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    Clinical Trial Results:
    An Open-Label, Multicentre, Single-Arm Study to Characterise the Efficacy, Safety, and Tolerability of Gefitinib 250 mg (IRESSA™1) as First-Line Treatment in Caucasian Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2005-004548-30
    Trial protocol
    		 DK  
    Global end of trial date
    26 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2016
    First version publication date
    25 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1839IL/0225
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00229697
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astra Zeneca
    Sponsor organisation address
    Mereside Block 11S, Alderley Park, United Kingdom, SK10 4TG
    Public contact
    Yuri Rukazenkov, Astra Zeneca, +44 1625 231825, yuri.rukazenkov@astrazeneca.com
    Scientific contact
    Yuri Rukazenkov, Astra Zeneca, + 44 1625 231825, yuri.rukazenkov@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Patients were stratified into 2 categories based on their prior hormonal therapy. The 2 strata were as follows: 1) Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study and 2) Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease. The primary objectives of the study were: Stratum 1: To compare the time to progression (TTP) between 2 treatment arms (tamoxifen + gefitinib [IRESSA™ ] versus tamoxifen + placebo). Stratum 2: To compare the clinical benefit rate (CBR) between 2 treatment arms (tamoxifen + gefitinib versus tamoxifen + placebo).
    Protection of trial subjects
    All patients entered into the study adhered to the inclusion and exclusion criteria and were free to withdraw at any time. Patients were monitored for safety and efficacy throughout the study which was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable regulatory requirements and the AstraZeneca policy on Bioethics.
    Background therapy
    		 Nolvadex one 20 mg tablet daily
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2003
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 23
    Country: Number of subjects enrolled
    Australia: 25
    Country: Number of subjects enrolled
    Belgium: 43
    Country: Number of subjects enrolled
    Brazil: 28
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 27
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    South Africa: 12
    Country: Number of subjects enrolled
    Spain: 22
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    United States: 22
    Worldwide total number of subjects
    289
    EEA total number of subjects
    143
    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)
    166
    From 65 to 84 years
    120
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 First subject was enrolled on 14 October 2003, last subject was enrolled on 30 June 2006

    Pre-assignment
    Screening details
    		 All patients must be female; >18 yrs; have WHO PS of 0, 1 or 2; fulfil the inclusion and exclusion criteria, and have histologically confirmed metastatic adenocarcinoma of the breast that is ER and/or PR positive

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Data analyst, Assessor, Subject
    Blinding implementation details
    Tablets and packaging of ZD1839 250 mg and placebo to ZD1839 will be visually identical. Participating patients, medical staff and ancillary medical staff remained blinded as to the assignment of ZD1839 or placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Strata 1, Nolvadex + Gefitinib
    Arm description
    		 Nolvadex 20mg + Gefitinib 250mg once daily. Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250mg once daily

    Arm title
    		 Strata 1, Nolvadex + placebo
    Arm description
    		 Nolvadex 20mg + placebo once daily. Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    matched placebo

    Arm title
    		 Strata 2, Nolvadex + Gefitinib
    Arm description
    		 Nolvadex 20mg + Gefitinib 250mg once daily. Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gefitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250mg once daily

    Arm title
    		 Strata 2, Nolvadex + Placebo
    Arm description
    		 Nolvadex 20mg + placebo once daily. Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    matched placebo

    Number of subjects in period 1
    		Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo
    Started
    105
    101
    48
    35
    Completed
    98
    94
    41
    30
    Not completed
    7
    7
    7
    5
         not recorded
    1
    2
    3
    3
         Consent withdrawn by subject
    1
    1
    2
    -
         Eligibility criteria not fulfilled
    -
    1
    1
    1
         Adverse Event
    5
    1
    -
    -
         Lost to follow-up
    -
    2
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Strata 1, Nolvadex + Gefitinib
    Reporting group description
    		 Nolvadex 20mg + Gefitinib 250mg once daily. Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study

    Reporting group title
    Strata 1, Nolvadex + placebo
    Reporting group description
    		 Nolvadex 20mg + placebo once daily. Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study

    Reporting group title
    Strata 2, Nolvadex + Gefitinib
    Reporting group description
    		 Nolvadex 20mg + Gefitinib 250mg once daily. Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease.

