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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab plus Docetaxel versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or after Platinum-Based Therapy.

    Summary
    EudraCT number
    		 2014-003655-66
    Trial protocol
    		 ES   HU   DK   DE   NL   PL   GB   BE   GR   IT  
    Global end of trial date
    26 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2023
    First version publication date
    09 Aug 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4T-MC-JVDC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02426125
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15679
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    26 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 10
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    United States: 35
    Country: Number of subjects enrolled
    Japan: 54
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    United Kingdom: 42
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Spain: 37
    Country: Number of subjects enrolled
    Greece: 26
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 25
    Country: Number of subjects enrolled
    Netherlands: 35
    Country: Number of subjects enrolled
    Turkey: 28
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Taiwan: 31
    Country: Number of subjects enrolled
    Denmark: 11
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Italy: 37
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Germany: 16
    Worldwide total number of subjects
    530
    EEA total number of subjects
    234
    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)
    239
    From 65 to 84 years
    289
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Completers include participants who are confirmed to be alive at study completion.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ramucirumab + Docetaxel
    Arm description
    		 Ramucirumab (10 milligram/kilogram [mg/kg]) intravenously (IV) plus docetaxel (75 milligram/square meter [mg/m²]) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ramucirumab
    Investigational medicinal product code
    Other name
    LY3009806
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 10 mg/kg of Ramucirumab intravenously (IV) on day 1 of each 21-day cycle.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 75 mg/m² of docetaxel Intravenously on day 1 of each 21-day cycle.

    Arm title
    		 Placebo + Docetaxel
    Arm description
    		 Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 75 mg/m² of docetaxel intravenously on day 1 of each 21-day cycle.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received matching placebo intravenously on day 1 of each 21-day cycle.

    Number of subjects in period 1
    		Ramucirumab + Docetaxel Placebo + Docetaxel
    Started
    263
    267
    Received at least one dose of study drug
    258
    265
    Completed
    46
    39
    Not completed
    217
    228
         Adverse event, serious fatal
    185
    200
         Consent withdrawn by subject
    13
    14
         Randomized, But Never Treated
    5
    2
         Lost to follow-up
    14
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ramucirumab + Docetaxel
    Reporting group description
    		 Ramucirumab (10 milligram/kilogram [mg/kg]) intravenously (IV) plus docetaxel (75 milligram/square meter [mg/m²]) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Reporting group title
    Placebo + Docetaxel
    Reporting group description
    		 Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Reporting group values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel Total
    Number of subjects
    		 263 267 530
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.6 ± 9.9 64.8 ± 9.2 -
    Gender categorical
    Units: Subjects
        Female
    		 50 52 102
        Male
    		 213 215 428
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 13 10 23
        Not Hispanic or Latino
    		 208 219 427
        Unknown or Not Reported
    		 42 38 80
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 54 61 115
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 3 2 5
        White
    		 203 204 407
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 2 0 2
    Region of Enrollment
    Units: Subjects
        Romania
    		 5 5 10
        Hungary
    		 5 8 13
        United States
    		 17 18 35
        Japan
    		 24 30 54
        Ukraine
    		 5 3 8
        United Kingdom
    		 18 24 42
        Russia
    		 18 12 30
        Spain
    		 22 15 37
        Greece
    		 13 13 26
        Canada
    		 4 5 9
        South Korea
    		 16 9 25
        Netherlands
    		 17 18 35
        Turkey
    		 11 17 28
        Belgium
    		 6 1 7
        Taiwan
    		 13 18 31
        Denmark
    		 5 6 11
        Poland
    		 4 4 8
        Italy
    		 23 14 37
        Mexico
    		 3 1 4
        Israel
    		 7 11 18
        Australia
    		 6 6 12
        France
    		 16 18 34
        Germany
    		 5 11 16

    End points

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    End points reporting groups
    Reporting group title
    Ramucirumab + Docetaxel
    Reporting group description
    		 Ramucirumab (10 milligram/kilogram [mg/kg]) intravenously (IV) plus docetaxel (75 milligram/square meter [mg/m²]) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Reporting group title
    Placebo + Docetaxel
    Reporting group description
    		 Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date. Analysis population description (APD): All randomized participants. Censored participants: Ramucirumab + Docetaxel = 51, Placebo + Docetaxel =31.
    End point type
    Primary
    End point timeframe
    Randomization to Radiological Disease Progression or Death from Any Cause (Up to 29.7 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    263
    267
    Units: Months
        median (confidence interval 95%)
    4.07 (3.29 to 4.83)
    2.76 (2.60 to 2.89)
    Statistical analysis title
    		 Progression Free Survival (PFS)
    Comparison groups
    Ramucirumab + Docetaxel v Placebo + Docetaxel
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.696
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.573
         upper limit
    		 0.845
    Notes
    [1] - Stratified

