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    Clinical Trial Results:
    Gefitinib and methotrexate to resolve tubal ectopic pregnancy: the GEM3 RCT

    Summary
    EudraCT number
    		 2015-005013-76
    Trial protocol
    		 GB  
    Global end of trial date
    06 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Mar 2023
    First version publication date
    29 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AC15004
    Additional study identifiers
    ISRCTN number
    		 ISRCTN67795930
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Ethics number: 16/SS/0014
    Sponsors
    Sponsor organisation name
    University of Edinburgh and NHS Lothian
    Sponsor organisation address
    Queen's Medical Research Institute, 47 Little France Crescent Edinburgh, United Kingdom, EH16 4TJ
    Public contact
    Ann Doust, University of Edinburgh, 0044 1312422963, ann.doust@ed.ac.uk
    Scientific contact
    Ann Doust, University of Edinburgh, 0044 1312422963, ann.doust@ed.ac.uk
    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
    02 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a randomised controlled trial. To see if taking methotrexate (MTX) in combination with gefitinib is better at reducing the need for surgery against methotrexate alone in the treatment of stable tubal ectopic pregnancy.
    Protection of trial subjects
    Patient safety was monitored closely at each clinical care visit where adverse events were recorded.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2016
    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
    United Kingdom: 328
    Worldwide total number of subjects
    328
    EEA total number of subjects
    0
    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)
    328
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 GEM3 participants were recruited from early pregnancy units (EPU) in 50 of the 74 NHS participating sites across the UK. First participant was consented on 9th November 2016 and the last participant was consented on 6th October 2021.

    Pre-assignment
    Screening details
    		 Participants were screening clinically to ensure that they fulfilled the inclusion criteria

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Gefitinib
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gefitinib
    Investigational medicinal product code
    Other name
    Iressa
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250 mg for seven days

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet taken for 7 days

    Number of subjects in period 1
    		Active Placebo
    Started
    165
    163
    Completed
    165
    160
    Not completed
    0
    3
         Consent withdrawn by subject
    -
    1
         Pregnancy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 328 328
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 328 328
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 31.7 ( 5.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 328 328
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Gefitinib

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Surgical intervention

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    End point title
    		 Surgical intervention
    End point description
    End point type
    Primary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    165
    160
    Units: Number of women
        Yes
    50
    47
        No
    115
    113
    Statistical analysis title
    		 Full
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.58

    Secondary: Additional MTX

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    End point title
    		 Additional MTX
    End point description
    End point type
    Secondary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    165
    162
    Units: Number of women
        Yes
    20
    23
        No
    145
    139
    Statistical analysis title
    		 Additional MTX Analysis
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.28

    Secondary: Time to hCG Resolution

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    End point title
    		 Time to hCG Resolution
    End point description
    End point type
    Secondary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    165 [1]
    162 [2]
    Units: Days
        median (inter-quartile range (Q1-Q3))
    28.0 (23.5 to 36.0)
    28.0 (21.0 to 36.5)
    Notes
    [1] - Median presented for 108 women whose pregnancy resolved.
    [2] - Median presented in 108 women whose pregnancy resolved
    Statistical analysis title
    		 Time to hCG resolution-Cause specific hazard ratio
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.33
    Statistical analysis title
    		 Time to hCG resolution-Subdistribution hazard rati
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Fine and Grey competing risk model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.4

    Secondary: Number of hospital visits

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    End point title
    		 Number of hospital visits
    End point description
    End point type
    Secondary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    163
    162
    Units: Number of hospital visits
        median (inter-quartile range (Q1-Q3))
    5.0 (4.0 to 7.0)
    5.0 (3.0 to 6.0)
    Statistical analysis title
    		 Number of hospital visits analysis
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Incidence rate ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.12

    Secondary: Acceptability-satisfaction with treatment

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    End point title
    		 Acceptability-satisfaction with treatment
    End point description
    End point type
    Secondary
    End point timeframe
    3 months post pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    134
    138
    Units: Number of women
        Very satisfied
    59
    72
        Mostly satisfied
    44
    33
        Neither satisfied or dissatisfied
    24
    23
        Mostly dissatisfied
    3
    4
        Very dissatisfied
    4
    6
    Statistical analysis title
    		 Acceptability-Satisfaction with treatment analysis
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.12

    Secondary: Acceptability-acceptability of treatment

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    End point title
    		 Acceptability-acceptability of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    134
    138
    Units: Number of women
        Very acceptable
    78
    87
        Mostly acceptable
    32
    32
        Neither acceptable nor unacceptable
    19
    13
        Mostly unacceptable
    3
    4
        Very unacceptable
    2
    2
    Statistical analysis title
    		 Acceptability-acceptability of treatment analysis
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.28

    Secondary: Acceptability-recommend treatment

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    End point title
    		 Acceptability-recommend treatment
    End point description
    End point type
    Secondary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    134
    139
    Units: Number of women
        Very likely to recommend
    78
    93
        Fairly likely to recommend
    32
    33
        Neither likely to recommend or recommend against
    15
    4
        Fairly likely to recommend against
    4
    6
        Very likely to recommend against
    5
    3
    Statistical analysis title
    		 Acceptability-recommend treatment analysis
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Mixed models analysis
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.01

