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    Clinical Trial Results:
    A prospective randomised controlled trial comparing the use of open label pentoxifylline and tocopherol versus current standard of care for the prevention of fibrosis related outcomes in irradiated head and neck oncology patients (Feasibility Study)

    Summary
    EudraCT number
    		 2018-001153-27
    Trial protocol
    		 GB  
    Global end of trial date
    30 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2025
    First version publication date
    23 Aug 2025
    Other versions
    Summary report(s)
    		 PENVE CSR EudraCT Results Upload 13Jun25

    Trial information

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    Trial identification
    Sponsor protocol code
    PenVe
    Additional study identifiers
    ISRCTN number
    		 ISRCTN74484952
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE1 9RT
    Public contact
    Mr Vinod Patel, , Guy's and St Thomas' NHS Foundation Trust, 44 0207188 3885, vinod.patel@gstt.nhs.uk
    Scientific contact
    Mr Vinod Patel, , Guy's and St Thomas' NHS Foundation Trust, 44 0207188 3885, vinod.patel@gstt.nhs.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
    28 Nov 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the feasibility of a randomised controlled trial of pentoxifylline in combination with vitamin E (PVe) for the prevention of radiation induced fibrosis outcomes in head and neck radiotherapy patients compared to best standard of care. •To assess patient’s preference for pentoxifylline and vitamin E formulation, in a tablet vs liquid format (Intervention group only) •To assess patient’s subsequent side effects related to the pentoxifylline and vitamin E (Intervention group only) • To assess the recruitment into the trial • To assess retention of the participants in the trial • To assess the participation in the trial follow up visits and phone calls • To assess patient adherence to pentoxifylline and Vitamin E (Intervention group only) • To assess the acceptability to participants of the outcome measurement tools
    Protection of trial subjects
    Participants have the right to withdraw from the study at any time for any reason. The investigator also has the right to withdraw patients from the study drug in the event of inter-current illness, AEs, SAE’s, SUSAR’s, protocol violations, cure, administrative reasons or other reasons. Participants who develop ORN will be withdrawn from the study. Reaching this endpoint would mean that the treatment did not work and would be of no benefit to continue. Outcome measures would also not be comparable to participants who did not develop ORN. It is understood by all concerned that an excessive rate of withdrawals can render the study un-interpretable; therefore, unnecessary withdrawal of patients should be avoided. Should a patient decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible. Should a patient withdraw from study drug only, efforts will be made to continue to retain and obtain follow-up data, with the permission of the patient. Participants who wish to withdraw from trial medication (IMP) will be asked to confirm whether they are still willing to provide the following: · Trial specific data at visits attended · Data collected as per routine clinical practice at visits attended
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    22
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 54 [1]
    Number of subjects completed
    		 29

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen Failure: 25
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: We do not count screening participants as enrolled
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    open labelled trial investigating outcomes following the prophylactic use of pentoxifylline and tocopherol in irradiated head and neck oncology patients.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Investigational Arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pentoxifylline & Tocopheryl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Modified-release tablet, Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    -Pentoxifylline dose: 400mg (liquid or tablet formulation) TWICE a day. -Vitamin E (alpha-tocopheryl) dose: 1000 IU (liquid or tablet formulation) ONCE a day.

    Arm title
    		 Control
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Investigational Arm Control
    Started
    22
    7
    Completed
    16
    6
    Not completed
    6
    1
         Treatment failure
    1
    -
         Lost to follow-up
    3
    -
         No longer wished to take part
    1
    1
         Had recurrence of cancer
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Investigational Arm
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group values
    		 Investigational Arm Control Total
    Number of subjects
    		 22 7 29
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.3 ( 8.60 ) 56.9 ( 6.64 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 1 5
        Male
    		 18 6 24

    End points

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    End points reporting groups
    Reporting group title
    Investigational Arm
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Primary: Primary outcome 1: Requested formulation change for Pentoxifylline or Vitamin E

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    End point title
    		 Primary outcome 1: Requested formulation change for Pentoxifylline or Vitamin E [1]
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 to Month 6
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Investigational Arm Control
    Number of subjects analysed
    22
    7
    Units: 29
        Yes
    0
    0
        No, never requested to change formulation during
    22
    0
        No, participant is not in intervention arm
    0
    5
        Not applicable
    0
    2
        Missing
    0
    0
    No statistical analyses for this end point

    Primary: Primary Outcome 5a: Participation in the trial follow-up visits (Intent-to-treat population)

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    End point title
    		 Primary Outcome 5a: Participation in the trial follow-up visits (Intent-to-treat population) [2]
    End point description
    Participation in the trial follow-up visits (Intent-to-treat population)
    End point type
    Primary
    End point timeframe
    Baseline to Month 6
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Investigational Arm Control
    Number of subjects analysed
    22
    7
    Units: 29
        Visit 1 (Absent)
    0
    0
        Visit 1 (Present)
    22
    7
        Visit 2 (Absent)
    0
    0
        Visit 2 (Present)
    22
    7
        Visit 3 (Absent)
    0
    0
        Visit 3 (Present)
    22
    7
        Visit 4 (Absent)
    1
    1
        Visit 4 (Present)
    21
    6
        Visit 5 (Absent)
    3
    1
        Visit 5 (Present)
    19
    6
        Visit 6 (Absent)
    0
    0
        Visit 6 (Present)
    22
    7
    No statistical analyses for this end point