    Reporting group title
    Strata 2, Nolvadex + Placebo
    Reporting group description
    		 Nolvadex 20mg + placebo once daily. Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease.

    Reporting group values
    		 Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo Total
    Number of subjects
    		 105 101 48 35 289
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-65 years)
    		 64 58 30 14 166
        From 66-84 years
    		 39 42 18 21 120
        85 years and over
    		 2 1 0 0 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61 ( 11.93 ) 62 ( 11.68 ) 62.9 ( 8.36 ) 66.3 ( 8.57 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 105 101 48 35 289
        Male
    		 0 0 0 0 0
    Human Epidermal Growth Factor Receptor 2 (HER2) status
    Units: Subjects
        HER2 Positive
    		 22 15 4 2 43
        HER2 Negative
    		 83 86 44 33 246
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients that are enrolled and receive study treatment are included in the intention-to-treat (ITT) population. The analysis population for all efficacy outcome variables will be the ITT population.

    Subject analysis sets values
    		 Intention-to-treat (ITT)
    Number of subjects
    289
    Age Categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-65 years)
    166
        From 66-84 years
    120
        85 years and over
    3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    62.3 ( 11.02 )
    Gender Categorical
    Units: Subjects
        Female
    289
        Male
    0
    Human Epidermal Growth Factor Receptor 2 (HER2) status
    Units: Subjects
        HER2 Positive
        HER2 Negative

    End points

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    End points reporting groups
    Reporting group title
    Strata 1, Nolvadex + Gefitinib
    Reporting group description
    		 Nolvadex 20mg + Gefitinib 250mg once daily. Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study

    Reporting group title
    Strata 1, Nolvadex + placebo
    Reporting group description
    		 Nolvadex 20mg + placebo once daily. Stratum 1- patients with newly diagnosed disease or patients who had completed adjuvant therapy with tamoxifen (Nolvadex) at least 1 year prior to starting this study

    Reporting group title
    Strata 2, Nolvadex + Gefitinib
    Reporting group description
    		 Nolvadex 20mg + Gefitinib 250mg once daily. Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease.

    Reporting group title
    Strata 2, Nolvadex + Placebo
    Reporting group description
    		 Nolvadex 20mg + placebo once daily. Stratum 2 - patients with recurrent disease during, or after adjuvant aromatase inhibitor (AI), or failing first line treatment with an AI for metastatic disease.

    Subject analysis set title
    Intention-to-treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients that are enrolled and receive study treatment are included in the intention-to-treat (ITT) population. The analysis population for all efficacy outcome variables will be the ITT population.

    Primary: Stratum 1: Time to Progression (progressive disease or death) (TTP)

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    End point title
    		 Stratum 1: Time to Progression (progressive disease or death) (TTP) [1]
    End point description
    Stratum 1: To compare the Time to Progression (time from randomisation to progressive disease or death) between 2 treatment arms
    End point type
    Primary
    End point timeframe
    Tumour assessments to be performed at baseline and then every three months until discontinuation
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: 2.Time to Progression (TTP) for Stratum 1 is a secondary endpoint. According to Protocol there is no analysis for secondary endpoints
    End point values
    		 Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo
    Number of subjects analysed
    105
    101
    Units: Days
        median (inter-quartile range (Q1-Q3))
    331 (92 to 722)
    267 (99 to 549)
    Statistical analysis title
    		 Stratum 1: Time to Progression
    Statistical analysis description
    The Cox proportional hazards model was used to estimate the TTP hazard ratio for placebo relative to gefitinib, adjusted for the following baseline factors:• Her2neu expression (positive versus negative)• PgR status (positive versus negative)• WHO performance status (0-1 versus 2)• Visceral metastases (yes versus no)
    Comparison groups
    Strata 1, Nolvadex + Gefitinib v Strata 1, Nolvadex + placebo
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.3141 [3]
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.69
    Notes
    [2] - Stratum 1: Time to Progression (progressive disease or death)
    [3] - P-values were presented for illustrative purposes only

    Primary: Stratum 2: Clinical Benefit Rate (CBR)

