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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

    Summary
    EudraCT number
    		 2011-001112-53
    Trial protocol
    		 GR   ES   BE   NL   AT   DK   IT   DE  
    Global end of trial date
    05 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2017
    First version publication date
    20 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    20101129
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01493505
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    05 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to determine if 6 cycles of paclitaxel and carboplatin plus trebananib followed by 18 months of trebananib maintenance improves progression-free survival compared with 6 cycles of paclitaxel and carboplatin plus placebo followed by 18 months of placebo maintenance in the first-line treatment of patients with International Federation of Gynecology and Obstetrics (FIGO) stage III-IV epithelial ovarian, primary peritoneal, or fallopian tube cancers.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. Essential documents will be retained in accordance with ICH GCP. All subjects provided written informed consent before undergoing any study-related procedures, including screening procedures. The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). No subjects were recruited into the study and no investigational product (IP) was shipped until the IRB/IEC gave written approval of the protocol and ICF and Amgen received copies of these approvals.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jan 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 75 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 25
    Country: Number of subjects enrolled
    United States: 299
    Country: Number of subjects enrolled
    Austria: 22
    Country: Number of subjects enrolled
    Belgium: 89
    Country: Number of subjects enrolled
    Denmark: 20
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Greece: 49
    Country: Number of subjects enrolled
    Italy: 102
    Country: Number of subjects enrolled
    Netherlands: 8
    Country: Number of subjects enrolled
    Spain: 97
    Country: Number of subjects enrolled
    Hong Kong: 23
    Country: Number of subjects enrolled
    Japan: 51
    Country: Number of subjects enrolled
    Korea, Republic of: 75
    Country: Number of subjects enrolled
    Russian Federation: 93
    Worldwide total number of subjects
    1015
    EEA total number of subjects
    449
    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)
    702
    From 65 to 84 years
    312
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 206 centers in Asia, Australia, Canada, Russia, the United States, and Western Europe. Participants were enrolled from 30 January 2012 until 25 February 2014.

    Pre-assignment
    Screening details
    		 Participants were randomized in a 2:1 ratio to receive either trebananib, paclitaxel and carboplatin or placebo, paclitaxel and carboplatin. Randomization was stratified based on carboplatin dose and FIGO disease stage and either category of residual disease after primary debulking surgery (PDS) or planned interval debulking surgery (IDS).

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo + Paclitaxel + Carboplatin
    Arm description
    		 Participants received placebo intravenous (IV) infusion once a week, paclitaxel 175 mg/m² by IV infusion once every 3 weeks (Q3W), and carboplatin at an area under the curve (AUC) 5 or 6 IV Q3W for 6 cycles followed by placebo IV once a week maintenance for 18 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Administered intravenously once every week

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Taxol®
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 175 mg/m², administered as an intravenous infusion over 3 hours.

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Paraplatin®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to an AUC/time curve of 5 or 6 administered by intravenous infusion.

    Arm title
    		 Trebananib + Paclitaxel + Carboplatin
    Arm description
    		 Participants received trebananib 15 mg/kg IV once a week, paclitaxel 175 mg/m² infusion Q3W, and carboplatin AUC 5 or 6 IV Q3W for 6 cycles followed by trebananib 15 mg/kg IV once a week maintenance for 18 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trebananib
    Investigational medicinal product code
    AMG 386
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Trebananib 15 mg/kg administered intravenously once every week

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Paraplatin®
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was dosed using the glomerular filtration rate (GFR) and Calvert formula to an AUC/time curve of 5 or 6 administered by intravenous infusion.

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Taxol®
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel 175 mg/m², administered as an intravenous infusion over 3 hours.

    Number of subjects in period 1
    		Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Started
    337
    678
    Received trebananib/placebo
    332
    663
    Received paclitaxel
    336
    670
    Received carboplatin
    337
    671
    Completed
    0
    0
    Not completed
    337
    678
         Consent withdrawn by subject
    29
    79
         Death
    134
    262
         Other
    166
    319
         Lost to follow-up
    8
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received placebo intravenous (IV) infusion once a week, paclitaxel 175 mg/m² by IV infusion once every 3 weeks (Q3W), and carboplatin at an area under the curve (AUC) 5 or 6 IV Q3W for 6 cycles followed by placebo IV once a week maintenance for 18 months.

    Reporting group title
    Trebananib + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received trebananib 15 mg/kg IV once a week, paclitaxel 175 mg/m² infusion Q3W, and carboplatin AUC 5 or 6 IV Q3W for 6 cycles followed by trebananib 15 mg/kg IV once a week maintenance for 18 months.

    Reporting group values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin Total
    Number of subjects
    		 337 678 1015
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    		 231 471 702
        From 65-84 years
    		 105 207 312
        85 years and over
    		 1 0 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ( 10.9 ) 58.4 ( 10.8 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 337 678 1015
        Male
    		 0 0 0
    Cancer Type
    Units: Subjects
        Ovarian cancer
    		 290 583 873
        Primary peritoneal carcinoma
    		 31 65 96
        Fallopian tube cancer
    		 16 29 45
        Not available
    		 0 1 1
    Stratification Factor: Carboplatin Dose
    Units: Subjects
        AUC 5
    		 156 317 473
        AUC 6
    		 181 361 542
    Stratification Factor: FIGO Stage
    Units: Subjects
        Stage IIIA/IIIB
    		 30 60 90
        Stage IIIC/IV
    		 307 618 925
    Stratification Factor: Debulking Surgery
    Units: Subjects
        Received PDS: Optimally debulked
    		 118 238 356
        Received PDS: Suboptimally debulked
    		 95 193 288
        Planning for IDS
    		 124 247 371

    End points

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    End points reporting groups
    Reporting group title
    Placebo + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received placebo intravenous (IV) infusion once a week, paclitaxel 175 mg/m² by IV infusion once every 3 weeks (Q3W), and carboplatin at an area under the curve (AUC) 5 or 6 IV Q3W for 6 cycles followed by placebo IV once a week maintenance for 18 months.

    Reporting group title
    Trebananib + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received trebananib 15 mg/kg IV once a week, paclitaxel 175 mg/m² infusion Q3W, and carboplatin AUC 5 or 6 IV Q3W for 6 cycles followed by trebananib 15 mg/kg IV once a week maintenance for 18 months.

    Primary: Progression-free Survival

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    End point title
    		 Progression-free Survival
    End point description
    Progression-free survival (PFS) was defined as the time from randomization to the earliest of disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with modifications or death from any cause. Subjects not meeting these criteria by the analysis data cutoff date were censored at their last radiographic-evaluable disease assessment date. Events of radiographic progression that occurred after the initiation of subsequent anticancer therapy were not considered PFS events and were censored at the last radiographic assessment before the initiation of subsequent anticancer therapy. Deaths occurring after initiation of subsequent anticancer therapy were considered PFS events. Tumor response was determined by the investigator. Progressive disease was defined as at least a 20% increase in the size of target lesions, with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions.
    End point type
    Primary
    End point timeframe
    From randomization to the data cut-off date; median overall study follow-up time was 151.3 weeks in both treatment groups.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    337
    678
    Units: months
        median (confidence interval 95%)
    15.1 (12.7 to 16.4)
    16.7 (15.0 to 17.7)
    Statistical analysis title
    		 Analysis of Progression-free Survival
    Comparison groups
    Placebo + Paclitaxel + Carboplatin v Trebananib + Paclitaxel + Carboplatin
    Number of subjects included in analysis
    1015
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.31 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.08
    Notes
    [1] - Log-rank test stratified by the stratification factors FIGO disease stage and category of residual disease after PDS or planned IDS

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the time from the randomization date to the date of death from any cause. Subjects who were lost to follow-up before the analysis data cutoff date or were alive by the analysis data cutoff date were censored at their last contact date (last known to be alive). "99999" indicates values that could not be estimated.
    End point type
    Secondary
    End point timeframe
    From randomization to the data cut-off date; median overall study follow-up time was 151.3 weeks in both treatment groups.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    337
    678
    Units: months
        median (confidence interval 95%)
    48.8 (43.1 to 99999)
    48.8 (44.7 to 99999)
    Statistical analysis title
    		 Overall Survival Analysis
    Comparison groups
    Placebo + Paclitaxel + Carboplatin v Trebananib + Paclitaxel + Carboplatin
    Number of subjects included in analysis
    1015
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.87 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.25
    Notes
    [2] - Log rank test stratified by FIGO disease stage and category of residual disease after PDS or planned IDS.