    Secondary: Return to menses

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    End point title
    		 Return to menses
    End point description
    End point type
    Secondary
    End point timeframe
    Up to pregnancy resolution (hCG <15 IU/L or surgical resolution).
    End point values
    		 Active Placebo
    Number of subjects analysed
    132
    134
    Units: days
        median (inter-quartile range (Q1-Q3))
    24.0 (24.0 to 38.0)
    24.0 (24.0 to 38.0)
    Statistical analysis title
    		 Return to menses analysis
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from time of consent to resolution of ectopic pregnancy (hCG <15 IU/L or surgical resolution).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.4
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 165 (3.03%)
    6 / 162 (3.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Scan
    Additional description: For renal calculi - none seen
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ultrasound scan
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Raised CRP
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laparoscopy
    Additional description: Ruptured ovarian cyst
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hyperventilation
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pelvic inflammatory disease
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 165 (22.42%)
    38 / 162 (23.46%)
    Vascular disorders
    Epistaxis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Laparoscopy
    Additional description: Only reported at the beginning of the trial. Protocol amended.
         subjects affected / exposed
    3 / 165 (1.82%)
    1 / 162 (0.62%)
         occurrences all number
    4
    4
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
    Additional description: Presenting with pain/rupture - reported in the beginning of the trial before a protocol amendment which meant this no longer had to be reported.
         subjects affected / exposed
    8 / 165 (4.85%)
    6 / 162 (3.70%)
         occurrences all number
    14
    14
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Immune system disorders
    Allergic reaction to excipient
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Pain
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Sore throat
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Hyperventilation
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Low mood
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 162 (0.62%)
         occurrences all number
    2
    2
    Investigations
    Low haemoglobin
         subjects affected / exposed
    2 / 165 (1.21%)
    2 / 162 (1.23%)
         occurrences all number
    4
    4
    Low lymphocytes
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    0
    Low white cell count
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Raised CRP
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Raised alanine aminotransferase level
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Low haematocrit
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 165 (3.03%)
    4 / 162 (2.47%)
         occurrences all number
    9
    9
    Feeling shaky
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Numbness
         subjects affected / exposed
    2 / 165 (1.21%)
    0 / 162 (0.00%)
         occurrences all number
    2
    2
    Paresthesia
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Deranged LFTs
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Reduced lymphocytes
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Reduced neutrophils
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Hearing loss
    Additional description: This was due to a cold
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Tinnitus
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Eye disorders
    Painful eyes
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Rectal pain
         subjects affected / exposed
    0 / 165 (0.00%)
    3 / 162 (1.85%)
         occurrences all number
    3
    3
    Bleeding gums
         subjects affected / exposed
    1 / 165 (0.61%)
    1 / 162 (0.62%)
         occurrences all number
    2
    2
    Toothache
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 162 (1.23%)
         occurrences all number
    2
    2
    Constipation
         subjects affected / exposed
    1 / 165 (0.61%)
    2 / 162 (1.23%)
         occurrences all number
    3
    3
    Rectal bleeding
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Tongue feeling burnt
    Additional description: Not due to eating or drinking. Happened spontaneously.
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 165 (2.42%)
    4 / 162 (2.47%)
         occurrences all number
    8
    8
    Dry skin
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    0
    Impetigo
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Nails breaking
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Candida infection
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Urinary urgency
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    3 / 165 (1.82%)
    4 / 162 (2.47%)
         occurrences all number
    7
    7
    Feeling weak
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 165 (0.61%)
    3 / 162 (1.85%)
         occurrences all number
    4
    4
    Chlamydial infection
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Insect bites
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Wound infection bacterial
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1
    COVID-19
         subjects affected / exposed
    2 / 165 (1.21%)
    0 / 162 (0.00%)
         occurrences all number
    2
    2
    Metabolism and nutrition disorders
    Loss of appetite
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 162 (0.62%)
         occurrences all number
    1
    1
    Raised potassium level
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 162 (0.00%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2016
    Protocol v4_Clarification of documents after ethical review
    10 Oct 2016
    Protocol v5_ clarificiation of terms following co-investigators, TSC and DMEC meetings
    12 Apr 2017
    Protocol v 6_clarification of processes, update of SmPC. Update to reflect TSC change of Chair and DMC change of statistician, contacts details of trial team.
    17 Apr 2017
    Protocol v7_Change to SmPC gefitinib. Change in contact details. Clarification of terms.
    26 Jul 2019
    Protocol v8_Change of address for Sharp Clinical UK. Removal of mechanistic study. Addition of information re long term follow up. Change of staff information. Addition of data management details.
    19 Feb 2021
    Protocol v9_Change to SmPC gefitinib and methotrexate. Minor changes to analysis section for clarification. Minor administrative changes for clarification of terms.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Mar 2020
    Recruitment stopped due to the COVID-19 pandemic.
    09 Jun 2021

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

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