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    End point title
    		 Stratum 2: Clinical Benefit Rate (CBR) [4]
    End point description
    Stratum 2: Clinical Benefit Rate (CBR) is the proportion of patients with either complete response (CR), Partial response (PR) or Stable disease (SD) for more than 24 weeks. Response is measured by RECIST (The Response Evaluation Criteria in Solid Tumours).
    End point type
    Primary
    End point timeframe
    Tumour assessment carried out at baseline and then every 3 months until discontinuation.
    Notes
    [4] - 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: 1.Clinical Benefit Rate (CBR) for Stratum 2 is a secondary endpoint. According to Protocol there is no analysis for secondary endpoints.
    End point values
    		 Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo
    Number of subjects analysed
    48
    35
    Units: percentage
        number (not applicable)
    29.2
    31.4
    Statistical analysis title
    		 Stratum 2: Clinical benefit Rate
    Statistical analysis description
    The proportions of patients who experienced clinical benefit was compared between the tamoxifen + gefitinib and tamoxifen + placebo arms using logistic regression. The model included the following baseline factors:• Her2neu expression (0/1+ versus 2+ versus 3+)• PgR status (positive versus negative)• WHO performance status (0-1 versus 2)• Visceral metastases (yes versus no)
    Comparison groups
    Strata 2, Nolvadex + Gefitinib v Strata 2, Nolvadex + Placebo
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5167 [5]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 1.95
    Notes
    [5] - P-values were presented for illustrative purposes only

    Secondary: Stratum 1: Clinical Benefit Rate (CBR)

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    End point title
    		 Stratum 1: Clinical Benefit Rate (CBR) [6]
    End point description
    Stratum 1: Clinical Benefit Rate (CBR) is the proportion of patients with either complete response (CR), Partial response (PR) or Stable disease (SD) for more than 24 weeks. Response is measured by RECIST (The Response Evaluation Criteria in Solid Tumours).
    End point type
    Secondary
    End point timeframe
    Tumour assessment carried out at baseline and then every 3 months until discontinuation.
    Notes
    [6] - 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: 1.Clinical Benefit Rate (CBR) for Stratum 1 is a secondary endpoint. According to Protocol there is no analysis for secondary endpoints.
    End point values
    		 Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo
    Number of subjects analysed
    105
    101
    Units: percentage
        number (not applicable)
    50.5
    45.5
    No statistical analyses for this end point

    Secondary: Stratum 2: Time to progression (TTP)

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    End point title
    		 Stratum 2: Time to progression (TTP) [7]
    End point description
    Stratum 1: To compare the Time to Progression (TTP) (time from randomisation to progressive disease or death) between 2 treatment arms
    End point type
    Secondary
    End point timeframe
    Tumour assessments to be performed at baseline and then every three months until discontinuation
    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: 2.Time to Progression (TTP) for Stratum 2 is a secondary endpoint. According to Protocol there is no analysis for secondary endpoints.
    End point values
    		 Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo
    Number of subjects analysed
    48
    35
    Units: days
        median (inter-quartile range (Q1-Q3))
    174 (88 to 338)
    214 (90 to 372)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    Objective Response Rate (ORR) is the proportion of patients with either complete response (CR) or Partial response (PR). Response is measured by RECIST (The Response Evaluation Criteria in Solid Tumours).
    End point type
    Secondary
    End point timeframe
    Tumour assessments to be performed at baseline and then every three months until discontinuation
    End point values
    		 Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo
    Number of subjects analysed
    105
    101
    48
    35
    Units: percentage
        number (not applicable)
    12.4
    14.9
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of Response is the time from first response to progression, for patients who have either a Complete Response (CR) or Partial Response (PR). Response is measured by RECIST (The Response Evaluation Criteria in Solid Tumours).
    End point type
    Secondary
    End point timeframe
    Tumour assessments to be performed at baseline and then every three months until discontinuation
    End point values
    		 Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo
    Number of subjects analysed
    13 [8]
    15 [9]
    0 [10]
    0 [11]
    Units: days
        median (inter-quartile range (Q1-Q3))
    502 (367 to 999999999999)
    380 (271 to 999999999999)
    ( to )
    ( to )
    Notes
    [8] - Only patients with a response of CR or PR are included in this analysis.
    [9] - Only patients with a response of CR or PR are included in this analysis.
    [10] - No patients in this group had a response of CR or PR so no patients are included in this analysis.
    [11] - No patients in this group had a response of CR or PR so no patients are included in this analysis.
    No statistical analyses for this end point

    Secondary: Objective Response Rate within HER2 positive subgroup.