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date. APD: All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67.
    End point type
    Secondary
    End point timeframe
    Randomization to Date of Death from Any Cause (Up to 31.1 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    263
    267
    Units: Months
        median (confidence interval 95%)
    9.40 (7.89 to 11.43)
    7.85 (7.00 to 9.30)
    Statistical analysis title
    		 Overall Survival (OS)
    Comparison groups
    Ramucirumab + Docetaxel v Placebo + Docetaxel
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2461 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.887
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.724
         upper limit
    		 1.086
    Notes
    [2] - Stratified

    Secondary: Percentage of Participants with an Objective Response Rate (ORR)

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    End point title
    		 Percentage of Participants with an Objective Response Rate (ORR)
    End point description
    ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 millimeter (mm). Tumor-marker results must have normalized. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Randomization to Disease Progression (Up to 29.7 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    263
    267
    Units: percentage of participants
        number (confidence interval 95%)
    25.9 (20.6 to 31.1)
    13.9 (9.7 to 18.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Disease Control Rate (DCR)

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    End point title
    		 Percentage of Participants with Disease Control Rate (DCR)
    End point description
    DCR is percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in sum of diameters of lesions vs baseline sum. Progressive Disease (PD): At least a 20% increase in sum of diameters of lesions vs smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Randomization to Disease Progression (Up to 29.7 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    263
    267
    Units: percentage of participants
        number (confidence interval 95%)
    65.4 (59.7 to 71.1)
    55.1 (49.1 to 61.0)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    Objective response was achieved if they had a best overall response of CR or PR. Target lesions- CR: Disappearance of all lesions;any pathological lymph nodes have reduction in short axis to <10 mm.PR: At least a 30% decrease in sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in sum of diameters of lesions vs smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or appearance of new lesion(s). If a participant was not known to have died or have radiographically documented PD as of data inclusion cutoff date, DOR was censored at the date of the last adequate tumor assessment. APD: All randomized participants
    End point type
    Secondary
    End point timeframe
    Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 28.4 Months) Participants censored in Ramucirumab + Docetaxel = 12 and in Placebo + Docetaxel = 5.
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    68
    37
    Units: Months
        median (confidence interval 95%)
    5.32 (3.94 to 6.87)
    4.17 (3.29 to 5.55)
    Statistical analysis title
    		 Duration of Response (DoR)
    Comparison groups
    Ramucirumab + Docetaxel v Placebo + Docetaxel
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.189
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.473
         upper limit
    		 1.158

    Secondary: Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale

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    End point title
    		 Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
    End point description
    Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL. APD: All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173.
    End point type
    Secondary
    End point timeframe
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    263
    267
    Units: Months
        median (confidence interval 95%)
    6.87 (4.24 to 8.90)
    4.60 (3.52 to 5.55)
    Statistical analysis title
    		 Global health status/QoL
    Comparison groups
    Ramucirumab + Docetaxel v Placebo + Docetaxel
    Number of subjects included in analysis
    530
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.357 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.879
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.663
         upper limit
    		 1.167
    Notes
    [3] - Global health status/QoL
    [4] - Stratified

    Secondary: Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

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    End point title
    		 Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
    End point description
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Scores range from 0 (death) to 1 (perfect health), but scores <0 are possible based on the algorithm. APD: All randomized participants with baseline and 30-day follow-up data.
    End point type
    Secondary
    End point timeframe
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    83
    102
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.10 ± 0.26
    -0.19 ± 0.26
    No statistical analyses for this end point

    Secondary: Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

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    End point title
    		 Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
    End point description
    The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a VAS ranging from 100 (best imaginable health state) to 0 (worst imaginable health state). APD: All randomized participants with baseline and 30-day follow-up data.
    End point type
    Secondary
    End point timeframe
    Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    86
    105
    Units: millimeter (mm)
        arithmetic mean (standard deviation)
    -7.87 ± 17.95
    -10.91 ± 16.77
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

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    End point title
    		 Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab [5]
    End point description
    Cmax of Ramucirumab at the end of ramucirumab infusion. APD: All randomized participants who had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and Cycle 9, Day 1: Predose, Postdose
    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: The endpoint is planned only for Ramucirumab arm in the baseline period per protocol.
    End point values
    		 Ramucirumab + Docetaxel
    Number of subjects analysed
    209 [6]
    Units: microgram/milliliter (μg/mL)
    geometric mean (geometric coefficient of variation)
        Cycle 1
    199 ± 28
        Cycle 9
    265 ± 29
    Notes
    [6] - Cycle 1: 209 Cycle 9: 22
    No statistical analyses for this end point