    Primary: Primary Outcome 5b: Participation in trial follow-up visits (Intent-to-treat population) - phone call

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    End point title
    		 Primary Outcome 5b: Participation in trial follow-up visits (Intent-to-treat population) - phone call [3] [4]
    End point description
    Participation in trial follow-up visits by phone call (Intent-to-treat population)
    End point type
    Primary
    End point timeframe
    Baseline to Month 6
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only concerned the active intervention arm. Please see uploaded report
    End point values
    		 Investigational Arm
    Number of subjects analysed
    22
    Units: 22
        Day 1 Team contacted participant - Successful
    19
        Day 1 Team contacted participant - Not Successful
    0
        Day 1 Participant contacted study team
    0
        Day 1 Not applicable
    0
        Day 1 Missing
    3
        Day 2 Team contacted participant - Successful
    18
        Day 2 Team contacted participant - Not Successful
    1
        Day 2 Participant contacted study team
    0
        Day 2 Not applicable
    0
        Day 2 Missing
    3
        Day 3 Team contacted participant - Successful
    19
        Day 3 Team contacted participant - Not Successful
    0
        Day 3 Participant contacted study team
    0
        Day 3 Not applicable
    0
        Day 3 Missing
    3
        Day 4 Team contacted participant - Successful
    19
        Day 4 Team contacted participant - Not Successful
    0
        Day 4 Participant contacted study team
    0
        Day 4 Not applicable
    0
        Day 4 Missing
    3
        Day 5 Team contacted participant - Successful
    19
        Day 5 Team contacted participant - Not Successful
    0
        Day 5 Participant contacted study team
    0
        Day 5 Not applicable
    0
        Day 5 Missing
    3
        Day 6 Team contacted participant - Successful
    17
        Day 6 Team contacted participant - Not Successful
    2
        Day 6 Participant contacted study team
    0
        Day 6 Not applicable
    0
        Day 6 Missing
    3
        Day 7 Team contacted participant - Successful
    19
        Day 7 Team contacted participant - Not Successful
    0
        Day 7 Participant contacted study team
    0
        Day 7 Not applicable
    0
        Day 7 Missing
    3
        Day 8 Team contacted participant - Successful
    18
        Day 8 Team contacted participant - Not Successful
    1
        Day 8 Participant contacted study team
    0
        Day 8 Not applicable
    0
        Day 8 Missing
    3
        Day 9 Team contacted participant - Successful
    17
        Day 9 Team contacted participant - Not Successful
    2
        Day 9 Participant contacted study team
    0
        Day 9 Not applicable
    0
        Day 9 Missing
    3
        Day 10 Team contacted participant - Successful
    19
        Day 10 Team contacted participant - Not Successful
    0
        Day 10 Participant contacted study team
    0
        Day 10 Not applicable
    0
        Day 10 Missing
    3
        Day 11 Team contacted participant - Successful
    17
        Day 11 Team contacted participant - Not Successful
    1
        Day 11 Participant contacted study team
    0
        Day 11 Not applicable
    0
        Day 11 Missing
    4
        Day 12 Team contacted participant - Successful
    16
        Day 12 Team contacted participant - Not Successful
    2
        Day 12 Participant contacted study team
    0
        Day 12 Not applicable
    0
        Day 12 Missing
    4
        Day 13 Team contacted participant - Successful
    17
        Day 13 Team contacted participant - Not Successful
    1
        Day 13 Participant contacted study team
    0
        Day 13 Not applicable
    0
        Day 13 Missing
    4
        Day 14 Team contacted participant - Successful
    17
        Day 14 Team contacted participant - Not Successful
    1
        Day 14 Participant contacted study team
    0
        Day 14 Not applicable
    0
        Day 14 Missing
    4
        Week 5 Team contacted participant - Successful
    15
        Week 5 Team contacted participant - Not Successful
    3
        Week 5 Participant contacted study team
    0
        Week 5 Not applicable
    0
        Week 5 Missing
    4
        Week 8 Team contacted participant - Successful
    14
        Week 8 Team contacted participant - Not Successful
    2
        Week 8 Participant contacted study team
    0
        Week 8 Not applicable
    0
        Week 8 Missing
    6
        Week 11 Team contacted participant Successful
    14
        Week 11 Team contacted participant Not Successful
    2
        Week 11 Participant contacted study team
    0
        Week 11 Not applicable
    0
        Week 11 Missing
    6
        Week 14 Team contacted participant Successful
    11
        Week 14 Team contacted participant Not Successful
    5
        Week 14 Participant contacted study team
    0
        Week 14 Not applicable
    0
        Week 14 Missing
    6
        Week 17 Team contacted participant Successful
    10
        Week 17 Team contacted participant Not Successful
    3
        Week 17 Participant contacted study team
    0
        Week 17 Not applicable
    0
        Week 17 Missing
    9
        Week 20 Team contacted participant Successful
    10
        Week 20 Team contacted participant Not Successful
    3
        Week 20 Participant contacted study team
    0
        Week 20 Not applicable
    0
        Week 20 Missing
    9
        Week 23 Team contacted participant Successful
    9
        Week 23 Team contacted participant Not Successful
    2
        Week 23 Participant contacted study team
    0
        Week 23 Not applicable
    0
        Week 23 Missing
    11
        Week 26 Team contacted participant Successful
    5
        Week 26 Team contacted participant Not Successful
    2
        Week 26 Participant contacted study team
    0
        Week 26 Not applicable
    0
        Week 26 Missing
    15
    No statistical analyses for this end point

