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    Clinical Trial Results:
    Randomized phase III study of neoadjuvant chemotherapy followed by surgery vs. concomitant radiotherapy and chemotherapy in FIGO Ib2, IIa > 4 cm or IIb cervical cancer.

    Summary
    EudraCT number
    		 2008-003396-52
    Trial protocol
    		 GB   FR  
    Global end of trial date
    29 Nov 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Aug 2022
    First version publication date
    26 Aug 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EORTC55994
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00039338
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    EORTC
    Sponsor organisation address
    Avenue E. Mounier 83/11, Brussels, Belgium, 1200
    Public contact
    Regulatory Affairs Department, European Organisation for Research and Treatment of Cancer, 0032 02 774 10 54, corneel.coens@eortc.org
    Scientific contact
    Regulatory Affairs Department, European Organisation for Research and Treatment of Cancer, 0032 02 774 10 54, corneel.coens@eortc.org
    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
    29 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate an advantage in overall survival with the use of neoadjuvant chemotherapy followed by radical surgery as compared to the standard approach (concomitant chemotherapy and radiotherapy) in FIGO stage Ib2, IIa> 4 cm, IIb cervical cancer patients.
    Protection of trial subjects
    The study is conducted in agreement with the Declaration of Helsinki (available on the World Medical Association web site (http://www.wma.net)) and/or the laws and regulations of the participating countries, whichever provides the greatest protection of the patient. The protocol has been written, and the study conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice. The protocol was approved by the competent ethics committee(s) as required by the applicable national legislation. Safety data were reviewed within the EORTC Headquarters on a regular basis as part of the Medical Review process. Safety information was included in trial status reports which served as a basis of discussion during EORTC Group meetings.
    Background therapy
    		 NA
    Evidence for comparator
    		 Results from 5 randomized phase III trials show an overall survival advantage for cisplatin-based therapy given concurrently with radiation therapy. The patient populations in these studies included women with FIGO stages IB2 to IVA cervical cancer treated with primary radiation therapy and women with FIGO stages Ib to IIA disease found to have poor prognostic factors (metastatic disease in pelvic lymph nodes, disease, or positive surgical margins) at time of primary surgery. Although the trials vary somewhat in terms of stage of disease, dose of radiation, and schedule of cisplatin and radiation, they all demonstrate significant survival benefit for this combined approach. The risk of death from cervical cancer was decreased by 30% to 50% by concurrent chemoradiation. Ref: - Gerstner N, Wachter S, Knocke TH, Fellner C, Wambersie A, Potter R. The benefit of Beam's Eye View based 3D treatment planning for cervical cancer. Radiother. Oncol. 51: 7I-78; 1999. - Girinsky T., Rey A., Roche B., Haie C., Gerbaulet A., Randrianarivello H. Overall treatment time in advanced cervical carcinomas : a critical parameter in treatment outcome. Int. J. Radiat. Oncol. Biol. Phys. 27 : 1051-6 ; 1993. - Lanciano R., Thomas G., Eifel PG. Over 20 years of progression in radiation oncology: Cervical Cancer. Semin Radiat Oncol 7:121-126, 1997. - Nag S, Erickson B, Thomadsen B, Orton C, Demanes JD, Petereit D: the American Brachytherapy Society recommendations for High Dose Rate brachytherapy for carciunoma of the Cervix. - Perez CA, Grigsby PW, Castro Vita H, Lockett MA. Carcinoma of the uterine cervix. I. Impact of prolongation of overall treatment time and timing of brachytherapy on outcome of radiation therapy. Int J Radiat Oncol Biol Phys 32:1275-1288, 1995.
    Actual start date of recruitment
    25 May 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 188
    Country: Number of subjects enrolled
    Netherlands: 182
    Country: Number of subjects enrolled
    Belgium: 80
    Country: Number of subjects enrolled
    Poland: 56
    Country: Number of subjects enrolled
    United Kingdom: 48
    Country: Number of subjects enrolled
    Spain: 36
    Country: Number of subjects enrolled
    Portugal: 24
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Norway: 4
    Country: Number of subjects enrolled
    France: 2
    Worldwide total number of subjects
    626
    EEA total number of subjects
    578
    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)
    570
    From 65 to 84 years
    56
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 According to the protocol, it was planned to recruit 625 patients in total. A total of 626 patients were randomized between 23/05/2002 and 22/01/2014 (11 years and 8 months; 140 months) by 25 institutions from 10 countries to receive either NACT followed by surgery (N=314) or concomitant chemo-radiation (N=312).

    Pre-assignment
    Screening details
    		 Cervical cancer of squamous or adeno(squamous) cell type FIGO stage Ib2, IIa2>4cm or IIb, WHO performance status 0-2, 18-75 years of age, no prior irradiation or chemotherapy, adequate laboratory values and written informed consent according to ICH/GCP and national/local regulations.

    Period 1
    Period 1 title
    Randomization (overall study period) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Central randomisation using minimization stratified for institution, FIGO stage, age (18-50; 51-75), histological subtype (adenomatous vs non- adenomatous component). Patients are randomized to receive either neoadjuvant chemotherapy followed by surgery (Arm I) or concomitant chemotherapy and radiotherapy (Arm II, control group) in 1:1 ratio.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NACTS
    Arm description
    		 In the NACTS arm, chemotherapy consisted of cisplatin-based chemotherapy. Several chemotherapy regimens were allowed according to the policy of the institute. The minimum cumulative cisplatin dose was set at 225 mg/m² with a minimum dose of cisplatin of 75 mg/m² per 3 weeks, irrespectively whether cycles were scheduled weekly or over 10 or 21 days, thus reflecting the daily practice of the majority of the centers. Radical hysterectomy was required within 6 weeks after completion of neoadjuvant chemotherapy and consisted of a Piver-Rutledge type III-V radical hysterectomy, with lymphadenectomy of pelvic-infra-mesenteric with or without high para-aortal lymph nodes).
    Arm type
    		 standard of care

    Investigational medicinal product name
    cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The minimum cumulative cisplatin dose should be 225 mg/m2 (except when dose modifications, dose delays or treatment termination are needed). The cisplatin dose should be the equivalent of at least 25 mg/m2 per week. The final dose to start no later than day 64.