    Secondary: PK: Minimum Concentration (Cmin) of Ramucirumab

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    End point title
    		 PK: Minimum Concentration (Cmin) of Ramucirumab [7]
    End point description
    Cmin of Ramucirumab following administration every 3 weeks. APD: All randomized participants who had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint is planned only for Ramucirumab arm in the baseline period per protocol.
    End point values
    		 Ramucirumab + Docetaxel
    Number of subjects analysed
    188 [8]
    Units: μg/mL
    geometric mean (geometric coefficient of variation)
        Cycle 2
    14.9 ± 64
        Cycle 3
    23.5 ± 63
        Cycle 5
    32.5 ± 70
        Cycle 9
    48.9 ± 56
    Notes
    [8] - Cycle 2: 188; Cycle 3: 146; Cycle 5: 94; Cycle 9: 25
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Ramucirumab Antibodies

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    End point title
    		 Number of Participants with Anti-Ramucirumab Antibodies
    End point description
    Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. APD: All randomized participants who received at least one dose of study drug at baseline and post-baseline.
    End point type
    Secondary
    End point timeframe
    29.7 Months
    End point values
    		 Ramucirumab + Docetaxel Placebo + Docetaxel
    Number of subjects analysed
    199
    213
    Units: participants
    3
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 64.7 Months
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Placebo+Docetaxel
    Reporting group description
    		 Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Reporting group title
    Ramucirumab + Docetaxel
    Reporting group description
    		 Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Serious adverse events
    		 Placebo+Docetaxel Ramucirumab + Docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    107 / 265 (40.38%)
    111 / 258 (43.02%)
         number of deaths (all causes)
    209
    193
         number of deaths resulting from adverse events
    5
    8
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    tumour haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    arterial haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    aortic aneurysm
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    deep vein thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    embolism
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haematoma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypertension
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    venous occlusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    chest pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    1 / 2
    fatigue
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    5 / 258 (1.94%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    generalised oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    malaise
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mucosal inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    9 / 265 (3.40%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    2 / 10
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    female genital tract fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [1]
    0 / 265 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    epistaxis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hiccups
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    laryngeal inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    obstructive airways disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    7 / 265 (2.64%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    pneumothorax
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    pulmonary hypertension
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    delirium
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    device connection issue
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    blood creatinine increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutrophil count decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    platelet count decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infusion related reaction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lower limb fracture
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urostomy complication
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    arteriospasm coronary
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac arrest
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    cardiac failure
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    intracardiac thrombus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pericardial effusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    supraventricular tachycardia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    basilar artery thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    cerebrovascular accident
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral ischaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dizziness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subarachnoid haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    transient ischaemic attack
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    blood loss anaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    13 / 265 (4.91%)
    17 / 258 (6.59%)
         occurrences causally related to treatment / all
    11 / 14
    20 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    4 / 258 (1.55%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancytopenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    anal fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    constipation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastric haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    diarrhoea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    6 / 258 (2.33%)
         occurrences causally related to treatment / all
    3 / 5
    5 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fistula of small intestine
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    enterovesical fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    enterocolitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrointestinal ulcer
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    haemorrhoids
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ileal perforation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal ischaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    oesophagitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    tooth disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal perforation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stomatitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         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
    dermatitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rash
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    haematuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    4 / 258 (1.55%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hydronephrosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    ureteric stenosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (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
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    adrenal insufficiency
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bone pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    myalgia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    muscular weakness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    abdominal abscess
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bacteraemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cystitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    clostridium difficile colitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gingivitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    kidney infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (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
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neutropenic sepsis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    pneumonia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    5 / 258 (1.94%)
         occurrences causally related to treatment / all
    3 / 8
    3 / 5
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    pneumonia aspiration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    pyelonephritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    sepsis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    7 / 258 (2.71%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 4
    stoma site abscess
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    toxic shock syndrome
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    11 / 265 (4.15%)
    10 / 258 (3.88%)
         occurrences causally related to treatment / all
    2 / 15
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    decreased appetite
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    diabetic metabolic decompensation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperkalaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo+Docetaxel Ramucirumab + Docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    251 / 265 (94.72%)
    241 / 258 (93.41%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    neuroma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pyogenic granuloma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    tumour necrosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    tumour pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    9 / 265 (3.40%)
    1 / 258 (0.39%)