    Secondary: Number of Participants with Adverse Events

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    End point title
    		 Number of Participants with Adverse Events
    End point description
    Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, except edema AE. The investigator assessed whether each adverse event was possibly related to the trebananib / placebo and/or paclitaxel or carboplatin. The safety analysis set was defined as the subset of randomized subjects who received at least 1 dose of any study drug. One subject randomized to the placebo group received trebananib and was included in the trebananib group for safety analysis.
    End point type
    Secondary
    End point timeframe
    From first dose of any study treatment until 30 days after the last dose; median duration was 338 days for the placebo group and 251 days for trebananib group.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    336
    675
    Units: participants
        Any adverse event (AE)
    327
    666
        Grade ≥ 3
    237
    510
        Grade ≥ 4
    102
    227
        Fatal adverse events
    1
    20
        Serious adverse events (SAE)
    104
    269
        AE leading to discontinuation of trebananib
    44
    186
        SAE leading to discontinuation of trebananib
    15
    60
        AE leading to discontinuation of paclitaxel
    29
    63
        SAE leading to discontinuation of paclitaxel
    10
    17
        AE leading to discontinuation of carboplatin
    28
    49
        SAE leading to discontinuation of carboplatin
    8
    16
        AE leading to discontinuation from all study drugs
    16
    30
        SAE leading to discontinuation of all study drugs
    7
    14
        Trebananib-related adverse events
    207
    516
        Paclitaxel-related adverse events
    316
    649
        Carboplatin-related adverse events
    310
    632
    No statistical analyses for this end point

    Secondary: Maximum Observed Concentration (Cmax) of Trebananib

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    End point title
    		 Maximum Observed Concentration (Cmax) of Trebananib [3]
    End point description
    Trebananib pharmacokinetic (PK) concentrations below the lower limit of quantification of 20 ng/mL were set to 0 before data analysis. Week 7 values were based on subjects with 3 consecutive doses to ensure the steady state was reached. The PK analysis set was defined as a subset of subjects in the safety analysis set who had evaluable concentration data.
    End point type
    Secondary
    End point timeframe
    Week 1 (after single administration) and week 7 (at steady state), at the end of infusion
    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: PK analyses were only performed in subjects in the trebananib treatment group.
    End point values
    		 Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    537 [4]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Week 1 (n = 537)
    271 ( 114 )
        Week 7 (n = 441)
    309 ( 119 )
    Notes
    [4] - PK analysis set with available data at each time point
    No statistical analyses for this end point

    Secondary: Minimum Observed Concentration (Cmin) of Trebananib

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    End point title
    		 Minimum Observed Concentration (Cmin) of Trebananib [5]
    End point description
    Week 7 values were based on subjects with 3 consecutive doses to ensure the steady state was reached. Such criterion was not implemented for weeks 10 and 19. Week 10 Cmin values include only primary debulking surgery subjects
    End point type
    Secondary
    End point timeframe
    Weeks 7, 10, and 19, predose
    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: PK analyses were only performed in subjects in the trebananib treatment group.
    End point values
    		 Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    438 [6]
    Units: μg/mL
    arithmetic mean (standard deviation)
        Week 7 (n = 438)
    24.3 ( 14.4 )
        Week 10 (n = 297)
    24.1 ( 17.6 )
        Week 19 (n = 386)
    25.6 ( 16.6 )
    Notes
    [6] - PK analysis set with available data at each time point
    No statistical analyses for this end point

    Secondary: Number of Participants who Developed Anti-Trebananib Antibodies

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    End point title
    		 Number of Participants who Developed Anti-Trebananib Antibodies
    End point description
    Participants who developed antibody binding are defined as participants with a negative result at baseline and a positive result post-baseline.
    End point type
    Secondary
    End point timeframe
    Day 1 of weeks 1, 10, 19, and 30 days after last dose
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    309 [7]
    594 [8]
    Units: participants
        Binding antibody positive
    11
    72
        Neutralizing antibody positive
    0
    0
    Notes
    [7] - Subjects with a post-baseline result
    [8] - Subjects with a post-baseline result
    No statistical analyses for this end point

    Secondary: Change from Baseline in Functional Assessment of Cancer Therapy – Ovary (FACT-O) Summary Score

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    End point title
    		 Change from Baseline in Functional Assessment of Cancer Therapy – Ovary (FACT-O) Summary Score
    End point description
    The FACT-O evaluates the health-related quality of life (HRQOL) and symptoms in patients with ovarian cancer. It consists of the FACT-G, a 27 item general cancer questionnaire and a 12-item ovarian cancer-specific subscale (OCS). Each item is scored by the participant on a scale from 0 (not at all true) to 4 (very much true). The total score ranges from 0 to 156; a higher total score indicates better quality of life or less severe symptoms. The patient-reported outcomes (PRO) analysis set is defined as a subset of randomized subjects who have a baseline PRO assessment and at least one post-baseline PRO assessment prior to disease progression and the initiation of subsequent anticancer therapy.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 7, 13 and during the maintenance phase at months 3, 6, 9, 12, 15 and 18, and the safety follow-up visit 30 days after last dose.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    293 [9]
    564 [10]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 7 (n = 272, 528)
    4.4 ( 15.7 )
    0.7 ( 15.2 )
        Week 13 (n = 250, 459)
    5.5 ( 16.5 )
    0.7 ( 16.4 )
        Month 3 (n = 190, 294)
    12.1 ( 16.5 )
    8.9 ( 17.8 )
        Month 6 (n = 142, 208)
    13.7 ( 15.7 )
    9.2 ( 17.4 )
        Month 9 (n = 98, 160)
    13.1 ( 17.0 )
    8.4 ( 16.8 )
        Month 12 (n = 70, 117)
    14.0 ( 14.7 )
    8.2 ( 17.9 )
        Month 15 (n = 45, 84)
    10.1 ( 15.3 )
    9.3 ( 18.2 )
        Month 18 (n = 7, 20)
    19.4 ( 19.9 )
    14.1 ( 18.9 )
        Safety follow-up (n = 69, 183)
    13.1 ( 20.0 )
    4.5 ( 18.7 )
    Notes
    [9] - PRO analysis set with available data at each time point
    [10] - PRO analysis set with available data at each time point
    No statistical analyses for this end point

    Secondary: Change from Baseline in FACT-O Ovarian Cancer-specific (OCS) Subscale

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    End point title
    		 Change from Baseline in FACT-O Ovarian Cancer-specific (OCS) Subscale
    End point description
    The FACT-O evaluates the health-related quality of life (HRQOL) and symptoms in patients with ovarian cancer. It consists of the FACT-G, a 27 item general cancer questionnaire and a 12-item ovarian cancer-specific subscale (OCS). The OCS consists of 12 symptom items including swelling in stomach area, cramps in stomach area, weight loss, hair loss, control of bowels, appetite, vomiting, ability to get around, liking the appearance of one’s body, being able to feel like a woman, interest in sex, and concern about ability to have children. Each item is scored by the participant on a scale from 0 (not at all true) to 4 (very much true). The OCS summary score ranges from 0 to 48, where a higher score indicates better quality of life or less severe symptoms. The PRO analysis set includes a subset of randomized subjects who had a baseline PRO assessment and at least one post-baseline PRO assessment prior to disease progression and the initiation of subsequent anticancer therapy.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 7, 13 and during the maintenance phase at months 3, 6, 9, 12, 15 and 18, and the safety follow-up visit 30 days after last dose.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    299 [11]
    581 [12]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 7 (n = 282, 554)
    1.6 ( 5.1 )
    0.7 ( 5.3 )
        Week 13 (n = 256, 477)
    2.0 ( 5.7 )
    1.0 ( 5.6 )
        Month 3 (n = 199, 305)
    4.2 ( 6.0 )
    3.7 ( 6.1 )
        Month 6 (n = 148, 219)
    4.3 ( 5.8 )
    3.6 ( 6.1 )
        Month 9 (n = 101, 165)
    3.9 ( 6.1 )
    3.4 ( 5.7 )
        Month 12 (n = 71, 120)
    4.4 ( 4.6 )
    3.5 ( 6.3 )
        Month 15 (n = 46, 85)
    3.1 ( 5.7 )
    3.7 ( 6.2 )
        Month 18 (n = 7, 21)
    6.2 ( 7.2 )
    5.6 ( 6.7 )
        Safety follow-up (n = 78, 195)
    4.2 ( 7.3 )
    2.3 ( 6.3 )
    Notes
    [11] - PRO analysis set with available data at each time point
    [12] - PRO analysis set with available data at each time point
    No statistical analyses for this end point

    Secondary: Change from Baseline in EuroQOL 5-Dimension (EQ-5D) Health Index Score

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    End point title
    		 Change from Baseline in EuroQOL 5-Dimension (EQ-5D) Health Index Score
    End point description
    The EQ-5D is a standardized instrument for use as a generic, preference-based measure of health outcome. The EQ-5D questionnaire captures two basic types of information, a descriptive “profile,” or “health state,” and an overall health rating using a visual analogue scale. The health state includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has 3 answer choices: 1 (no problems), 2 (moderate problems), and 3 (extreme problems). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and –0.594. A higher score indicates a more preferred health status with 1.0 representing perfect health. The PRO analysis set includes a subset of randomized subjects who had a baseline assessment and at least 1 post-baseline PRO assessment prior to disease progression and the initiation of subsequent anticancer therapy.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 7 and 13, and maintenance phase months 3, 6, 9, 12, 15, and 18 and the safety follow-up visit 30 days after last dose.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    290 [13]
    568 [14]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 7 (n = 269, 531)
    0.1 ( 0.2 )
    0.0 ( 0.2 )
        Week 13 (n = 245, 461)
    0.1 ( 0.2 )
    0.0 ( 0.3 )
        Month 3 (n = 192, 295)
    0.1 ( 0.2 )
    0.1 ( 0.2 )
        Month 6 (n = 140, 209)
    0.8 ( 0.2 )
    0.8 ( 0.2 )
        Month 9 (n = 96, 160)
    0.1 ( 0.2 )
    0.1 ( 0.2 )
        Month 12 (n = 68, 114)
    0.1 ( 0.2 )
    0.1 ( 0.3 )
        Month 15 (n = 44, 80)
    0.1 ( 0.2 )
    0.1 ( 0.3 )
        Month 18 (n = 7, 21)
    0.4 ( 0.3 )
    0.2 ( 0.2 )
        Safety follow-up (n = 76, 186)
    0.1 ( 0.3 )
    0.0 ( 0.3 )
    Notes
    [13] - PRO analysis set with available data at each time point
    [14] - PRO analysis set with available data at each time point
    No statistical analyses for this end point