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    End point title
    		 Objective Response Rate within HER2 positive subgroup.
    End point description
    Objective Response Rate (ORR) is the proportion of patients with either complete response (CR) or Partial response (PR). Response is measured by RECIST (The Response Evaluation Criteria in Solid Tumours).
    End point type
    Secondary
    End point timeframe
    Tumour assessments to be performed at baseline and then every three months until discontinuation
    End point values
    		 Strata 1, Nolvadex + Gefitinib Strata 1, Nolvadex + placebo Strata 2, Nolvadex + Gefitinib Strata 2, Nolvadex + Placebo
    Number of subjects analysed
    22 [12]
    15 [13]
    4 [14]
    2 [15]
    Units: percentage
        number (not applicable)
    13.6
    6.7
    0
    0
    Notes
    [12] - Number of patients analysed is the number of patients within group who are HER2 positve
    [13] - Number of patients analysed is the number of patients within group who are HER2 positve
    [14] - Number of patients analysed is the number of patients within group who are HER2 positve
    [15] - Number of patients analysed is the number of patients within group who are HER2 positve
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Event data were collected at each visit (ie days 1, 30, 90, 180 and every 3 months; also at discontinuation and 30 days post discontinuation).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Stratum 1: Tamoxifen + Gefitinib
    Reporting group description
    		 Tamoxifen 20 mg od + Gefitinib 250 mg od

    Reporting group title
    Stratum 1: Tamoxifen + Placebo
    Reporting group description
    		 Tamoxifen 20 mg od + Placebo gefitinib od

    Reporting group title
    Stratum 2: Tamoxifen + Gefitinib
    Reporting group description
    		 Tamoxifen 20 mg od + Gefitinib 250 mg od

    Reporting group title
    Stratum 2: Tamoxifen + Placebo
    Reporting group description
    		 Tamoxifen 20 mg od + Placebo gefitinib od