         occurrences all number
    13
    1
    Vascular disorders
    cyanosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    deep vein thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    2 / 258 (0.78%)
         occurrences all number
    4
    2
    embolism
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    flushing
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    4 / 258 (1.55%)
         occurrences all number
    2
    5
    haematoma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    hot flush
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    2
    hyperaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    hypotension
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    7 / 258 (2.71%)
         occurrences all number
    8
    10
    hypertension
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    15 / 265 (5.66%)
    34 / 258 (13.18%)
         occurrences all number
    22
    66
    lymphocele
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    lymphoedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    pallor
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pelvic venous thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    phlebitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    3
    thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    venous thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    varicose vein
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    vasculitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    6
    vena cava thrombosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    venous occlusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    catheter placement
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    central venous catheterisation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    endodontic procedure
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nail operation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    paracentesis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    skin lesion removal
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    tooth extraction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    administration site extravasation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    administration site rash
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    asthenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    24 / 265 (9.06%)
    29 / 258 (11.24%)
         occurrences all number
    38
    55
    catheter site erythema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    chest discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    chest pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    1 / 258 (0.39%)
         occurrences all number
    4
    1
    chills
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    9 / 265 (3.40%)
    6 / 258 (2.33%)
         occurrences all number
    12
    7
    face oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    3
    extravasation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    fatigue
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    106 / 265 (40.00%)
    98 / 258 (37.98%)
         occurrences all number
    188
    186
    gait disturbance
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    generalised oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    general physical health deterioration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    hypothermia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    injection site reaction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    5 / 258 (1.94%)
         occurrences all number
    1
    12
    injection site extravasation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    infusion site reaction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    infusion site extravasation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    4 / 258 (1.55%)
         occurrences all number
    0
    4
    influenza like illness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    7 / 265 (2.64%)
    14 / 258 (5.43%)
         occurrences all number
    7
    15
    localised oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    1 / 258 (0.39%)
         occurrences all number
    6
    2
    malaise
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    10 / 265 (3.77%)
    18 / 258 (6.98%)
         occurrences all number
    16
    31
    moaning
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    mucosal disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    mucosal inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    13 / 258 (5.04%)
         occurrences all number
    7
    26
    nodule
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    4 / 258 (1.55%)
         occurrences all number
    6
    4
    oedema peripheral
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    34 / 265 (12.83%)
    38 / 258 (14.73%)
         occurrences all number
    44
    52
    pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    10 / 258 (3.88%)
         occurrences all number
    8
    14
    oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    3
    peripheral swelling
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    3
    pyrexia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    42 / 265 (15.85%)
    44 / 258 (17.05%)
         occurrences all number
    63
    66
    swelling
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    swelling face
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    tenderness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    thirst decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    allergy to arthropod sting
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    drug hypersensitivity
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    2
    hypersensitivity
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    2 / 258 (0.78%)
         occurrences all number
    5
    2
    seasonal allergy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    breast pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    female genital tract fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [2]
    0 / 265 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    genital haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    3
    0
    genital ulceration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gynaecomastia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [3]
    1 / 214 (0.47%)
    1 / 209 (0.48%)
         occurrences all number
    1
    1
    intermenstrual bleeding
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [4]
    0 / 265 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    2
    oedema genital
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    pelvic discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    pelvic organ prolapse
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pelvic pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    5 / 258 (1.94%)
         occurrences all number
    4
    5
    penile pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [5]
    1 / 214 (0.47%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    perineal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    perineal ulceration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    scrotal oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [6]
    1 / 214 (0.47%)
    3 / 209 (1.44%)
         occurrences all number
    1
    3
    scrotal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [7]
    0 / 265 (0.00%)
    3 / 209 (1.44%)
         occurrences all number
    0
    3
    scrotal swelling
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [8]
    1 / 214 (0.47%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    testicular oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [9]
    1 / 214 (0.47%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    testicular pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [10]
    1 / 214 (0.47%)
    1 / 209 (0.48%)
         occurrences all number
    1
    1
    vaginal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [11]
    1 / 51 (1.96%)
    1 / 49 (2.04%)
         occurrences all number
    1
    1
    vulvovaginal pruritus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [12]
    0 / 265 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    vulval haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [13]
    0 / 265 (0.00%)
    1 / 49 (2.04%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    aphonia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    bronchospasm
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    chylothorax
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    cough
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    26 / 265 (9.81%)
    21 / 258 (8.14%)
         occurrences all number
    29
    30
    dyspnoea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    34 / 265 (12.83%)
    32 / 258 (12.40%)
         occurrences all number
    40
    50
    dysphonia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    8 / 258 (3.10%)
         occurrences all number
    3
    10
    dry throat
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    dyspnoea exertional
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    1 / 258 (0.39%)
         occurrences all number
    3
    1
    epistaxis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    14 / 265 (5.28%)
    39 / 258 (15.12%)
         occurrences all number
    16
    56
    haemoptysis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    hiccups
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    14 / 258 (5.43%)
         occurrences all number
    8
    21
