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    Clinical Trial Results:
    PARAGON: Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms

    Summary
    EudraCT number
    		 2011-000501-52
    Trial protocol
    		 GB  
    Global end of trial date
    30 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2021
    First version publication date
    20 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    PARAGON2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Australian New Zealand Clinical Trials Registry: ACTRN12610000796088
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow & Clyde and University of Glasgow
    Sponsor organisation address
    NHS Greater Glasgow & Clyde Research & Innovation, Ward 11, Dykebar hospital, Grahamston Road, Paisley, United Kingdom, PA2 7DE
    Public contact
    Laura Alexander, Project Manager, Cancer Research UK Clinical Trials Unit, +44 01413017212, laura.alexander@glasgow.ac.uk
    Scientific contact
    Laura Alexander, Project Manager, Cancer Research UK Clinical Trials Unit, +44 01413017212, laura.alexander@glasgow.ac.uk
    Sponsor organisation name
    University of Sydney
    Sponsor organisation address
    Locked Bag 77, Camperdown, Australia, 2050
    Public contact
    Nathan Bradshaw, University of Sydney, 61 295625000, paragon@ctc.usyd.edu.au
    Scientific contact
    Nathan Bradshaw, University of Sydney, 61 295625000, paragon@ctc.usyd.edu.au
    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
    11 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal objective of the study is clinical benefit rate determined by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment.
    Protection of trial subjects
    As the study drug (anastrozole) lowers circulating oestrogen levels it may cause a reduction in bone mineral density (thinning of the bones) which in some people may put them at an increased risk of broken bones (fractures). Women who have or are at risk of severe bone thinning (osteoporosis) may have their bone mineral density formally assessed by a special type of scan called bone densitometry (DEXA) before they start treatment and at 1-2 year intervals depending on the findings. For this reason it is recommended, that a DEXA scan of hip, femoral neck or lumbar spine be performed within 12 months of registration to this trial for each patient and the need for a scan will be decided by your treating doctor. Anastrozole is not recommended for use in premenopausal women as safety and efficacy have not been established. Women with child bearing potential will not be included in this trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2011
    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
    Australia: 206
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    United Kingdom: 96
    Country: Number of subjects enrolled
    Belgium: 17
    Worldwide total number of subjects
    331
    EEA total number of subjects
    17
    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)
    167
    From 65 to 84 years
    164
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Women with oestrogen receptor and/or progesterone receptor positive (ER/PR+ve) potentially hormone responsive recurrent or metastatic gynaecological cancers including selected patients with epithelial ovarian cancer, endometrial cancers, miscellaneous sarcomas and sex cord stromal tumours of the ovary

    Pre-assignment
    Screening details
    		 Patients with recurrent or metastatic gynaecological cancer with previous primary tumour diagnosis confirmed histologically. All patients will have central review and analyses of ER/PR at a later date to confirm receptor status, but entry to the study will be based on hormone receptor positivity according to local hormone receptor analyses.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 Single Arm study
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anastrozole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tabley (1mg) taken orally once a day

    Number of subjects in period 1
    		Single Arm
    Started
    331
    Treatment
    331
    Completed
    331

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 Single Arm study

    Reporting group values
    		 Single Arm Total
    Number of subjects
    		 331 331
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 167 167
        From 65-84 years
    		 160 160
        85 years and over
    		 4 4
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.79 ( 11.17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 331 331
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Endometrial Stroma Sarcoma
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with low-grade endometrial stromal sarcomas

    Subject analysis set title
    PRROC
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Estrogen or Progesterone Receptor- Positive Platinum-Resistant or -Refractory Recurrent Ovarian Cancer

    Subject analysis set title
    CA125
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Asymptomatic patients with estrogen and progesterone receptor-positive recurrent ovarian cancer and CA125 progression

    Subject analysis set title
    Endometrial Cancer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer

    Subject analysis set title
    Low Grade Ovarian
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with estrogen receptor-positive recurrent/metastatic low-grade ovarian cancers and serous borderline ovarian tumors

    Subject analysis set title
    Granulosa Cell Tumour
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with metastatic granulosa cell tumours

    Subject analysis set title
    Metastatic Leiomyosarcoma
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with recurrent/metastatic leimoyosarcoma

    Subject analysis set title
    Uterine Carcinosarcoma
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with recurrent/metastatic uterine carcinosarcoma(UCS)

    Subject analysis sets values
    		 Endometrial Stroma Sarcoma PRROC CA125 Endometrial Cancer Low Grade Ovarian Granulosa Cell Tumour Metastatic Leiomyosarcoma Uterine Carcinosarcoma
    Number of subjects
    15
    49
    52
    82
    36
    39
    32
    7
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    12
    25
    35
    27
    23
    28
        From 65-84 years
    9
    28
    21
    57
    14
    12
        85 years and over
    0
    0
    0
    3
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    61.63 ( 9.92 )
    65.08 ( 9.43 )
    65.40 ( 10.36 )
    68.23 ( 8.79 )
    57.19 ( 16.09 )
    59.60 ( 9.65 )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    15
    49
    52
    82
    36
    39
        Male
    0
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 Single Arm study