    Serious adverse events
    		 Stratum 1: Tamoxifen + Gefitinib Stratum 1: Tamoxifen + Placebo Stratum 2: Tamoxifen + Gefitinib Stratum 2: Tamoxifen + Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 105 (27.62%)
    16 / 101 (15.84%)
    11 / 48 (22.92%)
    5 / 35 (14.29%)
         number of deaths (all causes)
    25
    24
    11
    9
         number of deaths resulting from adverse events
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant Neoplasm Progression
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep Vein Thrombosis
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Lymphadenectomy
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastectomy
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General Physical Health Deteriotation
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial Hyperplasia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal Haemorrhage
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dispnoea
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Traumatic Brain Injury
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troatic Vertebral Fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Miocardial Infarction
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Coordination Abnormal
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurological Symptom
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Ischaemia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 105 (3.81%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone Pain
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea Infectious
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection Bacterial
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Stratum 1: Tamoxifen + Gefitinib Stratum 1: Tamoxifen + Placebo Stratum 2: Tamoxifen + Gefitinib Stratum 2: Tamoxifen + Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    105 / 105 (100.00%)
    87 / 101 (86.14%)
    44 / 48 (91.67%)
    28 / 35 (80.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumor Pain
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Uterine Leiomyoma
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Haematoma
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hot Flush
         subjects affected / exposed
    12 / 105 (11.43%)
    21 / 101 (20.79%)
    3 / 48 (6.25%)
    4 / 35 (11.43%)
         occurrences all number
    12
    24
    3
    6
    Hypertension
         subjects affected / exposed
    3 / 105 (2.86%)
    2 / 101 (1.98%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    3
    2
    1
    1
    Lymphoedema
         subjects affected / exposed
    1 / 105 (0.95%)
    4 / 101 (3.96%)
    3 / 48 (6.25%)
    0 / 35 (0.00%)
         occurrences all number
    1
    4
    3
    0
    Orthostatic Hypotension
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pallor
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Phlebitis
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    2
    0
    0
    2
    Phlebitis Superficial
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Varicose Vein
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Venous Insufficiency
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    Preventive Surgery
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 105 (3.81%)
    3 / 101 (2.97%)
    6 / 48 (12.50%)
    5 / 35 (14.29%)
         occurrences all number
    4
    3
    7
    6
    Chest Discomfort
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Chills
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    1
    Fatigue
         subjects affected / exposed
    17 / 105 (16.19%)
    18 / 101 (17.82%)
    6 / 48 (12.50%)
    6 / 35 (17.14%)
         occurrences all number
    19
    23
    7
    9
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    1
    Influenza Like Illness
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mucosal Dryness
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    2
    1
    Mucosal Imflammation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oedema
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Oedema Peripheral
         subjects affected / exposed
    4 / 105 (3.81%)
    5 / 101 (4.95%)
    3 / 48 (6.25%)
    2 / 35 (5.71%)
         occurrences all number
    5
    5
    4
    3
    Pain
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Pirexia
         subjects affected / exposed
    4 / 105 (3.81%)
    2 / 101 (1.98%)
    3 / 48 (6.25%)
    1 / 35 (2.86%)
         occurrences all number
    4
    2
    4
    1
    Adverse Drug Reaction
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Chest Pain
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Face Oedema
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Local Swelling
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Mucosal Haemorrhage
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seasonal Allergy
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Allergy To Plants
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Breast Inflammation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Breast Pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Cystocele
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspareunia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Genital Rash
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pelvic Pain
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Vaginal Discharge
         subjects affected / exposed
    4 / 105 (3.81%)
    4 / 101 (3.96%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    4
    4
    0
    1
    Vulval Erythema
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vulvovaginal Pruritus
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    1
    1
    Genital Discharge
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    1
    Vaginal Haemorrhage
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    0
    1
    Uterine Polyp
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metrorrhagia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Vulvovaginal Dryness
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus Genital
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cough
         subjects affected / exposed
    8 / 105 (7.62%)
    5 / 101 (4.95%)
    2 / 48 (4.17%)
    3 / 35 (8.57%)
         occurrences all number
    9
    5
    2
    3
    Dispnoea
         subjects affected / exposed
    11 / 105 (10.48%)
    10 / 101 (9.90%)
    4 / 48 (8.33%)
    6 / 35 (17.14%)
         occurrences all number
    16
    11
    5
    6
    Dispnoea Exertional
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    5 / 105 (4.76%)
    0 / 101 (0.00%)
    4 / 48 (8.33%)
    0 / 35 (0.00%)
         occurrences all number
    6
    0
    5
    0
    Lung Infiltration
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal Congestion
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasal Dryness
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Nasal Imflammation
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nasal Mucosal Disorder
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Pharyngolaryngeal Pain
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Pleural Effusion
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    1 / 35 (2.86%)
         occurrences all number
    4
    0
    2
    1
    Productive Couth