    Secondary: Change from Baseline in EQ-5D Visual Analogue Scale Score

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    End point title
    		 Change from Baseline in EQ-5D Visual Analogue Scale Score
    End point description
    The EQ-5D is a standardized instrument for use as a generic, preference-based measure of health outcome. The EQ-5D questionnaire captures two basic types of information, a descriptive “profile,” or “health state,” and an overall health rating using a visual analogue scale (VAS). The visual analogue scale asks respondents to rate their present health status on a 0 - 100 visual analogue scale, with 0 labeled as “Worst imaginable health state” and 100 labeled as “Best imaginable health state.” The VAS score is determined by observing the point at which the subjects hand drawn line intersects the scale. The PRO analysis set includes the subset of randomized subjects who had a baseline assessment and at least 1 post-baseline PRO assessment prior to disease progression and the initiation of subsequent anticancer therapy.
    End point type
    Secondary
    End point timeframe
    Baseline and weeks 7 and 13, and maintenance phase months 3, 6, 9, 12, 15, and 18 and the safety follow-up visit 30 days after last dose.
    End point values
    		 Placebo + Paclitaxel + Carboplatin Trebananib + Paclitaxel + Carboplatin
    Number of subjects analysed
    286 [15]
    563 [16]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 7 (n = 267, 523)
    6.2 ( 18.4 )
    2.3 ( 18.5 )
        Week 13 (n = 242, 457)
    7.2 ( 18.0 )
    3.6 ( 18.3 )
        Month 3 (n = 185, 289)
    10.0 ( 20.3 )
    9.6 ( 19.1 )
        Month 6 (n = 138, 211)
    13.6 ( 17.1 )
    10.0 ( 20.3 )
        Month 9 (n = 98,159)
    12.7 ( 19.7 )
    10.4 ( 19.5 )
        Month 12 (n = 66, 117)
    14.1 ( 18.8 )
    11.1 ( 19.3 )
        Month 15 (n = 43, 81)
    12.7 ( 17.7 )
    11.6 ( 20.0 )
        Month 12 (n = 6, 20)
    20.8 ( 11.1 )
    22.5 ( 24.1 )
        Safety follow-up (n = 78, 188)
    14.1 ( 20.9 )
    6.5 ( 21.6 )
    Notes
    [15] - PRO analysis set with available data at each time point
    [16] - PRO analysis set with available data at each time point
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of any study drug up to 30 days after last dose; median duration was 338 days for placebo and 251 days for trebananib,
    Adverse event reporting additional description
    A total of 336 subjects in the placebo group and 675 subjects in the trebananib group received ≥ 1 dose of study treatment and were included in the safety analysis set (1 subject randomized to the placebo group received trebananib and was included in the trebananib group for safety analysis).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Trebananib + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received trebananib 15 mg/kg IV once a week, paclitaxel 175 mg/m² infusion Q3W, and carboplatin AUC 5 or 6 IV Q3W for 6 cycles followed by trebananib 15 mg/kg IV once a week maintenance for 18 months.

    Reporting group title
    Placebo + Paclitaxel + Carboplatin
    Reporting group description
    		 Participants received placebo intravenous (IV) infusion once a week, paclitaxel 175 mg/m² by IV infusion once every 3 weeks (Q3W), and carboplatin at an area under the curve (AUC) 5 or 6 IV Q3W for 6 cycles followed by placebo IV once a week maintenance for 18 months.