    Arm title
    		 CCRT
    Arm description
    		 In the CCRT (concomitant chemoradiotherapy) arm cisplatin was to be given with 5 or 6 weekly doses of 40 mg/m2 during radiotherapy. External beam radiotherapy with a dose between 45-50 Gy was given to the pelvis combined with external boost or brachytherapy. A minimal total dose (external radiotherapy with or without external boost + brachytherapy) of 75 Gy EQD2 to point A (or 80 Gy to high risk PTV) was mandatory. Adjuvant hysterectomy was allowed in case of histologically proven residual tumour.
    Arm type
    		 standard of care

    Investigational medicinal product name
    cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Concomitant chemotherapy with an initial dose of at least 40 mg/m2 cisplatin will be administered weekly with a maximum dose of 80 mg per administration and a maximum of 6 administrations. The chemotherapy must be given weekly during radiotherapy. The total cumulative dose should be between 200-240 mg/m² (except when dose modifications, dose delays or treatment termination are allowed by the protocol).

    Number of subjects in period 1
    		NACTS CCRT
    Started
    314
    312
    Completed
    223
    257
    Not completed
    91
    55
         Patient refusal
    10
    13
         Organizational problems
    -
    2
         Physician decision
    3
    6
         Consent withdrawn by subject
    -
    2
         Toxicity + lack of efficacy
    1
    -
         Adverse event, non-fatal
    31
    23
         RTP finished early
    -
    1
         Toxicity + patient refusal
    -
    1
         surgical contraindication
    4
    -
         Progressive disease
    21
    1
         Protocol deviation
    7
    6
         Lack of efficacy
    14
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NACTS
    Reporting group description
    		 In the NACTS arm, chemotherapy consisted of cisplatin-based chemotherapy. Several chemotherapy regimens were allowed according to the policy of the institute. The minimum cumulative cisplatin dose was set at 225 mg/m² with a minimum dose of cisplatin of 75 mg/m² per 3 weeks, irrespectively whether cycles were scheduled weekly or over 10 or 21 days, thus reflecting the daily practice of the majority of the centers. Radical hysterectomy was required within 6 weeks after completion of neoadjuvant chemotherapy and consisted of a Piver-Rutledge type III-V radical hysterectomy, with lymphadenectomy of pelvic-infra-mesenteric with or without high para-aortal lymph nodes).

    Reporting group title
    CCRT
    Reporting group description
    		 In the CCRT (concomitant chemoradiotherapy) arm cisplatin was to be given with 5 or 6 weekly doses of 40 mg/m2 during radiotherapy. External beam radiotherapy with a dose between 45-50 Gy was given to the pelvis combined with external boost or brachytherapy. A minimal total dose (external radiotherapy with or without external boost + brachytherapy) of 75 Gy EQD2 to point A (or 80 Gy to high risk PTV) was mandatory. Adjuvant hysterectomy was allowed in case of histologically proven residual tumour.

    Reporting group values
    		 NACTS CCRT Total
    Number of subjects
    		 314 312 626
    Age categorical
    Age
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 287 283 570
        From 65-84 years
    		 27 29 56
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 46 (23 to 73) 47 (23 to 75) -
    Gender categorical
    Gender
    Units: Subjects
        Female
    		 314 312 626
        Male
    		 0 0 0
    WHO PS
    WHO performance status
    Units: Subjects
        PS 0
    		 277 273 550
        PS 1
    		 36 39 75
        Unknown
    		 1 0 1
    Type of cervical carcinoma
    Histological type of the cervical carcinoma
    Units: Subjects
        squamous
    		 266 264 530
        adenosquamous
    		 16 11 27
        adenocarcinoma
    		 31 35 66
        clear cell
    		 0 1 1
        Unknown
    		 0 1 1
        Missing
    		 1 0 1
    FIGO stage
    FIGO stage
    Units: Subjects
        Ib2
    		 83 86 169
        IIa > 4 cm
    		 48 47 95
        IIb
    		 179 178 357
        III
    		 3 0 3
        IV
    		 0 1 1
        Missing
    		 1 0 1
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomized subjects according to allocated arm

    Subject analysis sets values
    		 ITT
    Number of subjects
    626
    Age categorical
    Age
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    570
        From 65-84 years
    56
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Gender
    Units: Subjects
        Female
    626
        Male
    0
    WHO PS
    WHO performance status
    Units: Subjects
        PS 0
        PS 1
        Unknown
    Type of cervical carcinoma
    Histological type of the cervical carcinoma
    Units: Subjects
        squamous
        adenosquamous
        adenocarcinoma
        clear cell
        Unknown
        Missing
    FIGO stage
    FIGO stage
    Units: Subjects
        Ib2
        IIa > 4 cm
        IIb
        III
        IV
        Missing

    End points

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    End points reporting groups
    Reporting group title
    NACTS
    Reporting group description
    		 In the NACTS arm, chemotherapy consisted of cisplatin-based chemotherapy. Several chemotherapy regimens were allowed according to the policy of the institute. The minimum cumulative cisplatin dose was set at 225 mg/m² with a minimum dose of cisplatin of 75 mg/m² per 3 weeks, irrespectively whether cycles were scheduled weekly or over 10 or 21 days, thus reflecting the daily practice of the majority of the centers. Radical hysterectomy was required within 6 weeks after completion of neoadjuvant chemotherapy and consisted of a Piver-Rutledge type III-V radical hysterectomy, with lymphadenectomy of pelvic-infra-mesenteric with or without high para-aortal lymph nodes).

