76 / 657 (11.57%)
    80 / 554 (14.44%)
         occurrences all number
    84
    93
    Dyspnoea
         subjects affected / exposed
    55 / 657 (8.37%)
    36 / 554 (6.50%)
         occurrences all number
    60
    36
    Epistaxis
         subjects affected / exposed
    41 / 657 (6.24%)
    24 / 554 (4.33%)
         occurrences all number
    48
    26
    Oropharyngeal pain
         subjects affected / exposed
    68 / 657 (10.35%)
    43 / 554 (7.76%)
         occurrences all number
    78
    48
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    33 / 657 (5.02%)
    22 / 554 (3.97%)
         occurrences all number
    37
    31
    Pruritus
         subjects affected / exposed
    66 / 657 (10.05%)
    38 / 554 (6.86%)
         occurrences all number
    72
    45
    Rash
         subjects affected / exposed
    89 / 657 (13.55%)
    74 / 554 (13.36%)
         occurrences all number
    110
    84
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    35 / 657 (5.33%)
    31 / 554 (5.60%)
         occurrences all number
    38
    32
    Insomnia
         subjects affected / exposed
    84 / 657 (12.79%)
    68 / 554 (12.27%)
         occurrences all number
    91
    71
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    56 / 657 (8.52%)
    46 / 554 (8.30%)
         occurrences all number
    63
    51
    Pain in extremity
         subjects affected / exposed
    33 / 657 (5.02%)
    24 / 554 (4.33%)
         occurrences all number
    35
    26
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    152 / 657 (23.14%)
    132 / 554 (23.83%)
         occurrences all number
    161
    150
    Hyperglycaemia
         subjects affected / exposed
    33 / 657 (5.02%)
    16 / 554 (2.89%)
         occurrences all number
    40
    16
    Hypocalcaemia
         subjects affected / exposed
    55 / 657 (8.37%)
    40 / 554 (7.22%)
         occurrences all number
    65
    45
    Hypokalaemia
         subjects affected / exposed
    141 / 657 (21.46%)
    111 / 554 (20.04%)
         occurrences all number
    165
    135
    Hypomagnesaemia
         subjects affected / exposed
    76 / 657 (11.57%)
    62 / 554 (11.19%)
         occurrences all number
    88
    75
    Hypophosphataemia
         subjects affected / exposed
    41 / 657 (6.24%)
    40 / 554 (7.22%)
         occurrences all number
    48
    42

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2010
    Amendment 1: The primary reasons for this amendment are to change the pre-specified criteria for success for the primary efficacy hypothesis and to elevate critical exploratory efficacy endpoints to secondary efficacy endpoints.
    13 Oct 2010
    Amendment 2: The primary clinical efficacy endpoint was modified to exclude recipients of inactivated VZV vaccine High Antigen Lot. Therefore, the primary clinical efficacy endpoint included the incidence of HZ among the inactivated VZV Consistency Lot 1, 2, 3 and placebo recipients only.
    02 Jan 2013
    Amendment 4: The following text was added, anticipating that an original vaccine lot might expire prior to all participants completing their 4-dose regimen: A given participant is anticipated to receive all 4 doses in the series from the same lot. In the event that the vaccine lot expires prior to a participant receiving all 4 doses of study vaccine, doses will be administered from a new lot of comparable antigen content.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    22 Sep 2012
    The Data Monitoring Committee temporarily paused enrollment and vaccination to evaluate preliminary reports of disseminated rash lesions that tested PCR positive for VZV Oka/Merck (vaccine strain) in another V212 study. The available evidence suggested that these PCR results were likely false positive.
    02 Oct 2012

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