    Serious adverse events
    		 Trebananib + Paclitaxel + Carboplatin Placebo + Paclitaxel + Carboplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    269 / 675 (39.85%)
    104 / 336 (30.95%)
         number of deaths (all causes)
    266
    135
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer stage i
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer stage i
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of pleura
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycosis fungoides
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Paraneoplastic syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial thrombosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Capillary leak syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    6 / 675 (0.89%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         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
    Asthenia
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    6 / 675 (0.89%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    3 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    7 / 675 (1.04%)
    3 / 336 (0.89%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Generalised oedema
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised oedema
         subjects affected / exposed
    7 / 675 (1.04%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    5 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    10 / 675 (1.48%)
    9 / 336 (2.68%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Female genital tract fistula
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal discharge
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoeic attack
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    7 / 675 (1.04%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         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 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    24 / 675 (3.56%)
    3 / 336 (0.89%)
         occurrences causally related to treatment / all
    10 / 28
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    10 / 675 (1.48%)
    3 / 336 (0.89%)
         occurrences causally related to treatment / all
    4 / 10
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Confusional state
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood culture positive
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood sodium decreased
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Culture urine positive
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric injury
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site thrombosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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 coronary syndrome
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure like phenomena
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    Anaemia
         subjects affected / exposed
    6 / 675 (0.89%)
    4 / 336 (1.19%)
         occurrences causally related to treatment / all
    3 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    14 / 675 (2.07%)
    4 / 336 (1.19%)
         occurrences causally related to treatment / all
    5 / 16
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Leukopenia
         subjects affected / exposed
    6 / 675 (0.89%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    17 / 675 (2.52%)
    15 / 336 (4.46%)
         occurrences causally related to treatment / all
    0 / 18
    2 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    1 / 8
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness unilateral
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Conjunctival oedema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Photopsia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous floaters
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    20 / 675 (2.96%)
    9 / 336 (2.68%)
         occurrences causally related to treatment / all
    1 / 21
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    26 / 675 (3.85%)
    6 / 336 (1.79%)
         occurrences causally related to treatment / all
    14 / 38
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    10 / 675 (1.48%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 675 (1.19%)
    3 / 336 (0.89%)
         occurrences causally related to treatment / all
    2 / 9
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric volvulus
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    10 / 675 (1.48%)
    2 / 336 (0.60%)
         occurrences causally related to treatment / all
    2 / 14
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haematoma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    9 / 675 (1.33%)
    7 / 336 (2.08%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal prolapse
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    9 / 675 (1.33%)
    4 / 336 (1.19%)
         occurrences causally related to treatment / all
    3 / 12
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    12 / 675 (1.78%)
    7 / 336 (2.08%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    13 / 675 (1.93%)
    6 / 336 (1.79%)
         occurrences causally related to treatment / all
    1 / 18
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    12 / 675 (1.78%)
    7 / 336 (2.08%)
         occurrences causally related to treatment / all
    2 / 17
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         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
    Erythema multiforme
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder rupture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective spondylitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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 / 675 (0.15%)
    0 / 336 (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
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 675 (0.74%)
    3 / 336 (0.89%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    6 / 675 (0.89%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 675 (1.19%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    4 / 11
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    6 / 675 (0.89%)
    6 / 336 (1.79%)
         occurrences causally related to treatment / all
    2 / 10
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (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
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Trebananib + Paclitaxel + Carboplatin Placebo + Paclitaxel + Carboplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    664 / 675 (98.37%)
    326 / 336 (97.02%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Breast cancer
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cancer pain
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Malignant ascites
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Malignant pleural effusion
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Neoplasm
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Respiratory papilloma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Skin papilloma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Tumour haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Tumour pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Bloody discharge
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    14 / 675 (2.07%)
    2 / 336 (0.60%)
         occurrences all number
    16
    2
    Diastolic hypertension
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Embolism
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Extremity necrosis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Flushing
         subjects affected / exposed
    21 / 675 (3.11%)
    11 / 336 (3.27%)
         occurrences all number
    27
    11
    Haematoma
         subjects affected / exposed
    5 / 675 (0.74%)
    6 / 336 (1.79%)
         occurrences all number
    5
    7
    Haemorrhage
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Hot flush
         subjects affected / exposed
    41 / 675 (6.07%)
    22 / 336 (6.55%)
         occurrences all number
    60
    26
    Hyperaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hypertension
         subjects affected / exposed
    61 / 675 (9.04%)
    27 / 336 (8.04%)
         occurrences all number
    89
    38
    Hypotension
         subjects affected / exposed
    26 / 675 (3.85%)
    10 / 336 (2.98%)
         occurrences all number
    28
    13
    Jugular vein thrombosis
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Lymphocele
         subjects affected / exposed
    6 / 675 (0.89%)
    6 / 336 (1.79%)
         occurrences all number
    6
    7
    Lymphoedema
         subjects affected / exposed
    79 / 675 (11.70%)
    11 / 336 (3.27%)
         occurrences all number
    130
    17
    Lymphorrhoea
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Microangiopathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    12 / 675 (1.78%)
    4 / 336 (1.19%)
         occurrences all number
    14
    6
    Pallor
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    4
    Peripheral coldness
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Peripheral ischaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Phlebitis
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    8
    1
    Phlebitis superficial
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Thrombophlebitis superficial
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Thrombosis
         subjects affected / exposed
    6 / 675 (0.89%)
    1 / 336 (0.30%)
         occurrences all number
    6
    1
    Varicose vein
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Vascular pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Vascular rupture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Venous thrombosis limb
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    3
    Application site pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Application site rash
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Application site reaction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Asthenia
         subjects affected / exposed
    117 / 675 (17.33%)
    70 / 336 (20.83%)
         occurrences all number
    249
    148
    Axillary pain
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Catheter site bruise
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Catheter site dermatitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Catheter site erosion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Catheter site erythema
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Catheter site extravasation
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Catheter site haematoma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Catheter site inflammation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Catheter site necrosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Catheter site pain
         subjects affected / exposed
    5 / 675 (0.74%)
    5 / 336 (1.49%)
         occurrences all number
    5
    5
    Catheter site rash
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    3
    Catheter site related reaction
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Catheter site ulcer
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Catheter site vesicles
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Chest discomfort
         subjects affected / exposed
    10 / 675 (1.48%)
    4 / 336 (1.19%)
         occurrences all number
    11
    4
    Chest pain
         subjects affected / exposed
    23 / 675 (3.41%)
    19 / 336 (5.65%)
         occurrences all number
    30
    20
    Chills
         subjects affected / exposed
    13 / 675 (1.93%)
    7 / 336 (2.08%)
         occurrences all number
    16
    10
    Complication associated with device
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cyst
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Decreased activity
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Discomfort
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Disease progression
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Early satiety
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Facial pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Extravasation
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Fatigue
         subjects affected / exposed
    302 / 675 (44.74%)
    139 / 336 (41.37%)
         occurrences all number
    671
    293
    Feeling cold
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    2
    Gait disturbance
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    6
    2
    Feeling hot
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    6
    4
    General physical health deterioration
         subjects affected / exposed
    9 / 675 (1.33%)
    2 / 336 (0.60%)
         occurrences all number
    10
    2
    Generalised oedema
         subjects affected / exposed
    85 / 675 (12.59%)
    9 / 336 (2.68%)
         occurrences all number
    123
    11
    Hernia
         subjects affected / exposed
    2 / 675 (0.30%)
    5 / 336 (1.49%)
         occurrences all number
    2
    6
    Impaired healing
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Hyperthermia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Inflammation
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Induration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    22 / 675 (3.26%)
    14 / 336 (4.17%)
         occurrences all number
    28
    17
    Infusion site bruising
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Infusion site erythema
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Infusion site oedema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Infusion site pain
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    3
    Infusion site pruritus
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Infusion site reaction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Injection site bruising
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Injection site extravasation
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Injection site pain
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Injection site phlebitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Injection site reaction
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Localised oedema
         subjects affected / exposed
    367 / 675 (54.37%)
    86 / 336 (25.60%)
         occurrences all number
    855
    132
    Malaise
         subjects affected / exposed
    13 / 675 (1.93%)
    11 / 336 (3.27%)
         occurrences all number
    13
    14
    Mass
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Mucosal dryness
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Mucosal inflammation
         subjects affected / exposed
    33 / 675 (4.89%)
    11 / 336 (3.27%)
         occurrences all number
    47
    14
    Mucous membrane disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Non-cardiac chest pain
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    6
    3
    Pain
         subjects affected / exposed
    73 / 675 (10.81%)
    33 / 336 (9.82%)
         occurrences all number
    94
    45
    Peripheral swelling
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Polyp
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    65 / 675 (9.63%)
    40 / 336 (11.90%)
         occurrences all number
    75
    54
    Sensation of foreign body
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Suprapubic pain
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Swelling
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Temperature intolerance
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Tenderness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Thirst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Thirst decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Vascular complication associated with device
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Anaphylactic reaction
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    12 / 675 (1.78%)
    14 / 336 (4.17%)
         occurrences all number
    15
    16
    Cytokine release syndrome
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Food allergy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hypersensitivity
         subjects affected / exposed
    40 / 675 (5.93%)
    16 / 336 (4.76%)
         occurrences all number
    49
    19
    Seasonal allergy
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    3
    Sarcoidosis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Social circumstances
    Menopause
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Bartholin's cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Bleeding anovulatory
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Breast cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Breast disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Breast hyperplasia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Breast mass
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Breast pain
         subjects affected / exposed
    5 / 675 (0.74%)
    3 / 336 (0.89%)
         occurrences all number
    7
    3
    Breast tenderness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cervical dysplasia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cervix disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Cervix erythema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cystocele
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Dyspareunia
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Female genital tract fistula
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Galactorrhoea
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Genital discharge
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Genital pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Genital rash
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Menopausal symptoms