    Reporting group title
    CCRT
    Reporting group description
    		 In the CCRT (concomitant chemoradiotherapy) arm cisplatin was to be given with 5 or 6 weekly doses of 40 mg/m2 during radiotherapy. External beam radiotherapy with a dose between 45-50 Gy was given to the pelvis combined with external boost or brachytherapy. A minimal total dose (external radiotherapy with or without external boost + brachytherapy) of 75 Gy EQD2 to point A (or 80 Gy to high risk PTV) was mandatory. Adjuvant hysterectomy was allowed in case of histologically proven residual tumour.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomized subjects according to allocated arm

    Primary: Overall survival at year 5

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    End point title
    		 Overall survival at year 5
    End point description
    The main endpoint of the study is the overall survival rate at 5 years. Overall survival is computed from the date of patient randomization to the date of death (any cause) or date of last known to be alive for each patient. The 5 year survival rate is derived using KM estimation.
    End point type
    Primary
    End point timeframe
    5 years after randomization
    End point values
    		 NACTS CCRT
    Number of subjects analysed
    314
    312
    Units: percentage alive
        number (confidence interval 95%)
    71.7 (66.2 to 76.5)
    75.5 (70.2 to 80.0)
    Statistical analysis title
    		 OS difference at year 5
    Comparison groups
    NACTS v CCRT
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.291
    Method
    		 Chi-squared
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 10.7
    Statistical analysis title
    		 OS logrank test
    Statistical analysis description
    Logrank test of OS
    Comparison groups
    NACTS v CCRT
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.24
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 1.12

    Secondary: PFS at year 5

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    End point title
    		 PFS at year 5
    End point description
    End point type
    Secondary
    End point timeframe
    overall study duration
    End point values
    		 NACTS CCRT
    Number of subjects analysed
    314
    312
    Units: percentage alive wo PD
        number (confidence interval 95%)
    57.0 (51.1 to 62.4)
    65.6 (59.9 to 70.7)
    Statistical analysis title
    		 PFS logrank test
    Comparison groups
    NACTS v CCRT
    Number of subjects included in analysis
    626
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.93

    Secondary: Complete response

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    End point title
    		 Complete response
    End point description
    complete response versus (partial response, stable disease, progressive disease, non-evaluable)
    End point type
    Secondary
    End point timeframe
    Best response to chemotherapy: best response recorded taking into account all tumor assessments during and after protocol treatment for a maximum of 8 weeks after last chemotherapy or radiotherapy administration.
    End point values
    		 NACTS CCRT
    Number of subjects analysed
    314
    312
    Units: Subjects
    54
    138
    No statistical analyses for this end point

    Secondary: Response

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    End point title
    		 Response
    End point description
    complete and partial response versus (stable disease, progressive disease, non-evaluable) according to RECIST.
    End point type
    Secondary
    End point timeframe
    Best response to chemotherapy: best response recorded taking into account all tumor assessments during and after protocol treatment for a maximum of 8 weeks after last chemotherapy or radiotherapy administration.
    End point values
    		 NACTS CCRT
    Number of subjects analysed
    314
    312
    Units: Subjects
    185
    206
    No statistical analyses for this end point

    Secondary: Health-related Quality of Life

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    End point title
    		 Health-related Quality of Life
    End point description
    Descriptive analysis of the overall health scale (GHQ) of the QLQ-C30
    End point type
    Secondary
    End point timeframe
    QLQ-C30 questionnaires collected at baseline, month 6, month 12, month 18 and month 24
    End point values
    		 NACTS CCRT
    Number of subjects analysed
    229 [1]
    200 [2]
    Units: QLQ-C30 points
    median (inter-quartile range (Q1-Q3))
        month 6
    75 (58 to 83)
    67 (67 to 83)
        month 12
    75 (58 to 83)
    75 (58 to 83)
        month 18
    67 (58 to 83)
    75 (58 to 83)
        month 24
    83 (58 to 92)
    71 (67 to 83)
    Notes
    [1] - limited to randomized patients with at least one valid questionnaire completed.
    [2] - limited to randomized patients with at least one valid questionnaire completed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 8 weeks after end of protocol treatment. Long term complications were collected until year 5 or progression/start of new treatment.
    Adverse event reporting additional description
    Adverse events were collected up to 8 weeks after end of protocol treatment. In addition, long term complication were assessed every 3 months during the year 1 and every 6 months during years 2 until 5. Long term evaluation was also stopped upon progression or start of further antitumoral treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    NACTS
    Reporting group description
    		 All 300 patients randomized to the NACTS arm that started allocated treatment regardless of eligibility.

    Reporting group title
    CCRT
    Reporting group description
    		 All 300 patients randomized to the CCRTarm that started allocated treatment regardless of eligibility.