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pulmonary Congestion
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinitis Allergic
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    7 / 105 (6.67%)
    5 / 101 (4.95%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    7
    5
    1
    0
    Confusional State
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    1
    Depression
         subjects affected / exposed
    7 / 105 (6.67%)
    2 / 101 (1.98%)
    4 / 48 (8.33%)
    0 / 35 (0.00%)
         occurrences all number
    7
    2
    4
    0
    Insomnia
         subjects affected / exposed
    9 / 105 (8.57%)
    6 / 101 (5.94%)
    2 / 48 (4.17%)
    2 / 35 (5.71%)
         occurrences all number
    9
    6
    2
    2
    Sleep Desorder
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Depressed Mood
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Restlessness
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    International Normalised Ratio Abnormal
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Weight Increased
         subjects affected / exposed
    2 / 105 (1.90%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Weight Decreased
         subjects affected / exposed
    6 / 105 (5.71%)
    1 / 101 (0.99%)
    2 / 48 (4.17%)
    1 / 35 (2.86%)
         occurrences all number
    12
    1
    2
    1
    Blood Cholesterol Increased
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haemoglobin Decreased
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    1
    Blood Creatinin Increased
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    C-Reactive Protein Increased
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Transaminases Increased
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Anal Injury
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Arthropod Bite
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Contusion
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Drug Toxicity
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Procedural Pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seroma
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Traumatic Haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wrist Fracture
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ankle Fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Thermal Burn
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper Lumb Fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hand Fracture
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Excoration
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Radiation Skin Injury
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wound Complication
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fall
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palpitations
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    11 / 105 (10.48%)
    7 / 101 (6.93%)
    3 / 48 (6.25%)
    1 / 35 (2.86%)
         occurrences all number
    11
    7
    3
    2
    Dysgeusia
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    4
    1
    1
    0
    Facial Paresis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    13 / 105 (12.38%)
    11 / 101 (10.89%)
    6 / 48 (12.50%)
    1 / 35 (2.86%)
         occurrences all number
    19
    14
    6
    3
    Hyperaesthesia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hypogeusia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
         subjects affected / exposed
    3 / 105 (2.86%)
    2 / 101 (1.98%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    2
    4
    0
    Paraesthesia
         subjects affected / exposed
    2 / 105 (1.90%)
    3 / 101 (2.97%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    4
    1
    0
    Parkinsonism
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Syncope
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Amnesia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neuralgia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Migraine
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Memory Impairment
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Paresis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Speech Disorder
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 105 (5.71%)
    7 / 101 (6.93%)
    1 / 48 (2.08%)
    3 / 35 (8.57%)
         occurrences all number
    7
    8
    4
    3
    Neutropenia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Leukopenia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cataract
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    6 / 105 (5.71%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    7
    0
    1
    0
    Dry Eye
         subjects affected / exposed
    5 / 105 (4.76%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    6
    2
    1
    1
    Erythema of Eyelid
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Eye Inflammation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye Irritation
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eye Pain
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Eye Pruritus
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    3
    0
    1
    1
    Eyelid Pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Eyelids Pruritus
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foreign Body Sensation In Eyes
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lacrimation Increased
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Madarosis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    3
    0
    Ocular Hyperaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Panophthalmitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blepharospasm
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Diplopia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Ectropion
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid Irritation
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Eyelid Oedema
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Glaucoma
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Photophobia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vision Blurred
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal Pain
         subjects affected / exposed
    6 / 105 (5.71%)
    6 / 101 (5.94%)
    3 / 48 (6.25%)
    1 / 35 (2.86%)
         occurrences all number
    9
    7
    3
    1
    Abdominal Pain Upper
         subjects affected / exposed
    3 / 105 (2.86%)
    3 / 101 (2.97%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    3
    2
    0
    Abdominal Pain Lower
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anal Fissure
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Anal Haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Aphthous Stomatitis
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    0
    1
    Cheilitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    11 / 105 (10.48%)
    8 / 101 (7.92%)
    3 / 48 (6.25%)
    5 / 35 (14.29%)
         occurrences all number
    12
    10
    3
    5
    Diarrhoea
         subjects affected / exposed
    62 / 105 (59.05%)
    24 / 101 (23.76%)
    28 / 48 (58.33%)
    7 / 35 (20.00%)
         occurrences all number
    97
    28
    42
    10
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dry Mouth
         subjects affected / exposed
    8 / 105 (7.62%)