         subjects affected / exposed
    0 / 675 (0.00%)
    4 / 336 (1.19%)
         occurrences all number
    0
    4
    Menorrhagia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Metrorrhagia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pelvic discomfort
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pelvic fluid collection
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Pelvic pain
         subjects affected / exposed
    10 / 675 (1.48%)
    6 / 336 (1.79%)
         occurrences all number
    11
    7
    Perineal ulceration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pruritus genital
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Retracted nipple
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Vaginal discharge
         subjects affected / exposed
    11 / 675 (1.63%)
    6 / 336 (1.79%)
         occurrences all number
    13
    6
    Vaginal haemorrhage
         subjects affected / exposed
    8 / 675 (1.19%)
    9 / 336 (2.68%)
         occurrences all number
    8
    9
    Vaginal inflammation
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Vaginal odour
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Vulva cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Vulvovaginal dryness
         subjects affected / exposed
    5 / 675 (0.74%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Vulvovaginal pruritus
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Respiratory, thoracic and mediastinal disorders
    Acquired diaphragmatic eventration
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Anoxia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Aspiration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Asthma
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Atelectasis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Catarrh
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    7
    3
    Cough
         subjects affected / exposed
    99 / 675 (14.67%)
    49 / 336 (14.58%)
         occurrences all number
    125
    63
    Cough decreased
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Dry throat
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Dysphonia
         subjects affected / exposed
    6 / 675 (0.89%)
    7 / 336 (2.08%)
         occurrences all number
    6
    8
    Dyspnoea
         subjects affected / exposed
    115 / 675 (17.04%)
    39 / 336 (11.61%)
         occurrences all number
    166
    49
    Dyspnoea at rest
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    35 / 675 (5.19%)
    12 / 336 (3.57%)
         occurrences all number
    43
    14
    Emphysema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    23 / 675 (3.41%)
    16 / 336 (4.76%)
         occurrences all number
    24
    18
    Haemoptysis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hiccups
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hydrothorax
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hyperventilation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Increased bronchial secretion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Increased upper airway secretion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Laryngeal inflammation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    2
    Laryngeal pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lung infiltration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    13 / 675 (1.93%)
    5 / 336 (1.49%)
         occurrences all number
    22
    8
    Nasal discomfort
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Nasal dryness
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Nasal mucosal disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Nasal ulcer
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Oropharyngeal discomfort
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    44 / 675 (6.52%)
    22 / 336 (6.55%)
         occurrences all number
    49
    28
    Paranasal sinus hypersecretion
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Pleural disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pleural effusion
         subjects affected / exposed
    59 / 675 (8.74%)
    7 / 336 (2.08%)
         occurrences all number
    76
    9
    Pleuritic pain
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    3
    Pneumothorax
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Productive cough
         subjects affected / exposed
    15 / 675 (2.22%)
    8 / 336 (2.38%)
         occurrences all number
    16
    8
    Pulmonary congestion
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 675 (0.15%)
    4 / 336 (1.19%)
         occurrences all number
    1
    4
    Pulmonary hypertension
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Rales
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Reflux laryngitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Respiratory depression
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Respiratory tract congestion
         subjects affected / exposed
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences all number
    3
    2
    Rhinitis allergic
         subjects affected / exposed
    13 / 675 (1.93%)
    3 / 336 (0.89%)
         occurrences all number
    16
    3
    Rhinitis perennial
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    30 / 675 (4.44%)
    8 / 336 (2.38%)
         occurrences all number
    31
    9
    Sinus congestion
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    6
    2
    Sinus disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Sinusitis noninfective
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Sinus pain
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Sneezing
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Sputum discoloured
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Throat irritation
         subjects affected / exposed
    7 / 675 (1.04%)
    0 / 336 (0.00%)
         occurrences all number
    8
    0
    Tachypnoea
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    8 / 675 (1.19%)
    5 / 336 (1.49%)
         occurrences all number
    8
    6
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Affect lability
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Agitation
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    3
    Anxiety
         subjects affected / exposed
    50 / 675 (7.41%)
    31 / 336 (9.23%)
         occurrences all number
    56
    40
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Apathy
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    2
    Confusional state
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Delirium
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Depressed mood
         subjects affected / exposed
    6 / 675 (0.89%)
    6 / 336 (1.79%)
         occurrences all number
    6
    6
    Depression
         subjects affected / exposed
    35 / 675 (5.19%)
    20 / 336 (5.95%)
         occurrences all number
    42
    26
    Fear
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hallucination
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Illusion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    103 / 675 (15.26%)
    55 / 336 (16.37%)
         occurrences all number
    137
    76
    Insomnia related to another mental condition
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Irritability
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Libido decreased
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Major depression
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Mental disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Mental status changes
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Mood altered
         subjects affected / exposed
    2 / 675 (0.30%)
    3 / 336 (0.89%)
         occurrences all number
    2
    5
    Mood swings
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Nervousness
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Panic attack
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    6
    5
    Sleep disorder
         subjects affected / exposed
    2 / 675 (0.30%)
    5 / 336 (1.49%)
         occurrences all number
    2
    6
    Stress
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Suicidal ideation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Tearfulness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Product issues
    Device failure
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Device issue
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Device occlusion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Thrombosis in device
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hepatic function abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Hepatic pain
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hepatic vein thrombosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hepatotoxicity
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    5 / 675 (0.74%)
    1 / 336 (0.30%)
         occurrences all number
    6
    2
    Hypertransaminasaemia
         subjects affected / exposed
    3 / 675 (0.44%)
    5 / 336 (1.49%)
         occurrences all number
    4
    12
    Investigations
    Activated partial thromboplastin time abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    31 / 675 (4.59%)
    20 / 336 (5.95%)
         occurrences all number
    68
    27
    Amylase increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    22 / 675 (3.26%)
    15 / 336 (4.46%)
         occurrences all number
    43
    21
    Bacterial test
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Bilirubin conjugated increased
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Bleeding time prolonged
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Blood albumin abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood albumin decreased
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    13 / 675 (1.93%)
    10 / 336 (2.98%)
         occurrences all number
    14
    12
    Blood bilirubin increased
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    7
    0
    Blood calcium decreased
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Blood cholesterol increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood creatine increased
         subjects affected / exposed
    4 / 675 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    4
    6
    Blood creatinine abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    19 / 675 (2.81%)
    6 / 336 (1.79%)
         occurrences all number
    32
    8
    Blood gases abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    2 / 675 (0.30%)
    3 / 336 (0.89%)
         occurrences all number
    2
    6
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood lactic acid increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood magnesium decreased
         subjects affected / exposed
    10 / 675 (1.48%)
    7 / 336 (2.08%)
         occurrences all number
    12
    9
    Blood magnesium increased
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Blood parathyroid hormone increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood phosphorus increased
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Blood potassium decreased
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Blood pressure decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood pressure increased
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    9
    1
    Blood sodium decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Blood sodium increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood urea increased
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Blood uric acid abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood urine present
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    C-reactive protein abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    C-reactive protein decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    C-reactive protein increased
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    2
    Cardiac murmur
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Culture urine positive
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Echocardiogram abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Electrocardiogram t wave abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Fibrin d dimer increased
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    10
    2
    Glomerular filtration rate decreased
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    2
    Glucose urine
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Granulocyte count decreased
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    12
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin
         subjects affected / exposed
    8 / 675 (1.19%)
    1 / 336 (0.30%)
         occurrences all number
    24
    3
    Haemoglobin abnormal
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Haemoglobin decreased
         subjects affected / exposed
    31 / 675 (4.59%)
    9 / 336 (2.68%)
         occurrences all number
    73
    18
    Heart rate decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Heart rate increased
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Heart rate irregular
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Hypophonesis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Intraocular pressure increased
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Liver function test
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Liver function test increased
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    7
    6
    Nerve conduction studies abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Neutrophil count abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    46 / 675 (6.81%)
    21 / 336 (6.25%)
         occurrences all number
    121
    73
    Neutrophil count increased
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Nitrite urine present
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pain assessment
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    3
    Platelet count decreased
         subjects affected / exposed
    84 / 675 (12.44%)
    34 / 336 (10.12%)
         occurrences all number
    263
    86
    Platelet count increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Protein total
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Protein total abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Protein total decreased
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Protein urine
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pulmonary physical examination abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Red blood cell count decreased
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Serum ferritin decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Urine analysis abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    3
    Urine output decreased
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Urine output increased
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Urine protein, quantitative
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Vitamin d decreased
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Waist circumference increased
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    28 / 675 (4.15%)
    19 / 336 (5.65%)
         occurrences all number
    52
    41
    Weight increased
         subjects affected / exposed
    46 / 675 (6.81%)
    19 / 336 (5.65%)
         occurrences all number
    107
    27
    White blood cell analysis abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    White blood cell count
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    White blood cell count abnormal
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    White blood cell count decreased
         subjects affected / exposed
    48 / 675 (7.11%)
    19 / 336 (5.65%)
         occurrences all number
    199
    87
    White blood cell count increased
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    White blood cells urine positive
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Animal scratch
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Arthropod bite
         subjects affected / exposed
    1 / 675 (0.15%)
    4 / 336 (1.19%)
         occurrences all number
    1
    4
    Ankle fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Arthropod sting
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Chest crushing
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    16 / 675 (2.37%)
    11 / 336 (3.27%)
         occurrences all number
    23
    14
    Contrast media reaction
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Epicondylitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Craniocerebral injury
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Eye injury
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Excoriation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    7 / 675 (1.04%)
    1 / 336 (0.30%)
         occurrences all number
    12
    2
    Foot fracture
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Foreign body
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Gastrointestinal disorder postoperative
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Haematuria traumatic
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Hip fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Humerus fracture
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Incision site erythema
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Incision site oedema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Incision site pain
         subjects affected / exposed
    7 / 675 (1.04%)
    2 / 336 (0.60%)
         occurrences all number
    9
    2
    Incisional hernia, obstructive
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Infusion related reaction
         subjects affected / exposed