    Subject analysis set title
    Endometrial Stroma Sarcoma
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with low-grade endometrial stromal sarcomas

    Subject analysis set title
    PRROC
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with Estrogen or Progesterone Receptor- Positive Platinum-Resistant or -Refractory Recurrent Ovarian Cancer

    Subject analysis set title
    CA125
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Asymptomatic patients with estrogen and progesterone receptor-positive recurrent ovarian cancer and CA125 progression

    Subject analysis set title
    Endometrial Cancer
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with recurrent estrogen (ER)/progesterone (PR) positive endometrial cancer

    Subject analysis set title
    Low Grade Ovarian
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with estrogen receptor-positive recurrent/metastatic low-grade ovarian cancers and serous borderline ovarian tumors

    Subject analysis set title
    Granulosa Cell Tumour
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with metastatic granulosa cell tumours

    Subject analysis set title
    Metastatic Leiomyosarcoma
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with recurrent/metastatic leimoyosarcoma

    Subject analysis set title
    Uterine Carcinosarcoma
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients with recurrent/metastatic uterine carcinosarcoma(UCS)

    Primary: Clinical Benefit Rate (Proportion of patients with Stable Disease or Response)

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    End point title
    		 Clinical Benefit Rate (Proportion of patients with Stable Disease or Response)
    End point description
    Clinical benefit rate as determined by the proportion of patients experiencing either stable disease or response within 3 months of commencing treatment.
    End point type
    Primary
    End point timeframe
    Within 3 months of commencing treatment
    End point values
    		 Endometrial Stroma Sarcoma PRROC CA125 Endometrial Cancer Low Grade Ovarian Granulosa Cell Tumour Metastatic Leiomyosarcoma Uterine Carcinosarcoma
    Number of subjects analysed
    15
    49
    52
    82
    36
    39
    32
    7
    Units: Number of patients
    11
    13
    18
    36
    23
    32
    11
    3
    Statistical analysis title
    		 Kaplan-Meier
    Statistical analysis description
    Analysis was performed using the proportion of patients who responded/experienced clinical benefit together with 95% confidence interval for the estimates. Comparisons were two-tailed and a nominal significance level of 0.05 was applied. nalysed using tusing time-to-event methods, with Kaplan-Meier survival curves constructed for graphical display and unadjusted log-rank tests performed where appropriate. 95% CIs for proportions were constructed using the Wilson method
    Comparison groups
    PRROC v CA125
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Single arm, phase 2,

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Progression free survival
    End point values
    		 Endometrial Stroma Sarcoma PRROC CA125 Endometrial Cancer Low Grade Ovarian Granulosa Cell Tumour Metastatic Leiomyosarcoma Uterine Carcinosarcoma
    Number of subjects analysed
    0 [2]
    49
    52
    82
    36
    39
    32
    7
    Units: Average months of PFS
        median (confidence interval 95%)
    ( to )
    2.7 (2.0 to 2.8)
    2.7 (2.1 to 3.1)
    3.2 (2.8 to 5.4)
    11.1 (3.2 to 11.9)
    8.6 (5.5 to 13.5)
    2.8 (2.6 to 4.9)
    2.7 (1.1 to 8.2)
    Notes
    [2] - Median PFS was not reached
    Statistical analysis title
    		 Kaplan-Meier
    Statistical analysis description
    Time-to-event analyses will be described with Kaplan-Meier curves and, where appropriate unadjusted logrank tests will be performed. Death from any cause will be considered as an event.
    Comparison groups
    Endometrial Cancer v CA125
    Number of subjects included in analysis
    134
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [3] - Single arm, phase 2 trial

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of response in each subgroup
    End point values
    		 Endometrial Stroma Sarcoma PRROC CA125 Endometrial Cancer Low Grade Ovarian Granulosa Cell Tumour Metastatic Leiomyosarcoma Uterine Carcinosarcoma
    Number of subjects analysed
    0 [4]
    49
    52
    82
    36
    39
    Units: Average number of months
        median (confidence interval 95%)
    ( to )
    2.8 (2.6 to 5.7)
    6.5 (2.8 to 11.7)
    5.6 (3.0 to 13.7)
    9.5 (8.3 to 25.8)
    8.4 (4.3 to 14.8)
    5.8 (2.2 to 58.3)
    5.6 (2.5 to 5.7)
    Notes
    [4] - only 1 patient progressed (at 13 months after achieving benefit) so a median could not be estimated.
    Statistical analysis title
    		 Kaplan-Meier
    Statistical analysis description
    duration of clinical benefit were analysed using time-to-event methods, with Kaplan-Meier survival curves constructed for graphical display and unadjusted log-rank tests performed where appropriate. Death from any cause was considered an event.
    Comparison groups
    PRROC v CA125 v Endometrial Cancer v Low Grade Ovarian
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline SAEs are reported up to 30 days from the end of study drug administration.
    Adverse event reporting additional description
    Once a month for the first 3 months, 3-monthly until progression.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 Single Arm study