    5 / 101 (4.95%)
    4 / 48 (8.33%)
    1 / 35 (2.86%)
         occurrences all number
    9
    5
    6
    1
    Duodenal Ulcer
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Duodenitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    10 / 105 (9.52%)
    6 / 101 (5.94%)
    5 / 48 (10.42%)
    1 / 35 (2.86%)
         occurrences all number
    10
    7
    5
    1
    Dysphagia
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Enteritis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    1
    0
    1
    Gastric Ulcer
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastritis
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 105 (0.95%)
    2 / 101 (1.98%)
    5 / 48 (10.42%)
    0 / 35 (0.00%)
         occurrences all number
    1
    2
    5
    0
    Gingival Bleeding
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Glossodynia
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Haemorroids
         subjects affected / exposed
    4 / 105 (3.81%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    6
    0
    1
    0
    Mouth Haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mouth Ulceration
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nausea
         subjects affected / exposed
    36 / 105 (34.29%)
    29 / 101 (28.71%)
    12 / 48 (25.00%)
    6 / 35 (17.14%)
         occurrences all number
    42
    34
    15
    7
    Proctalgia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus Ani
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    5 / 105 (4.76%)
    1 / 101 (0.99%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    5
    1
    2
    0
    Swollen Tongue
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Vomiting
         subjects affected / exposed
    24 / 105 (22.86%)
    12 / 101 (11.88%)
    10 / 48 (20.83%)
    4 / 35 (11.43%)
         occurrences all number
    28
    17
    11
    4
    Abdominal Distension
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal Rigidity
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal Tenderness
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anal Discomfort
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epigastric Discomfort
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Frequent Bowel Movements
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lip Dry
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Oesophagitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral Mucosal Blistering
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Oral Mucosal Exfoliation
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth Disorder
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Reflux Oesophagitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatic Pain
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 105 (5.71%)
    1 / 101 (0.99%)
    7 / 48 (14.58%)
    1 / 35 (2.86%)
         occurrences all number
    7
    1
    8
    1
    Acrodermatitis
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Alopecia
         subjects affected / exposed
    51 / 105 (48.57%)
    23 / 101 (22.77%)
    25 / 48 (52.08%)
    5 / 35 (14.29%)
         occurrences all number
    64
    26
    30
    5
    Blister
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Decubitus Ulcer
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Dermatitis Acneiform
         subjects affected / exposed
    5 / 105 (4.76%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    6
    0
    1
    0
    Dermatitis Contact
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Drug Eruption
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dry Skin
         subjects affected / exposed
    26 / 105 (24.76%)
    6 / 101 (5.94%)
    8 / 48 (16.67%)
    1 / 35 (2.86%)
         occurrences all number
    35
    7
    8
    1
    Ecchymosis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    1
    Eczema
         subjects affected / exposed
    4 / 105 (3.81%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    4
    0
    0
    1
    Erythema
         subjects affected / exposed
    12 / 105 (11.43%)
    0 / 101 (0.00%)
    3 / 48 (6.25%)
    0 / 35 (0.00%)
         occurrences all number
    16
    0
    8
    0
    Hair Colour Changes
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Hair Disorder
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hair Growth Abnormal
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hair Texture Abnormal
         subjects affected / exposed
    4 / 105 (3.81%)
    1 / 101 (0.99%)
    3 / 48 (6.25%)
    1 / 35 (2.86%)
         occurrences all number
    5
    1
    3
    1
    Hangnail
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    1
    Hypertrichosis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Ingrowing Nail
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Intertrigo
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Itching Scar
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Nail Disorder
         subjects affected / exposed
    7 / 105 (6.67%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    7
    0
    0
    0
    Nail Growth Abnormal
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Onychoclasis
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    3 / 48 (6.25%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    4
    0
    Onycholysis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palmar Erythema
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Palmar-Plantar Erythrodysaesthesia Syndrome
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    14 / 105 (13.33%)
    12 / 101 (11.88%)
    4 / 48 (8.33%)
    1 / 35 (2.86%)
         occurrences all number
    18
    14
    6
    1
    Pruritus Generalised
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash
         subjects affected / exposed
    52 / 105 (49.52%)
    17 / 101 (16.83%)
    14 / 48 (29.17%)
    2 / 35 (5.71%)
         occurrences all number
    83
    23
    15
    2
    Rash Erythematous
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Rash Generalised
         subjects affected / exposed
    7 / 105 (6.67%)
    0 / 101 (0.00%)
    4 / 48 (8.33%)
    0 / 35 (0.00%)
         occurrences all number
    8
    0
    4
    0
    Rash Macular
         subjects affected / exposed
    4 / 105 (3.81%)
    2 / 101 (1.98%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    5
    2
    1
    0
    Rash Maculo-Papular
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Rash Papular
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Rash Pruritic
         subjects affected / exposed
    8 / 105 (7.62%)
    2 / 101 (1.98%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    9
    2
    2
    0
    Rosacea
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Skin Exfoliation
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Skin Fissures
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    1
    0
    Skin Irritation
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin Lesion
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin Reaction
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Toxicity
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Skin Ulcer
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    1
    1
    Swelling Face
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    5 / 105 (4.76%)
    0 / 101 (0.00%)
    3 / 48 (6.25%)