    21 / 675 (3.11%)
    8 / 336 (2.38%)
         occurrences all number
    25
    9
    Injury
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Laceration
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Ligament injury
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Limb injury
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Meniscus injury
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Muscle strain
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Nerve injury
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Post procedural complication
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    6
    2
    Post procedural haematoma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Postoperative fever
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Postoperative hernia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Postoperative ileus
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Postoperative wound complication
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Procedural dizziness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Procedural hypotension
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Procedural nausea
         subjects affected / exposed
    10 / 675 (1.48%)
    5 / 336 (1.49%)
         occurrences all number
    11
    5
    Procedural pain
         subjects affected / exposed
    43 / 675 (6.37%)
    22 / 336 (6.55%)
         occurrences all number
    46
    22
    Rib fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Seroma
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    3
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Stoma site inflammation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Stoma site irritation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Stoma site reaction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Upper limb fracture
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Venous injury
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    6
    2
    Wound complication
         subjects affected / exposed
    11 / 675 (1.63%)
    7 / 336 (2.08%)
         occurrences all number
    12
    7
    Wound decomposition
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Wound dehiscence
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Wound evisceration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Wound haemorrhage
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Wound secretion
         subjects affected / exposed
    2 / 675 (0.30%)
    3 / 336 (0.89%)
         occurrences all number
    2
    3
    Wrist fracture
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Bronchogenic cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Familial tremor
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Arrhythmia
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    3
    Arrhythmia supraventricular
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Atrial flutter
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Atrial tachycardia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular block
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    2
    Bradycardia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Bundle branch block left
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Cardiac failure
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Cardiac failure chronic
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Cardiac flutter
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cardiomegaly
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Cardiovascular disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Myocardial ischaemia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Nodal arrhythmia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Palpitations
         subjects affected / exposed
    20 / 675 (2.96%)
    16 / 336 (4.76%)
         occurrences all number
    23
    17
    Pericardial effusion
         subjects affected / exposed
    5 / 675 (0.74%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Sinus tachycardia
         subjects affected / exposed
    7 / 675 (1.04%)
    3 / 336 (0.89%)
         occurrences all number
    7
    3
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    13 / 675 (1.93%)
    10 / 336 (2.98%)
         occurrences all number
    13
    11
    Tachycardia foetal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Ventricular flutter
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    5 / 675 (0.74%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Anosmia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Aphasia
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Aphonia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Ataxia
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Aura
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    3 / 675 (0.44%)
    4 / 336 (1.19%)
         occurrences all number
    3
    5
    Burning sensation
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    3
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Cognitive disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    4 / 336 (1.19%)
         occurrences all number
    0
    4
    Cranial nerve disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    2
    Depressed level of consciousness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Diabetic neuropathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Disturbance in attention
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Dizziness
         subjects affected / exposed
    128 / 675 (18.96%)
    48 / 336 (14.29%)
         occurrences all number
    211
    68
    Dizziness exertional
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Dizziness postural
         subjects affected / exposed
    7 / 675 (1.04%)
    1 / 336 (0.30%)
         occurrences all number
    10
    1
    Dysaesthesia
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    5
    4
    Dysarthria
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    71 / 675 (10.52%)
    37 / 336 (11.01%)
         occurrences all number
    84
    50
    Dyskinesia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Facial paralysis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Head discomfort
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    121 / 675 (17.93%)
    51 / 336 (15.18%)
         occurrences all number
    182
    90
    Horner's syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Hyperaesthesia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Hypoaesthesia
         subjects affected / exposed
    24 / 675 (3.56%)
    10 / 336 (2.98%)
         occurrences all number
    33
    12
    Lethargy
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Memory impairment
         subjects affected / exposed
    7 / 675 (1.04%)
    6 / 336 (1.79%)
         occurrences all number
    7
    6
    Mental impairment
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Meralgia paraesthetica
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Migraine
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Migraine with aura
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Motor dysfunction
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Myoclonus
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Nervous system disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Neuralgia
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    11
    0
    Neuropathy peripheral
         subjects affected / exposed
    215 / 675 (31.85%)
    103 / 336 (30.65%)
         occurrences all number
    363
    173
    Neurotoxicity
         subjects affected / exposed
    19 / 675 (2.81%)
    12 / 336 (3.57%)
         occurrences all number
    30
    23
    Olfactory nerve disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    74 / 675 (10.96%)
    41 / 336 (12.20%)
         occurrences all number
    101
    66
    Parosmia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Peripheral motor neuropathy
         subjects affected / exposed
    7 / 675 (1.04%)
    2 / 336 (0.60%)
         occurrences all number
    8
    2
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    139 / 675 (20.59%)
    65 / 336 (19.35%)
         occurrences all number
    208
    111
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Polyneuropathy
         subjects affected / exposed
    22 / 675 (3.26%)
    16 / 336 (4.76%)
         occurrences all number
    28
    27
    Poor quality sleep
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Post herpetic neuralgia
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Post-traumatic headache
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Radicular pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    13 / 675 (1.93%)
    9 / 336 (2.68%)
         occurrences all number
    15
    10
    Reversed hot-cold sensation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    5 / 675 (0.74%)
    4 / 336 (1.19%)
         occurrences all number
    11
    5
    Seizure
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Sensory disturbance
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Sinus headache
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    8 / 675 (1.19%)
    5 / 336 (1.49%)
         occurrences all number
    8
    6
    Speech disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Syncope
         subjects affected / exposed
    18 / 675 (2.67%)
    10 / 336 (2.98%)
         occurrences all number
    22
    10
    Tension headache
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Thoracic outlet syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Toxic neuropathy
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    3
    Tremor
         subjects affected / exposed
    11 / 675 (1.63%)
    5 / 336 (1.49%)
         occurrences all number
    12
    7
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    201 / 675 (29.78%)
    112 / 336 (33.33%)
         occurrences all number
    556
    306
    Anaemia vitamin b12 deficiency
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Coagulopathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Febrile neutropenia
         subjects affected / exposed
    5 / 675 (0.74%)
    2 / 336 (0.60%)
         occurrences all number
    5
    2
    Haematotoxicity
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hypercoagulation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hypochromasia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Increased tendency to bruise
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Leukocytosis
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Leukopenia
         subjects affected / exposed
    116 / 675 (17.19%)
    58 / 336 (17.26%)
         occurrences all number
    466
    205
    Lymph node pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lymphadenitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Lymphopenia
         subjects affected / exposed
    9 / 675 (1.33%)
    4 / 336 (1.19%)
         occurrences all number
    43
    12
    Neutropenia
         subjects affected / exposed
    296 / 675 (43.85%)
    157 / 336 (46.73%)
         occurrences all number
    1104
    532
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pancytopenia
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    4
    7
    Platelet disorder
         subjects affected / exposed
    6 / 675 (0.89%)
    3 / 336 (0.89%)
         occurrences all number
    6
    8
    Thrombasthenia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    131 / 675 (19.41%)
    59 / 336 (17.56%)
         occurrences all number
    340
    160
    Thrombocytosis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    White blood cell disorder
         subjects affected / exposed
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences all number
    12
    2
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Conductive deafness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Deafness
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    6
    4
    Deafness bilateral
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Deafness unilateral
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Ear congestion
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Ear discomfort
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Ear disorder
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Ear pain
         subjects affected / exposed
    13 / 675 (1.93%)
    6 / 336 (1.79%)
         occurrences all number
    17
    7
    Eustachian tube dysfunction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Eustachian tube patulous
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hypoacusis
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Motion sickness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Ototoxicity
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    26 / 675 (3.85%)
    6 / 336 (1.79%)
         occurrences all number
    28
    9
    Vertigo
         subjects affected / exposed
    21 / 675 (3.11%)
    4 / 336 (1.19%)
         occurrences all number
    25
    8
    Vertigo positional
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Amblyopia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Asthenopia
         subjects affected / exposed
    0 / 675 (0.00%)
    3 / 336 (0.89%)
         occurrences all number
    0
    3
    Blepharospasm
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cataract
         subjects affected / exposed
    5 / 675 (0.74%)
    2 / 336 (0.60%)
         occurrences all number
    6
    2
    Chalazion
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    3
    Conjunctival oedema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Diplopia
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Dry eye
         subjects affected / exposed
    24 / 675 (3.56%)
    9 / 336 (2.68%)
         occurrences all number
    30
    9
    Eye allergy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Eye discharge
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Eye disorder
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Eye haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Eye irritation
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    4
    Eye movement disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    2
    Eye pain
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Eye pruritus
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Eyelid irritation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Eyelid ptosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Glaucoma
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Hypermetropia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lacrimation increased
         subjects affected / exposed
    19 / 675 (2.81%)
    2 / 336 (0.60%)
         occurrences all number
    21
    2
    Maculopathy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Ocular discomfort
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Ocular hypertension
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Photophobia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Photopsia
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Presbyopia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Pterygium
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Punctate keratitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Scleral cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Scleral disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Scleral haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    74 / 675 (10.96%)
    24 / 336 (7.14%)
         occurrences all number
    85
    30
    Visual acuity reduced
         subjects affected / exposed
    7 / 675 (1.04%)
    1 / 336 (0.30%)
         occurrences all number
    8
    1
    Vitreous detachment
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Visual impairment
         subjects affected / exposed
    7 / 675 (1.04%)
    4 / 336 (1.19%)
         occurrences all number
    9
    4
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Vitreous floaters
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    18 / 675 (2.67%)
    11 / 336 (3.27%)
         occurrences all number
    20
    11
    Abdominal distension
         subjects affected / exposed
    71 / 675 (10.52%)
    25 / 336 (7.44%)
         occurrences all number
    95
    27
    Abdominal hernia
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain
         subjects affected / exposed
    212 / 675 (31.41%)
    109 / 336 (32.44%)
         occurrences all number
    372
    179
    Abdominal pain lower
         subjects affected / exposed
    26 / 675 (3.85%)
    10 / 336 (2.98%)
         occurrences all number
    31
    11
    Abdominal pain upper
         subjects affected / exposed
    72 / 675 (10.67%)
    35 / 336 (10.42%)
         occurrences all number
    102
    47
    Abdominal rigidity
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Abdominal tenderness
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Anal fissure
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Anal incontinence
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Anal haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Anal pruritus
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Anal sphincter atony
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Anal ulcer
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Anorectal discomfort
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Aphthous ulcer
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    7
    6
    Ascites
         subjects affected / exposed
    91 / 675 (13.48%)
    21 / 336 (6.25%)
         occurrences all number
    172
    29
    Bowel movement irregularity
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Change of bowel habit
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Chapped lips