    Serious adverse events
    		 NACTS CCRT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    59 / 300 (19.67%)
    32 / 291 (11.00%)
         number of deaths (all causes)
    102
    82
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    INTRADUCTAL PROLIFERATIVE BREAST LESION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TUMOUR HAEMORRHAGE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    DEEP VEIN THROMBOSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTENSION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALAISE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE ORGAN DYSFUNCTION SYNDROME
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OBSTRUCTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    3 / 300 (1.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    HYPERSENSITIVITY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    SOCIAL PROBLEM
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    VAGINAL HAEMORRHAGE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    HYPOXIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    ANXIETY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    ELECTROCARDIOGRAM QT PROLONGED
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    GASTROENTERITIS RADIATION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL URINE LEAK
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RADIATION SKIN INJURY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETERIC INJURY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND EVISCERATION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FLUTTER
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRADYCARDIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS TACHYCARDIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBRAL HAEMORRHAGE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CEREBRAL ISCHAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERALISED TONIC-CLONIC SEIZURE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARTIAL SEIZURES
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PETIT MAL EPILEPSY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPERIOR SAGITTAL SINUS THROMBOSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WERNICKE'S ENCEPHALOPATHY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DISSEMINATED INTRAVASCULAR COAGULATION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    FEBRILE NEUTROPENIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    5 / 300 (1.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    5 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCYTOPENIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONSTIPATION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    6 / 300 (2.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    7 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    14 / 300 (4.67%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    20 / 20
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL HAEMORRHAGE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGITIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS ACUTE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCTALGIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETROPERITONEAL HAEMATOMA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STOMATITIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    13 / 300 (4.33%)
    4 / 291 (1.37%)
         occurrences causally related to treatment / all
    13 / 13
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    RASH
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URTICARIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    4 / 300 (1.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC KIDNEY DISEASE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDRONEPHROSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHROPATHY
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL IMPAIRMENT
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL TUBULAR NECROSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY RETENTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYALGIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    DEVICE RELATED INFECTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED SEPSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERYSIPELAS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA SEPSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED LYMPHOCELE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SALMONELLOSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUSITIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STREPTOCOCCAL INFECTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STREPTOCOCCAL SEPSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    3 / 300 (1.00%)
    3 / 291 (1.03%)
         occurrences causally related to treatment / all
    0 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROSEPSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DECREASED APPETITE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    3 / 300 (1.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROLYTE IMBALANCE
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERCALCAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOCALCAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    4 / 300 (1.33%)
    2 / 291 (0.69%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOMAGNESAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATRAEMIA
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACTIC ACIDOSIS
    alternative dictionary used: MedDRA 20
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NACTS CCRT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    298 / 300 (99.33%)
    279 / 291 (95.88%)
    Surgical and medical procedures
    BLADDER AND URETHRA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    121 / 300 (40.33%)
    134 / 291 (46.05%)
         occurrences all number
    338
    375
    BONE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    20 / 300 (6.67%)
    23 / 291 (7.90%)
         occurrences all number
    31
    36
    COLON (NON SIGMOID)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    30 / 300 (10.00%)
    47 / 291 (16.15%)
         occurrences all number
    41
    98
    CUTANEOUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    26 / 300 (8.67%)
    30 / 291 (10.31%)
         occurrences all number
    44
    41
    HEMOPOIETIC TISSUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    12 / 300 (4.00%)
    9 / 291 (3.09%)
         occurrences all number
    16
    16
    NON SPECIFIC ABDOMINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    91 / 300 (30.33%)
    92 / 291 (31.62%)
         occurrences all number
    214
    190
    PELVIC SOFT TISSUES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    39 / 300 (13.00%)
    36 / 291 (12.37%)
         occurrences all number
    60
    76
    PERIPHERAL NERVES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    54 / 300 (18.00%)
    39 / 291 (13.40%)
         occurrences all number
    106
    82
    RECTUM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    56 / 300 (18.67%)
    102 / 291 (35.05%)
         occurrences all number
    101
    260
    SIGMOID COLON
    alternative dictionary used: CTC 2
         subjects affected / exposed
    38 / 300 (12.67%)
    72 / 291 (24.74%)
         occurrences all number
    74
    163
    SMALL BOWEL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    26 / 300 (8.67%)
    44 / 291 (15.12%)
         occurrences all number
    42
    91
    STOMACH AND DUODENUM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    35 / 300 (11.67%)
    38 / 291 (13.06%)
         occurrences all number
    47
    47
    URETER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    34 / 300 (11.33%)
    30 / 291 (10.31%)
         occurrences all number
    79
    77
    UTERUS-VAGINA-VULVA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    94 / 300 (31.33%)
    157 / 291 (53.95%)
         occurrences all number
    263
    598
    VESICULAR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    31 / 300 (10.33%)
    12 / 291 (4.12%)
         occurrences all number
    84
    29
    General disorders and administration site conditions
    ASTHENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    11 / 300 (3.67%)
    18 / 291 (6.19%)
         occurrences all number
    14
    28
    CHILLS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    COLD FEET
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    COMMON MALAISE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    COMMON UNWELLNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    FAGIGUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    FATIGUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    124 / 300 (41.33%)
    130 / 291 (44.67%)
         occurrences all number
    337
    307
    FEVER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    30 / 300 (10.00%)
    12 / 291 (4.12%)
         occurrences all number
    37
    14
    FLU
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    FLUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GENERAL FATIGUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GENERAL UNWELLNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEAVY LEGS/TIRED LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HOT FLASHES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    LETHARGY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    LOCAL COMPLAINTS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MALAISE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    5 / 300 (1.67%)
    3 / 291 (1.03%)
         occurrences all number
    8
    7
    MALAISE GENERAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    NIGHT SWEATING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    1 / 291 (0.34%)
         occurrences all number
    4
    1
    NIGHT SWEATS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SHIVERING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SWEATING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    4 / 291 (1.37%)
         occurrences all number
    3
    4
    WEAKNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    1 / 291 (0.34%)
         occurrences all number
    3
    1
    WEIGHT GAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    WEIGHT LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    6 / 300 (2.00%)
    10 / 291 (3.44%)
         occurrences all number
    8
    10