    0 / 35 (0.00%)
         occurrences all number
    5
    0
    3
    0
    Haematuria
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Chromaturia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pollakiuria
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Urinary Incontinence
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Urinary Bladder Haemorrhage
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 105 (11.43%)
    11 / 101 (10.89%)
    1 / 48 (2.08%)
    3 / 35 (8.57%)
         occurrences all number
    15
    13
    1
    3
    Back Pain
         subjects affected / exposed
    11 / 105 (10.48%)
    9 / 101 (8.91%)
    0 / 48 (0.00%)
    3 / 35 (8.57%)
         occurrences all number
    12
    11
    0
    4
    Bone Pain
         subjects affected / exposed
    7 / 105 (6.67%)
    12 / 101 (11.88%)
    5 / 48 (10.42%)
    4 / 35 (11.43%)
         occurrences all number
    7
    12
    6
    4
    Flank Pain
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Joint Swelling
         subjects affected / exposed
    2 / 105 (1.90%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Muscle Spasms
         subjects affected / exposed
    9 / 105 (8.57%)
    2 / 101 (1.98%)
    9 / 48 (18.75%)
    2 / 35 (5.71%)
         occurrences all number
    12
    2
    10
    4
    Musculoskeletal Chest Pain
         subjects affected / exposed
    4 / 105 (3.81%)
    9 / 101 (8.91%)
    2 / 48 (4.17%)
    1 / 35 (2.86%)
         occurrences all number
    5
    12
    4
    1
    Musculoskeletal Pain
         subjects affected / exposed
    3 / 105 (2.86%)
    4 / 101 (3.96%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    4
    5
    2
    0
    Musculoskeletal Stiffness
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mialgia
         subjects affected / exposed
    9 / 105 (8.57%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    9
    3
    0
    2
    Neck Pain
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Pain In Extremity
         subjects affected / exposed
    4 / 105 (3.81%)
    9 / 101 (8.91%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    10
    0
    0
    Pathological Fracture
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rotator Cuff Syndrome
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sensation Of Heaviness
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Intervertebral Disc Compression
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint Effusion
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Monarthritis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Muscular Weakness
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    1
    Osteoporosis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Synovial Cyst
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Breast Cellulitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    2 / 105 (1.90%)
    4 / 101 (3.96%)
    3 / 48 (6.25%)
    1 / 35 (2.86%)
         occurrences all number
    3
    4
    4
    1
    Cellulitis
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Cystitis
         subjects affected / exposed
    6 / 105 (5.71%)
    1 / 101 (0.99%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    6
    1
    4
    0
    Dermatitis Infected
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ear Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Enterovirus Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Erysipelas
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    1
    6
    Fungal Rash
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fungal Skin Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    0
    1
    Herpes Simplex
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    2 / 105 (1.90%)
    3 / 101 (2.97%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    3
    3
    4
    0
    Laryngitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Localised Infection
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    4 / 105 (3.81%)
    4 / 101 (3.96%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    4
    0
    0
    Nail Infection
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 105 (3.81%)
    4 / 101 (3.96%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    8
    5
    1
    0
    Oesphageal Candidiasis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral Candidiasis
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Oral Herpes
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    2
    0
    0
    1
    Rash Pustular
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    5
    0
    0
    2
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 105 (1.90%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    2
    0
    0
    Urinary Tract Infection
         subjects affected / exposed
    6 / 105 (5.71%)
    5 / 101 (4.95%)
    5 / 48 (10.42%)
    0 / 35 (0.00%)
         occurrences all number
    7
    6
    6
    0
    Vaginal Candidiasis
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    3
    1
    1
    0
    Vaginal Infection
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Wound Infection
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    1
    Fungal Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes Zoster
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    2 / 48 (4.17%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    2
    1
    Lymphangitis
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    3 / 48 (6.25%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    2 / 48 (4.17%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Tooth Abscess
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vulvovaginal Mycotic Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Candidasis
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 101 (1.98%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Breast Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Eye Infection
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    9 / 105 (8.57%)
    3 / 101 (2.97%)
    3 / 48 (6.25%)
    2 / 35 (5.71%)
         occurrences all number
    11
    3
    5
    2
    Decreased Appetite
         subjects affected / exposed
    8 / 105 (7.62%)
    6 / 101 (5.94%)
    1 / 48 (2.08%)
    1 / 35 (2.86%)
         occurrences all number
    8
    6
    1
    1
    Dehydration
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Diabetes Mellitus
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Fluid Retention
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gout
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    1 / 48 (2.08%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypercalcaemia
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypokalaemia
         subjects affected / exposed
    4 / 105 (3.81%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    5
    1
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Increased Appetite
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 101 (0.99%)
    0 / 48 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 101 (0.00%)
    0 / 48 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    0
    1

    More information

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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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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