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Colitis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Cheilitis
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Constipation
         subjects affected / exposed
    267 / 675 (39.56%)
    143 / 336 (42.56%)
         occurrences all number
    397
    207
    Defaecation urgency
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Dental caries
         subjects affected / exposed
    3 / 675 (0.44%)
    5 / 336 (1.49%)
         occurrences all number
    3
    5
    Diarrhoea
         subjects affected / exposed
    238 / 675 (35.26%)
    116 / 336 (34.52%)
         occurrences all number
    423
    203
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Douglas' pouch mass
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    24 / 675 (3.56%)
    11 / 336 (3.27%)
         occurrences all number
    27
    12
    Dyschezia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    78 / 675 (11.56%)
    33 / 336 (9.82%)
         occurrences all number
    96
    38
    Dysphagia
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Enteritis
         subjects affected / exposed
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Enterocolitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    7 / 675 (1.04%)
    5 / 336 (1.49%)
         occurrences all number
    9
    5
    Eructation
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Faecaloma
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Faeces soft
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    3
    Flatulence
         subjects affected / exposed
    26 / 675 (3.85%)
    9 / 336 (2.68%)
         occurrences all number
    30
    10
    Food poisoning
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Frequent bowel movements
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Gastric disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Gastric ulcer
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Gastritis
         subjects affected / exposed
    7 / 675 (1.04%)
    5 / 336 (1.49%)
         occurrences all number
    8
    5
    Gastritis erosive
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Gastrointestinal disorder
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Gastrointestinal motility disorder
         subjects affected / exposed
    2 / 675 (0.30%)
    3 / 336 (0.89%)
         occurrences all number
    2
    3
    Gastrointestinal obstruction
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Gastrointestinal pain
         subjects affected / exposed
    6 / 675 (0.89%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    22 / 675 (3.26%)
    9 / 336 (2.68%)
         occurrences all number
    24
    10
    Gingival bleeding
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    4
    Gingival pain
         subjects affected / exposed
    6 / 675 (0.89%)
    1 / 336 (0.30%)
         occurrences all number
    6
    1
    Gingival swelling
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    5 / 675 (0.74%)
    3 / 336 (0.89%)
         occurrences all number
    5
    3
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Haemorrhoids
         subjects affected / exposed
    19 / 675 (2.81%)
    5 / 336 (1.49%)
         occurrences all number
    23
    5
    Hiatus hernia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hyperchlorhydria
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Ileus
         subjects affected / exposed
    8 / 675 (1.19%)
    2 / 336 (0.60%)
         occurrences all number
    9
    3
    Inguinal hernia
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Intestinal fistula
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Intestinal obstruction
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Large intestinal obstruction
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Large intestine perforation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Lip blister
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Lip pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Lip ulceration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Melaena
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Mouth haemorrhage
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Nausea
         subjects affected / exposed
    387 / 675 (57.33%)
    205 / 336 (61.01%)
         occurrences all number
    835
    375
    Odynophagia
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    6
    Oesophageal pain
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Oesophageal spasm
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    4 / 675 (0.59%)
    3 / 336 (0.89%)
         occurrences all number
    4
    3
    Oral disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Oral mucosal erythema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Oral mucosal exfoliation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Oral pain
         subjects affected / exposed
    4 / 675 (0.59%)
    6 / 336 (1.79%)
         occurrences all number
    4
    7
    Pancreatitis chronic
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Parotid duct obstruction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Perianal erythema
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Periodontal disease
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Proctalgia
         subjects affected / exposed
    4 / 675 (0.59%)
    3 / 336 (0.89%)
         occurrences all number
    4
    3
    Rectal discharge
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Rectal fissure
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    6 / 675 (0.89%)
    4 / 336 (1.19%)
         occurrences all number
    8
    5
    Retching
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Salivary gland pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Sensitivity of teeth
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    2
    Small intestinal obstruction
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Stomatitis
         subjects affected / exposed
    41 / 675 (6.07%)
    21 / 336 (6.25%)
         occurrences all number
    50
    21
    Subileus
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Tongue coated
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Tongue discolouration
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    2
    Tooth disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Tooth loss
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    22 / 675 (3.26%)
    11 / 336 (3.27%)
         occurrences all number
    25
    12
    Umbilical hernia
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    3
    Vomiting
         subjects affected / exposed
    233 / 675 (34.52%)
    109 / 336 (32.44%)
         occurrences all number
    383
    176
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    363 / 675 (53.78%)
    179 / 336 (53.27%)
         occurrences all number
    507
    257
    Acne
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    7
    1
    Alopecia totalis
         subjects affected / exposed
    1 / 675 (0.15%)
    4 / 336 (1.19%)
         occurrences all number
    1
    4
    Alopecia areata
         subjects affected / exposed
    2 / 675 (0.30%)
    6 / 336 (1.79%)
         occurrences all number
    2
    9
    Blister
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Dermal cyst
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Dermatitis
         subjects affected / exposed
    6 / 675 (0.89%)
    3 / 336 (0.89%)
         occurrences all number
    6
    4
    Dermatitis acneiform
         subjects affected / exposed
    9 / 675 (1.33%)
    4 / 336 (1.19%)
         occurrences all number
    11
    6
    Dermatitis allergic
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    3
    Dermatitis bullous
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Diabetic foot
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Dry skin
         subjects affected / exposed
    24 / 675 (3.56%)
    15 / 336 (4.46%)
         occurrences all number
    27
    15
    Ecchymosis
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Eczema
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Erythema
         subjects affected / exposed
    24 / 675 (3.56%)
    13 / 336 (3.87%)
         occurrences all number
    33
    15
    Erythema multiforme
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Exfoliative rash
         subjects affected / exposed
    7 / 675 (1.04%)
    0 / 336 (0.00%)
         occurrences all number
    9
    0
    Excessive granulation tissue
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hair growth abnormal
         subjects affected / exposed
    5 / 675 (0.74%)
    3 / 336 (0.89%)
         occurrences all number
    6
    3
    Hidradenitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    7 / 675 (1.04%)
    8 / 336 (2.38%)
         occurrences all number
    8
    9
    Hirsutism
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hyperkeratosis
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Ingrowing nail
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Lichen sclerosus
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Madarosis
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Nail bed inflammation
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Nail discolouration
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    3
    3
    Nail disorder
         subjects affected / exposed
    17 / 675 (2.52%)
    7 / 336 (2.08%)
         occurrences all number
    21
    7
    Nail dystrophy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Night sweats
         subjects affected / exposed
    11 / 675 (1.63%)
    3 / 336 (0.89%)
         occurrences all number
    12
    3
    Onychoclasis
         subjects affected / exposed
    1 / 675 (0.15%)
    6 / 336 (1.79%)
         occurrences all number
    1
    6
    Onychomadesis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Pain of skin
         subjects affected / exposed
    2 / 675 (0.30%)
    3 / 336 (0.89%)
         occurrences all number
    2
    3
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    5 / 675 (0.74%)
    2 / 336 (0.60%)
         occurrences all number
    5
    2
    Panniculitis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Papule
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Petechiae
         subjects affected / exposed
    4 / 675 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    4
    4
    Photosensitivity reaction
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Piloerection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Pityriasis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    69 / 675 (10.22%)
    29 / 336 (8.63%)
         occurrences all number
    84
    41
    Pruritus allergic
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Pruritus generalised
         subjects affected / exposed
    4 / 675 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    4
    4
    Psoriasis
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Purpura
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    2
    Rash
         subjects affected / exposed
    77 / 675 (11.41%)
    49 / 336 (14.58%)
         occurrences all number
    101
    66
    Rash erythematous
         subjects affected / exposed
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences all number
    4
    4
    Rash generalised
         subjects affected / exposed
    0 / 675 (0.00%)
    4 / 336 (1.19%)
         occurrences all number
    0
    4
    Rash macular
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Rash maculo-papular
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    4
    2
    Rash papular
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    5
    Rash pruritic
         subjects affected / exposed
    12 / 675 (1.78%)
    5 / 336 (1.49%)
         occurrences all number
    15
    5
    Rash vesicular
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Rosacea
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Scab
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Scar pain
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Skin atrophy
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Skin depigmentation
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Skin discolouration
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Skin disorder
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Skin exfoliation
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Skin fissures
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Skin hyperpigmentation
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    3
    3
    Skin irritation
         subjects affected / exposed
    0 / 675 (0.00%)
    3 / 336 (0.89%)
         occurrences all number
    0
    4
    Skin lesion
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    3
    3
    Skin mass
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Skin reaction
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Skin tightness
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Skin toxicity
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Skin ulcer
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    8
    0
    Stasis dermatitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Sweat gland disorder
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Swelling face
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Telangiectasia
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    2
    Toxic skin eruption
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Umbilical discharge
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    18 / 675 (2.67%)
    12 / 336 (3.57%)
         occurrences all number
    21
    14
    Urticaria aquagenic
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Xeroderma
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Albuminuria
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Bladder pain
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Bladder prolapse
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Bladder spasm
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Calculus urinary
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Cystitis noninfective
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Cystitis-like symptom
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Dysuria
         subjects affected / exposed
    29 / 675 (4.30%)
    15 / 336 (4.46%)
         occurrences all number
    37
    18
    Glycosuria
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Haematuria
         subjects affected / exposed
    6 / 675 (0.89%)
    2 / 336 (0.60%)
         occurrences all number
    6
    2
    Hydronephrosis
         subjects affected / exposed
    7 / 675 (1.04%)
    0 / 336 (0.00%)
         occurrences all number
    7
    0
    Incontinence
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Micturition disorder
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Micturition urgency
         subjects affected / exposed
    7 / 675 (1.04%)
    4 / 336 (1.19%)
         occurrences all number
    7
    4
    Nephrolithiasis
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    3
    Neurogenic bladder
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Oliguria
         subjects affected / exposed
    5 / 675 (0.74%)
    1 / 336 (0.30%)
         occurrences all number
    5
    1
    Pollakiuria
         subjects affected / exposed
    18 / 675 (2.67%)
    10 / 336 (2.98%)
         occurrences all number
    19
    10
    Polyuria
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Proteinuria
         subjects affected / exposed
    21 / 675 (3.11%)
    9 / 336 (2.68%)
         occurrences all number
    28
    11
    Pyelocaliectasis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Renal aneurysm
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Renal colic
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Renal failure
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Renal impairment
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Renal pain
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Renal vein thrombosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Stress urinary incontinence
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Urethral pain
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Urge incontinence
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Urinary bladder rupture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    16 / 675 (2.37%)
    12 / 336 (3.57%)
         occurrences all number
    20
    15
    Urinary retention
         subjects affected / exposed
    6 / 675 (0.89%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Urinary tract disorder
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Urinary tract pain
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Urine abnormality
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Goitre
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hypothyroidism
         subjects affected / exposed
    4 / 675 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    4
    4
    Thyroid cyst
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Thyroid mass
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    189 / 675 (28.00%)
    92 / 336 (27.38%)
         occurrences all number
    380
    173
    Arthritis
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Back pain
         subjects affected / exposed
    90 / 675 (13.33%)
    59 / 336 (17.56%)
         occurrences all number
    124
    77
    Bone cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Bone loss
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Bone pain
         subjects affected / exposed
    51 / 675 (7.56%)
    30 / 336 (8.93%)
         occurrences all number
    66
    43
    Bursitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Coccydynia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Costochondritis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Exostosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Fistula