    BILATERAL ANKLE EDEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ELECTROLYTE DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GENERAL CONDITION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GENERAL DETERIORATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MULTI-ORGAN FAILURE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PERIODONTITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RADIATION CYSTITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SMALL SWELLING LEFT HIP, LIPOMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ABDOMIANL CRAMPS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ABDOMINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL CRAMPING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ABDOMINAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    8 / 291 (2.75%)
         occurrences all number
    3
    13
    ACHE BOWELS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ANAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    3 / 291 (1.03%)
         occurrences all number
    1
    3
    ANAL REGION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    BACK PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    5 / 300 (1.67%)
    7 / 291 (2.41%)
         occurrences all number
    6
    12
    ARTHRALGIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    33 / 300 (11.00%)
    24 / 291 (8.25%)
         occurrences all number
    48
    39
    BACKPAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    CERVICAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CHEST PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    COCCYX PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    COSTA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CRAMPS IN LEGS AND TOES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DYSPAREUNIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    4 / 291 (1.37%)
         occurrences all number
    1
    4
    EPIGASTRIC PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    3 / 291 (1.03%)
         occurrences all number
    1
    4
    FROZEN SHOULDER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GROIN PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HYPOCHONDRIUM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEAD ACHE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    25 / 300 (8.33%)
    9 / 291 (3.09%)
         occurrences all number
    32
    12
    INGUINAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    HYPOGASTRIC PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    LEFT SIDE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LOWER ABDOMEN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LOWER ABDOMINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LOWER BACK PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    MICTALGIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    MYALGIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    36 / 300 (12.00%)
    12 / 291 (4.12%)
         occurrences all number
    51
    22
    N.O.S.
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    NECK PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    NEUROPATHIC: NERVUS ISCHIATICUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    5 / 300 (1.67%)
    2 / 291 (0.69%)
         occurrences all number
    7
    4
    PAIN ABDOMEN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN ANAL REGION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN ASS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN BACK
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    4
    2
    PAIN BACK & LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN BUTTOCK RI BY WALKING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN DURING URINATING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN EAR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN GROIN REGION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN HEAD
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    PAIN IN ABDOMEN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    PAIN IN ANAL REGION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN IN GROIN/PUBIC AREA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN IN HAND, TOES, FEET
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN IN THE GENITAL REGION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN IN THE GROIN REGION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN IN VAGINA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN INGUINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    PAIN LEFT FOSSA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN LEFT FOSSA + SACCO-ILIACAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN LEFT GROIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    PAIN LEFT HIP/BUTTOCK
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN LEFT SIDE ABDOMEN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN LEFT UPPER LEG
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN LEFT UPPERARM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN LOWER BACK
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    2
    PAIN LOWER ABDOMEN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 291 (0.69%)
         occurrences all number
    1
    3
    PAIN NERVES UNDERLEGS (NEUROPATHIC PAIN)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN NECK
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    PAIN NOS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    4
    6
    PAIN PERINEUM AREA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN PELVIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN RIGHT FOSSA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    3
    PAIN RECTAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN RIGHT HIP
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN RIGHT LEG
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    PAIN RIGHT SHOULDER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN STOMACH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN SKIN ABDOMINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN VULVA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN VAGINA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAIN WHOLE BODY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    PAIN, NOT DEFINIED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PELVIC PAIN BACK PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PELVIC PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    3
    1
    PELVIC PAINS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PELVIS AND GROIN PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RECTAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    3
    RECTAL PAIN (ULCER)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RENAL COLICS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    RIGHT FLANK PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RIGHT ARM PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SKIN SURFACE PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SORE THROAT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    STOMACH ACHE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    STOMACH PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    SUPRA PUBIC PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    SUPRAPUBIC PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SWALLOWING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    THORACAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    THORACIC PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    THROAT PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    TUMOR PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    UNSPECIFIED PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL AND GROIN PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL EXAMINATION PAINFUL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    3
    4
    VULVAR PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    COMMON COLD
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    FLU ILLNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    FLU LIKE SYNDROME
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    FLU-LIKE FEELING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    FLU-LIKE SYMPTOMS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEAVY LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    5
    0
    Immune system disorders
    ALLERGY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    33 / 300 (11.00%)
    21 / 291 (7.22%)
         occurrences all number
    40
    27
    URTICARIIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    FISSURE VAGINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    IRREGULAR MENSES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ITCH VAGINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MUC DISCHARGE UTEROUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    MUCOSITIS PORTIO/VAGINA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PURULENT PV DISCHARGE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RADIATION EFFECTS VAGINA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SCARTISSUE VAGINA DUE RT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SIGNS OF AMENORRHEA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SYNECHIA VAGINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINA AND VULVODYNIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    BLEEDING VAGINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL BLOOD LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL BURNING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    VAGINAL DISCHARGES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    VAGINAL DISCOMFORT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL DRYNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL FLUID LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    3 / 291 (1.03%)
         occurrences all number
    0
    3
    VAGINAL ITCHING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL NARROWING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL PRURUITUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL PRURITUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    VULVAR EDEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VULVITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VULVAR WOUND
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    COLD (COMMON)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    A COUGH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    COUGH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    18 / 300 (6.00%)
    9 / 291 (3.09%)
         occurrences all number
    26
    11
    DYSPNEA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    15 / 300 (5.00%)
    15 / 291 (5.15%)
         occurrences all number
    23
    18
    HOARSENESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HYPERVENTILATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LABORED BREATHING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PULMONARY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    13 / 300 (4.33%)
    4 / 291 (1.37%)
         occurrences all number
    18
    5
    PULMONARY EMBOLISM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    2
    Cardiac disorders
    BRADYCARDIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    CARDIOVASCULAR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    24 / 300 (8.00%)
    16 / 291 (5.50%)
         occurrences all number
    36
    23
    DEEP VEIN THROMBOSISI LEFT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DVT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    EDEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    27 / 300 (9.00%)
    10 / 291 (3.44%)
         occurrences all number
    31
    12
    HEART PALPITATIONS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HYPERTENSION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    23 / 300 (7.67%)
    7 / 291 (2.41%)
         occurrences all number
    65
    17
    HYPOTENSION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    6 / 300 (2.00%)
    7 / 291 (2.41%)
         occurrences all number
    6
    7
    PALPITATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PALPITATIONS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    PHLEBITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 291 (0.69%)
         occurrences all number
    1
    2
    PROLONGED QTC INTERVAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    REPOLARISATION DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    TACHYCARDIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    THROMBOSIS AT SINUS SIGMOID
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    THROMBOSIS LEFT UPPERARM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    THROMBOSIS PICC CATHETER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    THROMBOSIS/EMBOLISM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    ANXIETY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    BALANCE DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DEAD FEELING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DEJECTED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DEPRESSION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DISTRESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    DIZZINESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    5 / 300 (1.67%)
    5 / 291 (1.72%)
         occurrences all number
    5
    5
    DIZZY, FAINTING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    EMOTIONAL DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    2 / 291 (0.69%)
         occurrences all number
    3
    2
    FORGETFUL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HALLUCINATIONS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEADACHE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INSOMNIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    2
    LIGHT HEADINESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MENTAL DISTRESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    MOOD ALTERATION - ANXIETY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MOOD ALTERATION AGITATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MOOD ALTERATION: EMOTIONAL DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    NERVOSITAS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    1 / 291 (0.34%)
         occurrences all number
    3
    1
    NEUROLOGY-OTHER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    39 / 300 (13.00%)
    27 / 291 (9.28%)
         occurrences all number
    79
    37
    NEUROPATHY-MOTOR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    NEUROPATHY-SENSORY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    62 / 300 (20.67%)
    41 / 291 (14.09%)
         occurrences all number
    110
    59
    NUMBNESS GROIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    NUMBNESS L HIP
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PANIC ATTACKS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PETIT MAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    RESTLESS LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    SENSATION FULLNESS HEAD
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SLEEP DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    SOCIAL PROBLEMS (AT HOME)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    TREMOR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    UNSTABLE LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    WERNICKE ENCEPHALOPATHY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    ALAT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    ANEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    19 / 300 (6.33%)
    11 / 291 (3.78%)
         occurrences all number
    35
    18
    ASAT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    CREATININE ELEVATED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GRANULOCYTOPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEMATOLOGICAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEMOGLOBIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    69 / 300 (23.00%)
    51 / 291 (17.53%)
         occurrences all number
    103
    114
    HYPOMAGNESEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LEUCOPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    14 / 300 (4.67%)
    7 / 291 (2.41%)
         occurrences all number
    21
    11
    LEUKOCYTES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    LYMPHOPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    6
    NEUTROPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    24 / 300 (8.00%)
    9 / 291 (3.09%)
         occurrences all number
    35
    12
    NEUTROPHILS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    31 / 300 (10.33%)
    21 / 291 (7.22%)
         occurrences all number
    35
    22
    NEUTROPHILS/GRANULOCYTES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    3 / 291 (1.03%)
         occurrences all number
    6
    4
    PANCYTOPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    2
    PLATELETS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    4 / 300 (1.33%)
    7 / 291 (2.41%)
         occurrences all number
    5
    9
    THROMBOCYTOPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    11 / 300 (3.67%)
    5 / 291 (1.72%)
         occurrences all number
    17
    7
    TROMBOCYTOPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 291 (0.69%)
         occurrences all number
    1
    3
    DISSEMINATED INTRAVASCULAR COAGULATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ABDOMINAL HEMATOMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    73 / 300 (24.33%)
    0 / 291 (0.00%)
         occurrences all number
    73
    0
    BLOOD LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    EPISTAXIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    4 / 300 (1.33%)
    0 / 291 (0.00%)
         occurrences all number
    8
    0
    ESOPHAGAL BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEMATOMA NAVEL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEMATOMA RETRO PERITONEAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HEMATURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    3 / 291 (1.03%)
         occurrences all number
    3
    4
    HEMORRHAGE/BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    IRREGULAR BLOOD LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    NOSE BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    BLEEDING RECTAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    UTERINE BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    VAGINAL BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    25 / 300 (8.33%)
    51 / 291 (17.53%)
         occurrences all number
    32
    79
    Ear and labyrinth disorders
    AUDITORY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    59 / 300 (19.67%)
    35 / 291 (12.03%)
         occurrences all number
    139
    66
    HEARING LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    INNER EAR/HEARING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    1 / 291 (0.34%)
         occurrences all number
    4
    1
    Eye disorders
    AMBLYOPIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    BLURRED VISION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    BLURRED VISION LEFT EYE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    CONJUNCTIVIS LEFT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    CONJUNCTIVITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    DECLINE VISUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DOUBLE VISION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DOUBLE VISION - PAPILLEDEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DRY EYES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    4
    HAZY SIGHT (SEEING(?))
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    INTRA-OCULAR PRESSURE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    OPTIC DISC EDEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VISION LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    VISION:FLASHING LIGHTS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    VISUAL DISTURBANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    VISUS DECREASE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN ABDOMINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    79 / 300 (26.33%)
    89 / 291 (30.58%)
         occurrences all number
    137
    147
    ACUTE PANCREATITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    ALTERED TASTE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    ANOREXIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    9 / 291 (3.09%)
         occurrences all number
    3
    12
    CONSTIPATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    121 / 300 (40.33%)
    78 / 291 (26.80%)
         occurrences all number
    212
    114
    DECREASED APPETITE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    3
    1
    DEHYDRATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DEHYDRATIONDRY SKIN AND MUCOSA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DIARRHEA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    64 / 300 (21.33%)
    191 / 291 (65.64%)
         occurrences all number
    91
    398
    DISGEUSIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DRY MOUTH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DYSGEUSIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    DYSOSMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DYSPEPSIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    DYSPEPSIA/HEARTBURN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    DYSPHAGIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    FLATULENCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    GASTROINTESTINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    100 / 300 (33.33%)
    81 / 291 (27.84%)
         occurrences all number
    193
    145
    GASTROINTESTINAL HEMOROÏDS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ILEUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    LOSS OF APPETITE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MUCOSITIS ANAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    MUCOSITIS ORAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    MUCOSITIS/STOMATITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    NASTY TASTE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    NAUSEA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    220 / 300 (73.33%)
    173 / 291 (59.45%)
         occurrences all number
    466
    397
    ODYNOPHAGIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    OESOPHAGITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    OLFACTORY LOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    OPERATIVE INJURY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ORAL CAVITY MUCOSITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ORAL MUCOSITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PHARYNGAL - MUCOSITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PHARYNGITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PYROSIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    RECTAL BLEEDING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    7 / 300 (2.33%)
    7 / 291 (2.41%)
         occurrences all number
    8
    7
    RUCTUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    SENSE OF SMELL DISTURBANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    2 / 291 (0.69%)
         occurrences all number
    3
    3
    SENSE OF TASTE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    STOMACH DISTURBANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    STOMACH ULCERATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    STOMATITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    3
    3
    TASTE DISTURBANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    2
    VOMITING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    132 / 300 (44.00%)
    89 / 291 (30.58%)
         occurrences all number
    218
    151
    LOSS OF WEIGHT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    Hepatobiliary disorders
    ALAT VALUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    5
    4
    ALKALINE PHOSPHATASIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ALT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ASAT VALUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    4
    2
    BILIRUBIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    11 / 300 (3.67%)
    31 / 291 (10.65%)
         occurrences all number
    15
    58
    GGT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    4
    6
    GGT INCREASED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HYPERTRANSAMINASE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    3 / 291 (1.03%)
         occurrences all number
    1
    4
    HYPOKALEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INCREASE OF CRP
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INCREASE OF GAMMA GT-LEVEL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INCREASED LIVER ENZYMES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LDH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LIVER DYSFUNCTION/FAILURE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    LIVER FUNCTION (ASAT/ALAT)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    SGOT (AST)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    23 / 300 (7.67%)
    29 / 291 (9.97%)
         occurrences all number
    28
    45
    SGPT (ALT)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    21 / 300 (7.00%)
    44 / 291 (15.12%)
         occurrences all number
    27
    79
    Skin and subcutaneous tissue disorders
    ABDOMINAL WOUND
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ACNE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ALLOPECIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ALOPECIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    82 / 300 (27.33%)
    13 / 291 (4.47%)
         occurrences all number
    164
    17
    BURN BACKSIDE/GROIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    CUTANEOUS-RASH REACTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DECUBITUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DERMATITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DESQUAMATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    DIASTHASIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DRY SKIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    5 / 300 (1.67%)
    4 / 291 (1.37%)
         occurrences all number
    9
    5
    ECZEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    2
    EPIDERMIOLYSIS LABIA/PERIANAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ERYTHEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    EXANTHEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    EXCORIATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    FLUSHING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HAIRLOSS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HAND-FOOT REACTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    HYPERPIGMENTATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    INGUINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    INJECTION SITE REACTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    IRRITATION OF THE BACK
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ITCHING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    ITCHY SKIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    NAIL CHANGES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    3
    PIGMENTATION CHANGES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    PRURITUS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    4 / 291 (1.37%)
         occurrences all number
    1
    4
    PSORIASIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    RADIATION DERMATITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    RADIATION DERMATITIS VULVAR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RASH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    4 / 291 (1.37%)
         occurrences all number
    4
    6
    RASH/DESQUAMATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    SKIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SKIN DRY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    SKIN PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SKIN RADIATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    SKIN RASH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    7 / 300 (2.33%)
    10 / 291 (3.44%)
         occurrences all number
    11
    12
    SKIN REACTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SKIN REDNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    URTICARIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VITILIGO LOWER LEGS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    VULVA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    WOUND CELLULITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    WOUND DEHISCENCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    WOUND FINGER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    WOUND INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    WOUND PROBLEM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    ACUTE PRERENAL FAILURE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ACUTE RENAL INSUFFICIENCY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    URETHRA AND BLADDER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CREATINE ELEVATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    BLADDER DYSFUNCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CREATININE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    12 / 300 (4.00%)
    3 / 291 (1.03%)
         occurrences all number
    16
    8
    CREATININE CLEARANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    CREATININE CLEARANCE DECREASE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    CREATININE ELEVATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CREATININE INCREASE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    4 / 300 (1.33%)
    0 / 291 (0.00%)
         occurrences all number
    4
    0
    CYSTITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    4 / 300 (1.33%)
    9 / 291 (3.09%)
         occurrences all number
    4
    12
    CREATININE INCREASED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DECREASED RENAL FUNCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DECLINE OF RENAL FUNCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DEHISCENCE OF VAGINAL CUFF SURGICAL REPAIR
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DYSURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    32 / 291 (11.00%)
         occurrences all number
    0
    47
    DIFFICULTY URINATING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    DYSURIA (PAINFUL URINATION)
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ELECTROLYTE DISTURBANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    FISTULA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    ERYTHEMA GENITALIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HYDRONEPHROSIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HYDRO-URETERO-NEPHROSIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    INCONTINENCY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    INCONTINENCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    1
    INCREASE CREATININE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INCREASED CREATININE VALUE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INCREASED CREATININE LEVEL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    KIDNEY FAILURE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    INJURY TO URETER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    KIDNEY FUNCTION DECREASE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    MICTALGIA PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MICTURATION PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    4
    MUCOSITIS CERVIX
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    MUCOSITIS VAGINAL