    Serious adverse events
    		 Single Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    67 / 331 (20.24%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Gastric Outlet Obstruction
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest Pain
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Abdominal Pain
         subjects affected / exposed
    8 / 331 (2.42%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Thromboembolic Event
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Vaginal Haemorrhage
         subjects affected / exposed
    4 / 331 (1.21%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bowel obstruction
         subjects affected / exposed
    6 / 331 (1.81%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    3 / 331 (0.91%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chest Infection
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Urinary Incontinence
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 331 (1.51%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Creatine urine increased
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic pain
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Constipation
         subjects affected / exposed
    4 / 331 (1.21%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 331 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 331 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Single Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    286 / 331 (86.40%)
    Vascular disorders
    Raynaud's phenomenon
         subjects affected / exposed
    12 / 331 (3.63%)
         occurrences all number
    25
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    68 / 331 (20.54%)
         occurrences all number
    158
    Fatigue
         subjects affected / exposed
    200 / 331 (60.42%)
         occurrences all number
    635
    Alopecia
         subjects affected / exposed
    33 / 331 (9.97%)
         occurrences all number
    64
    Pain
         subjects affected / exposed
    21 / 331 (6.34%)
         occurrences all number
    34
    Abdominal pain
         subjects affected / exposed
    96 / 331 (29.00%)
         occurrences all number
    160
    Back pain
         subjects affected / exposed
    22 / 331 (6.65%)
         occurrences all number
    48
    Immune system disorders
    Raynaud's phenomenon
         subjects affected / exposed
    11 / 331 (3.32%)
         occurrences all number
    25
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    13 / 331 (3.93%)
         occurrences all number
    27
    Vaginal dryness
         subjects affected / exposed
    48 / 331 (14.50%)
         occurrences all number
    162
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    24 / 331 (7.25%)
         occurrences all number
    38
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    9 / 331 (2.72%)
         occurrences all number
    23
    Insomnia
         subjects affected / exposed
    32 / 331 (9.67%)
         occurrences all number
    54
    Depression
         subjects affected / exposed
    6 / 331 (1.81%)
         occurrences all number
    15
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    16 / 331 (4.83%)
         occurrences all number
    33
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    8 / 331 (2.42%)
         occurrences all number
    26
    Myalgia
         subjects affected / exposed
    11 / 331 (3.32%)
         occurrences all number
    20
    Peripheral sensory neuropathy
         subjects affected / exposed
    36 / 331 (10.88%)
         occurrences all number
    80
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    12 / 331 (3.63%)
         occurrences all number
    16
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    21 / 331 (6.34%)
         occurrences all number
    21
    Abdominal pain
         subjects affected / exposed
    131 / 331 (39.58%)
         occurrences all number
    85
    Reflux gastritis
         subjects affected / exposed
    12 / 331 (3.63%)
         occurrences all number
    25
    Vomiting
         subjects affected / exposed
    49 / 331 (14.80%)
         occurrences all number
    61
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    9 / 331 (2.72%)
         occurrences all number
    22
    Hot flush
    Additional description: AKA Hot Flashes
         subjects affected / exposed
    22 / 331 (6.65%)
         occurrences all number
    25
    Rash
         subjects affected / exposed
    41 / 331 (12.39%)
         occurrences all number
    63
    Renal and urinary disorders
    Urinary incontinence
         subjects affected / exposed
    13 / 331 (3.93%)
         occurrences all number
    19
    Endocrine disorders
    Abnormal Lipids
         subjects affected / exposed
    27 / 331 (8.16%)
         occurrences all number
    55
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    4 / 331 (1.21%)
         occurrences all number
    15
    Neuropathy peripheral
         subjects affected / exposed
    53 / 331 (16.01%)
         occurrences all number
    81
    Dyspnoea
         subjects affected / exposed
    16 / 331 (4.83%)
         occurrences all number
    33
    Arthralgia
         subjects affected / exposed
    171 / 331 (51.66%)
         occurrences all number
    506
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    69 / 331 (20.85%)
         occurrences all number
    112
    Nausea
         subjects affected / exposed
    107 / 331 (32.33%)
         occurrences all number
    193
    Constipation
         subjects affected / exposed
    67 / 331 (20.24%)
         occurrences all number
    124

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jul 2012
    inclusion of the Granulosa Cell Subgroup Study which requires the collection of blood from patients should they consent to participateI

    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.
    N/A

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31130288
    http://www.ncbi.nlm.nih.gov/pubmed/31227223
    http://www.ncbi.nlm.nih.gov/pubmed/31328463
    http://www.ncbi.nlm.nih.gov/pubmed/28498256
    http://www.ncbi.nlm.nih.gov/pubmed/33608144
    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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