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Flank pain
         subjects affected / exposed
    13 / 675 (1.93%)
    4 / 336 (1.19%)
         occurrences all number
    15
    4
    Fracture pain
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    12 / 675 (1.78%)
    3 / 336 (0.89%)
         occurrences all number
    15
    3
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Joint effusion
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Joint stiffness
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    3
    3
    Joint swelling
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Limb discomfort
         subjects affected / exposed
    6 / 675 (0.89%)
    6 / 336 (1.79%)
         occurrences all number
    7
    10
    Muscle contracture
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Muscle fatigue
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Muscle rigidity
         subjects affected / exposed
    0 / 675 (0.00%)
    2 / 336 (0.60%)
         occurrences all number
    0
    2
    Muscle spasms
         subjects affected / exposed
    21 / 675 (3.11%)
    19 / 336 (5.65%)
         occurrences all number
    24
    23
    Muscle tightness
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    33 / 675 (4.89%)
    17 / 336 (5.06%)
         occurrences all number
    41
    21
    Musculoskeletal chest pain
         subjects affected / exposed
    12 / 675 (1.78%)
    8 / 336 (2.38%)
         occurrences all number
    13
    8
    Musculoskeletal discomfort
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    38 / 675 (5.63%)
    35 / 336 (10.42%)
         occurrences all number
    47
    50
    Musculoskeletal stiffness
         subjects affected / exposed
    4 / 675 (0.59%)
    3 / 336 (0.89%)
         occurrences all number
    5
    5
    Myalgia
         subjects affected / exposed
    125 / 675 (18.52%)
    64 / 336 (19.05%)
         occurrences all number
    219
    117
    Myopathy
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Myositis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Neck mass
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    10 / 675 (1.48%)
    7 / 336 (2.08%)
         occurrences all number
    10
    8
    Osteoarthritis
         subjects affected / exposed
    3 / 675 (0.44%)
    4 / 336 (1.19%)
         occurrences all number
    3
    4
    Osteomalacia
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    2
    3
    Osteopenia
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Osteoporosis
         subjects affected / exposed
    1 / 675 (0.15%)
    3 / 336 (0.89%)
         occurrences all number
    1
    3
    Pain in extremity
         subjects affected / exposed
    118 / 675 (17.48%)
    45 / 336 (13.39%)
         occurrences all number
    186
    59
    Pain in jaw
         subjects affected / exposed
    8 / 675 (1.19%)
    5 / 336 (1.49%)
         occurrences all number
    8
    5
    Periarthritis
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Plantar fasciitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Rib deformity
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Sarcopenia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Sjogren's syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Soft tissue mass
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Soft tissue necrosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Spinal pain
         subjects affected / exposed
    2 / 675 (0.30%)
    3 / 336 (0.89%)
         occurrences all number
    2
    3
    Synovial cyst
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Tendon pain
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Tendonitis
         subjects affected / exposed
    4 / 675 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    4
    4
    Tenosynovitis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Torticollis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Abdominal wall infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Bacteraemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Bacterial infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Bacterial vaginosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Bacteriuria
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Breast abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    10 / 675 (1.48%)
    5 / 336 (1.49%)
         occurrences all number
    11
    5
    Bronchitis viral
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Catheter site cellulitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Candida infection
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Cellulitis
         subjects affected / exposed
    13 / 675 (1.93%)
    2 / 336 (0.60%)
         occurrences all number
    14
    2
    Catheter site infection
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Clostridium colitis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Clostridium difficile infection
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Conjunctivitis
         subjects affected / exposed
    12 / 675 (1.78%)
    6 / 336 (1.79%)
         occurrences all number
    13
    6
    Cystitis
         subjects affected / exposed
    21 / 675 (3.11%)
    6 / 336 (1.79%)
         occurrences all number
    25
    7
    Cystitis bacterial
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Cystitis escherichia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Device related infection
         subjects affected / exposed
    5 / 675 (0.74%)
    3 / 336 (0.89%)
         occurrences all number
    6
    3
    Diarrhoea infectious
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Ear lobe infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Empyema
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Enteritis infectious
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Erysipelas
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Erysipeloid
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Escherichia infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Eye infection
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Folliculitis
         subjects affected / exposed
    2 / 675 (0.30%)
    2 / 336 (0.60%)
         occurrences all number
    2
    2
    Fungal infection
         subjects affected / exposed
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Fungal skin infection
         subjects affected / exposed
    1 / 675 (0.15%)
    2 / 336 (0.60%)
         occurrences all number
    1
    2
    Furuncle
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    7 / 675 (1.04%)
    5 / 336 (1.49%)
         occurrences all number
    8
    5
    Gastroenteritis viral
         subjects affected / exposed
    8 / 675 (1.19%)
    0 / 336 (0.00%)
         occurrences all number
    8
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Genital candidiasis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Genital herpes
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Genitourinary tract infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Gingivitis
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Groin abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Haematoma infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Helicobacter infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hepatitis c
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Herpes dermatitis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Herpes simplex
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Herpes virus infection
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Herpes zoster
         subjects affected / exposed
    8 / 675 (1.19%)
    2 / 336 (0.60%)
         occurrences all number
    10
    2
    Impetigo
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    2
    Hordeolum
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Infected lymphocele
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Incision site infection
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Infection
         subjects affected / exposed
    8 / 675 (1.19%)
    2 / 336 (0.60%)
         occurrences all number
    8
    2
    Infection parasitic
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    18 / 675 (2.67%)
    11 / 336 (3.27%)
         occurrences all number
    19
    12
    Injection site infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Kidney infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    7 / 675 (1.04%)
    2 / 336 (0.60%)
         occurrences all number
    8
    2
    Lip infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Localised infection
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    2
    Lung infection
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Lymphangitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Mastitis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Mucosal infection
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Nail infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    51 / 675 (7.56%)
    31 / 336 (9.23%)
         occurrences all number
    78
    44
    Onychomycosis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Oral candidiasis
         subjects affected / exposed
    3 / 675 (0.44%)
    3 / 336 (0.89%)
         occurrences all number
    3
    3
    Oral fungal infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Osteomyelitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Oral herpes
         subjects affected / exposed
    10 / 675 (1.48%)
    4 / 336 (1.19%)
         occurrences all number
    10
    4
    Paronychia
         subjects affected / exposed
    3 / 675 (0.44%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Pelvic abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Parotitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Peritonitis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Periodontitis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    4 / 675 (0.59%)
    4 / 336 (1.19%)
         occurrences all number
    5
    5
    Pharyngitis bacterial
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    9 / 675 (1.33%)
    1 / 336 (0.30%)
         occurrences all number
    9
    5
    Post procedural cellulitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Post procedural infection
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Postoperative wound infection
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    5
    0
    Pulpitis dental
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    2
    Pyelonephritis acute
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Pyuria
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Rash pustular
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    12 / 675 (1.78%)
    1 / 336 (0.30%)
         occurrences all number
    14
    1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    10 / 675 (1.48%)
    9 / 336 (2.68%)
         occurrences all number
    14
    10
    Sepsis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Sialoadenitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    16 / 675 (2.37%)
    5 / 336 (1.49%)
         occurrences all number
    18
    7
    Skin candida
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    2
    Skin infection
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Staphylococcal scalded skin syndrome
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Stoma site abscess
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Stoma site infection
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Superinfection
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Tinea pedis
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Tooth abscess
         subjects affected / exposed
    10 / 675 (1.48%)
    6 / 336 (1.79%)
         occurrences all number
    14
    7
    Tooth infection
         subjects affected / exposed
    5 / 675 (0.74%)
    2 / 336 (0.60%)
         occurrences all number
    5
    2
    Upper respiratory tract infection
         subjects affected / exposed
    36 / 675 (5.33%)
    11 / 336 (3.27%)
         occurrences all number
    42
    16
    Tracheitis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    7 / 675 (1.04%)
    2 / 336 (0.60%)
         occurrences all number
    8
    2
    Urinary tract infection
         subjects affected / exposed
    85 / 675 (12.59%)
    36 / 336 (10.71%)
         occurrences all number
    135
    52
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Urosepsis
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Vaginal abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    2
    Vaginitis bacterial
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Viral infection
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Viral diarrhoea
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    1
    1
    Wound abscess
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Wound infection
         subjects affected / exposed
    5 / 675 (0.74%)
    0 / 336 (0.00%)
         occurrences all number
    6
    0
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Abnormal loss of weight
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    175 / 675 (25.93%)
    89 / 336 (26.49%)
         occurrences all number
    278
    143
    Dehydration
         subjects affected / exposed
    34 / 675 (5.04%)
    13 / 336 (3.87%)
         occurrences all number
    52
    14
    Diabetes mellitus
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Fluid imbalance
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Fluid retention
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Food craving
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Gout
         subjects affected / exposed
    1 / 675 (0.15%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Hyper hdl cholesterolaemia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    4 / 675 (0.59%)
    1 / 336 (0.30%)
         occurrences all number
    4
    1
    Hypercholesterolaemia
         subjects affected / exposed
    8 / 675 (1.19%)
    1 / 336 (0.30%)
         occurrences all number
    8
    1
    Hyperglycaemia
         subjects affected / exposed
    30 / 675 (4.44%)
    12 / 336 (3.57%)
         occurrences all number
    57
    31
    Hyperkalaemia
         subjects affected / exposed
    11 / 675 (1.63%)
    8 / 336 (2.38%)
         occurrences all number
    33
    8
    Hyperlipidaemia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hypernatraemia
         subjects affected / exposed
    4 / 675 (0.59%)
    0 / 336 (0.00%)
         occurrences all number
    7
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Hypoalbuminaemia
         subjects affected / exposed
    40 / 675 (5.93%)
    9 / 336 (2.68%)
         occurrences all number
    75
    13
    Hypocalcaemia
         subjects affected / exposed
    24 / 675 (3.56%)
    9 / 336 (2.68%)
         occurrences all number
    43
    12
    Hypochloraemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    3 / 675 (0.44%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Hypokalaemia
         subjects affected / exposed
    115 / 675 (17.04%)
    46 / 336 (13.69%)
         occurrences all number
    220
    70
    Hypomagnesaemia
         subjects affected / exposed
    89 / 675 (13.19%)
    41 / 336 (12.20%)
         occurrences all number
    168
    79
    Hypometabolism
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Hyponatraemia
         subjects affected / exposed
    21 / 675 (3.11%)
    12 / 336 (3.57%)
         occurrences all number
    32
    19
    Hypophosphataemia
         subjects affected / exposed
    4 / 675 (0.59%)
    2 / 336 (0.60%)
         occurrences all number
    4
    3
    Hypoproteinaemia
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Hyposideraemia
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Increased appetite
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    4
    0
    Iron deficiency
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Magnesium deficiency
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Malnutrition
         subjects affected / exposed
    3 / 675 (0.44%)
    0 / 336 (0.00%)
         occurrences all number
    3
    0
    Metabolic acidosis
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Polydipsia
         subjects affected / exposed
    2 / 675 (0.30%)
    0 / 336 (0.00%)
         occurrences all number
    2
    0
    Protein deficiency
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    2
    1
    Vitamin b complex deficiency
         subjects affected / exposed
    0 / 675 (0.00%)
    1 / 336 (0.30%)
         occurrences all number
    0
    1
    Vitamin d deficiency
         subjects affected / exposed
    2 / 675 (0.30%)
    1 / 336 (0.30%)
         occurrences all number
    3
    1
    Vitamin k deficiency
         subjects affected / exposed
    1 / 675 (0.15%)
    0 / 336 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2012
    - Amgen documentation regarding the process for determination of expectedness of adverse events for expedited reporting to regulatory agencies globally was amended - The timeline for serious adverse event reporting was changed (within 24 hours) - The Pregnancy and Lactation Reporting section was updated - The reporting of serious adverse events using the electronic serious adverse event report form was clarified
    17 Jan 2014
    - The sample size was reduced from 2000 to 1000 subjects to enhance the feasibility of study completion without compromising the integrity of the primary endpoint of the study - Language on safety data collection, recording, and reporting was updated - Language on how to address and report serious adverse events occurring outside the protocol reporting period was added

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

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

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