    Primary: Primary Outcome 6: Patient adherence as measured by blood vitamin E levels at Baseline, Month 3 and Month 6 time points (Intent-to-Treat Population)

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    End point title
    		 Primary Outcome 6: Patient adherence as measured by blood vitamin E levels at Baseline, Month 3 and Month 6 time points (Intent-to-Treat Population) [5]
    End point description
    Patient adherence as measured by blood vitamin E levels at Baseline, Month 3 and Month 6 time points (Intent-to-Treat Population
    End point type
    Primary
    End point timeframe
    Day 1 to Month 6
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Investigational Arm Control
    Number of subjects analysed
    22
    7
    Units: ng/mL
    arithmetic mean (standard deviation)
        Baseline
    35.2 ( 10.6 )
    29.6 ( 7.34 )
        Month 3
    91.8 ( 184 )
    31.8 ( 5.36 )
        Month 6
    55.2 ( 22.3 )
    31.6 ( 8.41 )
    No statistical analyses for this end point

    Primary: Primary outcome 6: Patient adherence to IMP measured by self-report (only intervention arm of Intent-to-Treat Population)

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    End point title
    		 Primary outcome 6: Patient adherence to IMP measured by self-report (only intervention arm of Intent-to-Treat Population) [6] [7]
    End point description
    Patient adherence to IMP measured by self-report (only intervention arm of Intent-to-Treat Population)
    End point type
    Primary
    End point timeframe
    Day 1 to Month 6
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only concerned the active intervention arm. Please see uploaded report
    End point values
    		 Investigational Arm
    Number of subjects analysed
    22
    Units: 100
        Number of missed Vitamin E doses (%)
    10
        Number of missed Pentoxifylline doses (%)
    25
    No statistical analyses for this end point

    Primary: Primary Outcome 7: Acceptability of questionnaires as measures by the number (%) of Questionnaires Completed by Participants by Treatment (Intent-to-Treat Population)

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    End point title
    		 Primary Outcome 7: Acceptability of questionnaires as measures by the number (%) of Questionnaires Completed by Participants by Treatment (Intent-to-Treat Population) [8]
    End point description
    Acceptability of questionnaires as measures by the number (%) of Questionnaires Completed by Participants by Treatment (Intent-to-Treat Population)
    End point type
    Primary
    End point timeframe
    Baseline to month 6
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see uploaded report
    End point values
    		 Investigational Arm Control
    Number of subjects analysed
    22
    7
    Units: 29
        Baseline (UW-QOL) Complete
    18
    5
        Baseline (UW-QOL) Incomplete
    4
    2
        Month 3 (UW-QOL) Complete
    16
    5
        Month 3 (UW-QOL) Incomplete
    6
    2
        Month 6 (UW-QOL) Complete
    12
    5
        Month 6 (UW-QOL) Incomplete
    10
    2
        Baseline (SSQ) Complete
    20
    7
        Baseline (SSQ) Incomplete
    2
    0
        Month 3 (SSQ) Complete
    13
    6
        Month 3 (SSQ) Incomplete
    9
    1
        Month 6 (SSQ) Complete
    8
    6
        Month 6 (SSQ) Incomplete
    14
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to month 6 visit
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Pentoxifylline & Vitamin E
    Reporting group description
    		 -

    Reporting group title
    Contol
    Reporting group description
    		 -

    Serious adverse events
    		 Pentoxifylline & Vitamin E Contol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    High Temperature
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (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
    		 Pentoxifylline & Vitamin E Contol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 22 (50.00%)
    1 / 7 (14.29%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Recurrent head and neck cancer
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Surgical and medical procedures
    Radiography to replace NG tube
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Muscle Pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 7 (0.00%)
         occurrences all number
    6
    0
    Dry mouth
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 7 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Saliva decreased
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    1
    NG tube fell out
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Purulent phlegm
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Pain in jaw
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Tongue pain
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 7 (0.00%)
         occurrences all number
    6
    0
    Migraine
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia (leg)
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Gastric Irritation
         subjects affected / exposed
    3 / 22 (13.64%)
    0 / 7 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    10
    0
    Constipation
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    2 / 22 (9.09%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Oesophagitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Abdominal noises
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Throat irritation
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    COVID
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Dry throat
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 22 (4.55%)
    0 / 7 (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
    10 Jun 2020
    SA protocol V2
    01 Apr 2021
    IMPD v4.0

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    COVID
    05 Oct 2020

    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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