    hypoxia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    laryngeal inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    laryngeal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    lung opacity
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nasal dryness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    oropharyngeal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    10 / 258 (3.88%)
         occurrences all number
    5
    11
    pleural effusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    4 / 258 (1.55%)
         occurrences all number
    2
    4
    pneumonitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    4 / 258 (1.55%)
         occurrences all number
    2
    4
    productive cough
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    4 / 258 (1.55%)
         occurrences all number
    2
    5
    pulmonary embolism
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    2
    pulmonary fibrosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pulmonary haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    rhinorrhoea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    7 / 258 (2.71%)
         occurrences all number
    6
    8
    respiratory tract congestion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    3 / 258 (1.16%)
         occurrences all number
    3
    3
    sinus congestion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    tracheal inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract congestion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    upper respiratory tract inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    upper-airway cough syndrome
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    3
    0
    wheezing
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    6 / 258 (2.33%)
         occurrences all number
    10
    6
    confusional state
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    1 / 258 (0.39%)
         occurrences all number
    4
    1
    depressive symptom
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    depression
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    3 / 258 (1.16%)
         occurrences all number
    4
    3
    delirium
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    disorientation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    emotional distress
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    euphoric mood
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    insomnia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    10 / 265 (3.77%)
    23 / 258 (8.91%)
         occurrences all number
    11
    25
    irritability
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    restlessness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    sleep disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    sleep talking
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    Product issues
    device occlusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    hepatic failure
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    hepatic function abnormal
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    hepatic pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    jaundice
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    Investigations
    activated partial thromboplastin time prolonged
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    9 / 258 (3.49%)
         occurrences all number
    8
    9
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    9 / 265 (3.40%)
    11 / 258 (4.26%)
         occurrences all number
    9
    12
    blood alkaline phosphatase
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    11 / 265 (4.15%)
    4 / 258 (1.55%)
         occurrences all number
    14
    4
    blood bilirubin increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    6
    blood calcium decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    blood creatine increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    21 / 265 (7.92%)
    8 / 258 (3.10%)
         occurrences all number
    31
    8
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    blood pressure decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    blood pressure increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    3 / 258 (1.16%)
         occurrences all number
    7
    9
    blood thyroid stimulating hormone increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    blood urea increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    blood uric acid increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    body temperature increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    carbon dioxide decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    3
    clostridium test positive
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    creatinine renal clearance decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    electrocardiogram st segment depression
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    10 / 265 (3.77%)
    1 / 258 (0.39%)
         occurrences all number
    13
    1
    heart rate increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    international normalised ratio increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    lymphocyte count decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    8 / 265 (3.02%)
    5 / 258 (1.94%)
         occurrences all number
    26
    15
    lymphocyte count increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    29 / 265 (10.94%)
    29 / 258 (11.24%)
         occurrences all number
    71
    93
    neutrophil count increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    platelet count decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    21 / 258 (8.14%)
         occurrences all number
    9
    56
    platelet count increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    protein total increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    protein urine
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    protein urine present
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    4
    prothrombin time prolonged
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    total lung capacity decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    troponin t increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    weight increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    1 / 258 (0.39%)
         occurrences all number
    3
    1
    weight decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    21 / 265 (7.92%)
    23 / 258 (8.91%)
         occurrences all number
    28
    26
    white blood cells urine positive
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    white blood cells urine
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    white blood cell count increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    white blood cell count decreased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    21 / 265 (7.92%)
    19 / 258 (7.36%)
         occurrences all number
    54
    77
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    eschar
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    fall
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    3
    fracture
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    head injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    infusion related reaction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    7 / 258 (2.71%)
         occurrences all number
    6
    9
    jaw fracture
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    joint injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    limb injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nail injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pelvic fracture
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    penis injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed [14]
    1 / 214 (0.47%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    periorbital haematoma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    post procedural haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences all number
    0
    3
    procedural pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    procedural nausea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    rib fracture
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    skin abrasion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    spinal fracture
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    thermal burn
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    stoma site pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    urinary tract stoma complication
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    vascular access complication
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    wound complication
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    wound
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    haemophilia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    atrial fibrillation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    atrioventricular block first degree
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    arrhythmia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    cardiac failure
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    cardiovascular disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    bradycardia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    left ventricular dysfunction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    palpitations
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    3