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    NEPHROPATHY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    NOCTURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    NYCTURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 291 (0.69%)
         occurrences all number
    2
    3
    OPERATION INJURY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    10 / 300 (3.33%)
    0 / 291 (0.00%)
         occurrences all number
    10
    0
    OPERATIVE INJURY TO URETER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PAIN + DYSURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    PAINFUL URINATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    2 / 291 (0.69%)
         occurrences all number
    0
    2
    POLLAKISURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    4 / 291 (1.37%)
         occurrences all number
    1
    5
    PRE-RENAL KIDNEY DISTURBANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RADIATION VULVO VAGINITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RADIOCYSTISIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    RENAL CLEARANCES REDUCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RENAL FUNCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RENAL FUNCTION DECREASING
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RENAL IMPAIRMENT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RENAL INSUFFICIENCY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    3 / 300 (1.00%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    RIGHT URETER LEAKAGE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SENSITIVE BLADDER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    STRESS INCONTINENCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    2 / 291 (0.69%)
         occurrences all number
    1
    2
    SUPRAPUBIC CATHETER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    URETERAL OBSTRUCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    URGE INCONTINENCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    4 / 291 (1.37%)
         occurrences all number
    2
    5
    URGENCY OF MICTURITION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    URINARY DISTURBANCES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    URINARY FREQUENCE INCREASE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    URINARY FREQUENCY
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    5 / 291 (1.72%)
         occurrences all number
    1
    6
    URINARY FREQUENCY NOCTURIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    URINARY INCONTINENCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    URINARY OBSTRUCTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    URINARY RETENTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    12 / 300 (4.00%)
    2 / 291 (0.69%)
         occurrences all number
    16
    2
    URINARY TRACT INFECTED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    UTERUS PERFORATION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL DISCHARGE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    3
    2
    VAGINAL ITCH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINAL WARTS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    VAGINITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    3 / 291 (1.03%)
         occurrences all number
    0
    3
    VESICO-VAGINAL FISTULA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    FLASHES HOT
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    6 / 291 (2.06%)
         occurrences all number
    0
    7
    HOT FLUSHES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    8 / 300 (2.67%)
    11 / 291 (3.78%)
         occurrences all number
    11
    13
    HYPERTHYROIDISM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    ARTHRITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    3
    DISCOMFORT RIGHT ILIAC FOSSA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HNP
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    4
    INTERMITTENT LOW BACK PAIN
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    MUSLE WEAKNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    OSTEOARTHRITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SEROMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    STIFFNESS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    0 / 291 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    A COLD
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ABSCESS RIGHT SHOULDER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    BLADDER
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CANDIDIASIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    COLD SORE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    COLD/RHINITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    CYSTITIS INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    1 / 291 (0.34%)
         occurrences all number
    2
    1
    EPIDERMOLYSE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    2
    EPIDERMOLYSIS BUTTOCK
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    ERYSIPELAS R ARM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    FEBRILE NEUTROPENIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    8 / 300 (2.67%)
    2 / 291 (0.69%)
         occurrences all number
    9
    2
    HEPATITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HERPES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HERPETIC LIP
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INFECTED LYMPHOCELE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    44 / 300 (14.67%)
    32 / 291 (11.00%)
         occurrences all number
    50
    36
    INFECTION ANC
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INFECTION OF THE PICC
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    INFECTION PORT A CATH
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    ORAL HERPES
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PERINEAL FUNGALINFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    PICC CATHETER INFECTION R ARM
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    RENAL URINARY TRACT INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SALMONELLA AND CANDIDA INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SEPSIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    SKIN INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    2
    0
    STREPTOCOCCUS PNEUMONIA INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    TONSILLITIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    URINARY INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    2 / 300 (0.67%)
    2 / 291 (0.69%)
         occurrences all number
    2
    2
    URINARY TRACT INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    1 / 291 (0.34%)
         occurrences all number
    1
    2
    UROLOGIC INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    UROSEPSIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    VIRAL INFECTION
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    WOUND INFECTED
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    DECREASE CREATININE CLEARANCE
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HYPERGLYCEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HYPERKALEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    0 / 300 (0.00%)
    1 / 291 (0.34%)
         occurrences all number
    0
    1
    HYPOCALCEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    5 / 300 (1.67%)
    2 / 291 (0.69%)
         occurrences all number
    7
    4
    HYPO-KALEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    9 / 300 (3.00%)
    6 / 291 (2.06%)
         occurrences all number
    12
    10
    HYPOKALIEMA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    HYPO-MAGNESEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    11 / 300 (3.67%)
    2 / 291 (0.69%)
         occurrences all number
    22
    5
    HYPONATREMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    4 / 300 (1.33%)
    1 / 291 (0.34%)
         occurrences all number
    5
    1
    HYPOPHOSHATEMIA
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0
    LACTATE ACIDOSIS
    alternative dictionary used: CTC 2
         subjects affected / exposed
    1 / 300 (0.33%)
    0 / 291 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Sep 2003
    This amendment allowed incorporating tissue of the patients of the trial in the virtual tumor bank; adapting the document to reflect the EORTC policy for publication; and changing the requirement for the neo-adjuvant treatment arm. The minimum platinum dose was set at 225 mg/m² providing a minimum dose of platinum of 75 mg/m² per cycle irrespectively whether cycles are scheduled weekly or over 10 days, thus reflecting the daily practice of the majority of the centers.
    19 Feb 2014
    Following an EORTC Board meeting, a statistical analysis (to compare the two arms) was performed by an independent statistician according to EORTC procedures. It appears that there is a better survival, in contrast to what was expected in the protocol. Event rates for the primary endpoint are therefore lower than expected, negating any advantage of longer follow-up times currently achieved. Therefore, the recommendation of the independent statistician was to re-design the study. This major amendment included: - Change of primary end-point: from overall survival to overall survival at 5 years. - Secondary end-point: overall survival has been added - Total number of pts has been lowered from 686 to 625 - Eligibility criteria: addition of criteria about pregnancy test, contraception, breast feeding and hypersensitivity to component(s) of chemotherapeutics to be used or cisplatin contraindication. - Statistics chapters have been updated to reflect changes of end-points and number of patients. - The TR chapter has been completely revised to incorporate up-to-date rationale & proposals: genetic profile in cervical cancer; STAT(6)-expression for platinum-sensitivity in cervical cancer; influence of the tumor microenvironment on STAT phosphorylation; interaction between microenvironment, protein-expression and (epi)genetic alterations. - A standard chapter about HBM collection has been added. - The dummy run procedure for RTQA and PVU section have been updated - The PIS/IC has also been updated.

    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.
    The trial took almost 12 years (11 years + 8 months) to complete. The type of disease but also the difficulty of presenting patients with a randomized choice between surgery or radiotherapy played a role.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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