    pericardial effusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    sinus bradycardia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    sinus tachycardia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    0 / 258 (0.00%)
         occurrences all number
    4
    0
    right atrial enlargement
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    tachyarrhythmia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    tachycardia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    3 / 258 (1.16%)
         occurrences all number
    2
    3
    Nervous system disorders
    ageusia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    0 / 258 (0.00%)
         occurrences all number
    3
    0
    amnesia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    ataxia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    clonus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    depressed level of consciousness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    3
    0
    drooling
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    dizziness postural
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    dizziness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    9 / 265 (3.40%)
    7 / 258 (2.71%)
         occurrences all number
    9
    8
    disturbance in attention
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    dysgeusia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    18 / 265 (6.79%)
    28 / 258 (10.85%)
         occurrences all number
    19
    41
    dysarthria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    dysaesthesia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    head titubation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    headache
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    14 / 265 (5.28%)
    19 / 258 (7.36%)
         occurrences all number
    15
    27
    hypoaesthesia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    2 / 258 (0.78%)
         occurrences all number
    3
    2
    hypotonia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    lethargy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    3
    memory impairment
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    nervous system disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    neuralgia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    13 / 265 (4.91%)
    7 / 258 (2.71%)
         occurrences all number
    16
    9
    neurotoxicity
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    3 / 258 (1.16%)
         occurrences all number
    2
    3
    paraesthesia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    14 / 265 (5.28%)
    5 / 258 (1.94%)
         occurrences all number
    15
    7
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    22 / 265 (8.30%)
    18 / 258 (6.98%)
         occurrences all number
    31
    23
    peroneal nerve palsy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    polyneuropathy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    peripheral motor neuropathy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    presyncope
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    radiculopathy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    sciatica
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    syncope
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    taste disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    somnolence
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    tremor
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    2 / 258 (0.78%)
         occurrences all number
    4
    3
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    76 / 265 (28.68%)
    50 / 258 (19.38%)
         occurrences all number
    140
    87
    blood loss anaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    febrile neutropenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    9 / 258 (3.49%)
         occurrences all number
    5
    9
    leukocytosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    1 / 258 (0.39%)
         occurrences all number
    3
    1
    leukopenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    8 / 258 (3.10%)
         occurrences all number
    9
    25
    lymph node pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    lymphopenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    7
    neutropenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    14 / 265 (5.28%)
    18 / 258 (6.98%)
         occurrences all number
    14
    36
    thrombocytopenia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    6 / 258 (2.33%)
         occurrences all number
    3
    13
    thrombocytosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    ear discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    ear canal stenosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    hypoacusis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    middle ear inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    otorrhoea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    tinnitus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    vestibular disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    vertigo
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    0 / 258 (0.00%)
         occurrences all number
    4
    0
    Eye disorders
    dry eye
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    3 / 258 (1.16%)
         occurrences all number
    2
    3
    eczema eyelids
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    eye discharge
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    eye disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    eye pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    4
    eye pruritus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    eyelid function disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    eyelid oedema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    eyelid ptosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    glaucoma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    lacrimation increased
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    12 / 265 (4.53%)
    24 / 258 (9.30%)
         occurrences all number
    12
    28
    ocular discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    photopsia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    retinal vascular disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    vitreous haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    vitreous detachment
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    visual impairment
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    vision blurred
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    abdominal distension
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    7 / 258 (2.71%)
         occurrences all number
    5
    7
    abdominal wall disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    abdominal pain lower
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    10 / 265 (3.77%)
    12 / 258 (4.65%)
         occurrences all number
    10
    15
    abdominal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    17 / 265 (6.42%)
    20 / 258 (7.75%)
         occurrences all number
    22
    26
    anal fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    anal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    anal incontinence
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    anal inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    angular cheilitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    ascites
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    7 / 258 (2.71%)
         occurrences all number
    1
    8
    cheilitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    colitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    constipation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    45 / 265 (16.98%)
    35 / 258 (13.57%)
         occurrences all number
    58
    46
    diarrhoea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    56 / 265 (21.13%)
    81 / 258 (31.40%)
         occurrences all number
    81
    131
    dysphagia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    6 / 258 (2.33%)
         occurrences all number
    2
    6
    dyspepsia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    7 / 265 (2.64%)
    9 / 258 (3.49%)
         occurrences all number
    7
    10
    dyschezia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    dry mouth
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    11 / 258 (4.26%)
         occurrences all number
    5
    13
    ectopic gastric mucosa
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    eructation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    epigastric discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    enterocolitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    flatulence
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    faeces discoloured
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gastrointestinal obstruction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gastrointestinal motility disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gastritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gastric polyps
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    food poisoning
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    3 / 258 (1.16%)
         occurrences all number
    4
    8
    gingival atrophy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gingival bleeding
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences all number
    0
    3
    haematochezia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    3 / 258 (1.16%)
         occurrences all number
    2
    3
    glossitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gingival pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    hiatus hernia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    hyperchlorhydria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    haemorrhoids
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    8 / 258 (3.10%)
         occurrences all number
    2
    9
    ileus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    intestinal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    intra-abdominal haematoma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    large intestinal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    lip blister
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    mouth ulceration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    melaena
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    lip dry
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    mucous stools
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    odynophagia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    nausea
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    55 / 265 (20.75%)
    71 / 258 (27.52%)
         occurrences all number
    82
    102
    obstruction gastric
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    5
    oral disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    oral hyperaesthesia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    oral pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    periodontal disease
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    2
    proctalgia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    proctitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    rectal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    1 / 258 (0.39%)
         occurrences all number
    3
    1
    rectal prolapse
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    rectal tenesmus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    stomatitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    30 / 265 (11.32%)
    66 / 258 (25.58%)
         occurrences all number
    36
    117
    toothache
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    1 / 258 (0.39%)
         occurrences all number
    4
    1
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    vomiting
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    40 / 265 (15.09%)
    41 / 258 (15.89%)
         occurrences all number
    56
    62
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    alopecia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    94 / 265 (35.47%)
    66 / 258 (25.58%)
         occurrences all number
    115
    79
    dermatitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    decubitus ulcer
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    dermatitis acneiform
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    dry skin
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    11 / 258 (4.26%)
         occurrences all number
    6
    12
    drug eruption
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    eczema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    4
    epidermolysis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    erythema
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    6 / 258 (2.33%)
         occurrences all number
    3
    7
    erythema multiforme
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    0 / 258 (0.00%)
         occurrences all number
    3
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    2
    nail bed disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nail bed inflammation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nail discolouration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    15 / 265 (5.66%)
    7 / 258 (2.71%)
         occurrences all number
    15
    7
    nail disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    3 / 258 (1.16%)
         occurrences all number
    3
    3
    nail dystrophy
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nail toxicity
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    4
    night sweats
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    2
    nail ridging
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    6 / 258 (2.33%)
         occurrences all number
    3
    7
    onychalgia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    5
    onycholysis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    5 / 258 (1.94%)
         occurrences all number
    3
    7
    onychomadesis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    8 / 258 (3.10%)
         occurrences all number
    5
    10
    onychoclasis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pain of skin
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences all number
    0
    3
    palmar-plantar erythrodysaesthesia syndrome
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    19 / 258 (7.36%)
         occurrences all number
    15
    28
    photosensitivity reaction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    pruritus
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    12 / 265 (4.53%)
    10 / 258 (3.88%)
         occurrences all number
    17
    11
    rash
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    15 / 265 (5.66%)
    11 / 258 (4.26%)
         occurrences all number
    18
    14
    rash erythematous
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    rash maculo-papular
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    0 / 258 (0.00%)
         occurrences all number
    5
    0
    skin burning sensation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    skin discolouration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    skin disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    skin exfoliation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    skin fissures
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    skin hyperpigmentation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    2
    skin lesion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    skin ulcer
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    3
    urticaria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    5 / 258 (1.94%)
         occurrences all number
    4
    5
    xeroderma
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    5 / 258 (1.94%)
         occurrences all number
    0
    5
    anuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    bladder pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    chromaturia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    chronic kidney disease
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    cystitis noninfective
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    cystitis interstitial
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    dysuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    3 / 258 (1.16%)
         occurrences all number
    4
    3
    haematuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    19 / 265 (7.17%)
    30 / 258 (11.63%)
         occurrences all number
    20
    48
    hydronephrosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    hydroureter
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    micturition urgency
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    nocturia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pollakiuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    3 / 258 (1.16%)
         occurrences all number
    4
    3
    polyuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    proteinuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    16 / 265 (6.04%)
    33 / 258 (12.79%)
         occurrences all number
    28
    60
    renal failure
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    renal impairment
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    renal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    urinary hesitation
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    urethral haemorrhage
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    urinary fistula
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    urinary tract pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    urinary tract obstruction
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    urinary retention
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    1 / 258 (0.39%)
         occurrences all number
    6
    1
    urinary incontinence
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    1 / 258 (0.39%)
         occurrences all number
    6
    1
    urine odour abnormal
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    Endocrine disorders
    adrenal insufficiency
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    hypothyroidism
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    26 / 265 (9.81%)
    30 / 258 (11.63%)
         occurrences all number
    34
    39
    arthritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    back pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    21 / 265 (7.92%)
    29 / 258 (11.24%)
         occurrences all number
    26
    36
    bone pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    17 / 265 (6.42%)
    15 / 258 (5.81%)
         occurrences all number
    19
    15
    flank pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    3 / 258 (1.16%)
         occurrences all number
    6
    3
    groin pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    7 / 265 (2.64%)
    4 / 258 (1.55%)
         occurrences all number
    7
    6
    intervertebral disc disorder
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    inguinal mass
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    joint effusion
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    joint swelling
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    limb discomfort
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    muscle fatigue
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    muscle spasms
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    2 / 258 (0.78%)
         occurrences all number
    4
    4
    muscle twitching
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    muscular weakness
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    6 / 265 (2.26%)
    5 / 258 (1.94%)
         occurrences all number
    7
    6
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    4 / 258 (1.55%)
         occurrences all number
    3
    4
    musculoskeletal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    1 / 258 (0.39%)
         occurrences all number
    4
    1
    myalgia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    23 / 265 (8.68%)
    24 / 258 (9.30%)
         occurrences all number
    30
    39
    myofascitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    neck mass
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    neck pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    3 / 258 (1.16%)
         occurrences all number
    7
    3
    osteoarthritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    osteonecrosis of jaw
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pain in extremity
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    16 / 265 (6.04%)
    12 / 258 (4.65%)
         occurrences all number
    22
    15
    pain in jaw
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    polymyalgia rheumatica
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pubic pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    sacral pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    spinal pain
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    abscess intestinal
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    anal abscess
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    bacteraemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    bacteriuria
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    covid-19
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    cellulitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    2 / 258 (0.78%)
         occurrences all number
    2
    3
    breast cellulitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    bronchitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    4 / 258 (1.55%)
         occurrences all number
    3
    4
    conjunctivitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    5 / 258 (1.94%)
         occurrences all number
    1
    6
    cystitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    device related infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    dacryocystitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    enterovirus infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    eye infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    gastroenteritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    furuncle
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    fungal infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    gingivitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    4 / 258 (1.55%)
         occurrences all number
    2
    4
    helicobacter infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    herpes dermatitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    herpes virus infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    herpes zoster
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    2 / 258 (0.78%)
         occurrences all number
    1
    2
    influenza
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    3
    infective glossitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    kidney infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    nail bed infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    3
    nail infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    5 / 258 (1.94%)
         occurrences all number
    1
    7
    mucosal infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    5 / 258 (1.94%)
         occurrences all number
    3
    5
    onychomycosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    oral candidiasis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    5 / 258 (1.94%)
         occurrences all number
    3
    5
    oral fungal infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    oral herpes
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    paronychia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    3
    parotitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    perineal abscess
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    2
    0
    perineal infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    postoperative wound infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    peritonitis bacterial
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pharyngitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    2
    pneumonia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    3 / 265 (1.13%)
    1 / 258 (0.39%)
         occurrences all number
    5
    1
    post procedural infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    pyelonephritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    2
    pyelonephritis acute
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    respiratory tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    respiratory tract infection viral
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    rhinitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    3 / 258 (1.16%)
         occurrences all number
    1
    5
    sepsis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    sinusitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    2 / 265 (0.75%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    skin infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    spinal cord infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    tooth infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    3 / 258 (1.16%)
         occurrences all number
    0
    3
    tooth abscess
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    2 / 258 (0.78%)
         occurrences all number
    0
    2
    tonsillitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    tinea pedis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    tracheitis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    9 / 265 (3.40%)
    5 / 258 (1.94%)
         occurrences all number
    9
    5
    urethritis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    urinary tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    34 / 265 (12.83%)
    31 / 258 (12.02%)
         occurrences all number
    39
    38
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    viral infection
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    acidosis
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    cachexia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    dehydration
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    8 / 258 (3.10%)
         occurrences all number
    5
    8
    decreased appetite
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    64 / 265 (24.15%)
    82 / 258 (31.78%)
         occurrences all number
    82
    128
    fluid retention
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    0 / 265 (0.00%)
    1 / 258 (0.39%)
         occurrences all number
    0
    1
    gout
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    hypercalcaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    12 / 265 (4.53%)
    6 / 258 (2.33%)
         occurrences all number
    15
    11
    hyperglycaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    13 / 265 (4.91%)
    8 / 258 (3.10%)
         occurrences all number
    15
    12
    hyperkalaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    7 / 265 (2.64%)
    12 / 258 (4.65%)
         occurrences all number
    12
    26
    hypophosphataemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    7 / 265 (2.64%)
    6 / 258 (2.33%)
         occurrences all number
    8
    10
    hypophagia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    hyponatraemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    10 / 265 (3.77%)
    7 / 258 (2.71%)
         occurrences all number
    11
    10
    hypomagnesaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    4 / 258 (1.55%)
         occurrences all number
    7
    4
    hypokalaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    5 / 265 (1.89%)
    3 / 258 (1.16%)
         occurrences all number
    7
    3
    hypocalcaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    4 / 265 (1.51%)
    2 / 258 (0.78%)
         occurrences all number
    6
    2
    hypoalbuminaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    26 / 265 (9.81%)
    17 / 258 (6.59%)
         occurrences all number
    32
    25
    hyperuricaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    15 / 265 (5.66%)
    10 / 258 (3.88%)
         occurrences all number
    17
    11
    hypernatraemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    0 / 258 (0.00%)
         occurrences all number
    1
    0
    hypermagnesaemia
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    2
    1
    vitamin d deficiency
    alternative dictionary used: MedDRA 26.0
         subjects affected / exposed
    1 / 265 (0.38%)
    1 / 258 (0.39%)
         occurrences all number
    1
    1
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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