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    Clinical Trial Results:
    Evaluation of the safety of CEdiranib in the prevention of Bowel perforation in platinum-resistant Ovarian Cancer

    Summary
    EudraCT number
    		 2016-004618-93
    Trial protocol
    		 GB  
    Global end of trial date
    23 Jul 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Mar 2025
    First version publication date
    20 Mar 2025
    Other versions
    Summary report(s)
    		 CEBOC

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    R120502
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 U1111-1200-5948
    Sponsors
    Sponsor organisation name
    University of Manchester
    Sponsor organisation address
    Oxford Road, Manchester, United Kingdom, M13 9PL
    Public contact
    CEBOC Trial Manager, Cancer Division Centre for Trials Research Cardiff, +44 02920687465, CEBOC@cardiff.ac.uk
    Scientific contact
    CEBOC Trial Manager, Cancer Division Centre for Trials Research Cardiff, +44 02920687465, CEBOC@cardiff.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
    23 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The trial is trying to find out if it is safe to treat women who have advanced ovarian cancer and are at risk of developing malignant bowel obstruction (bowel blockage due to advanced cancer) with a weekly dose of standard chemotherapy (paclitaxel) plus a new oral tablet medication (cediranib).
    Protection of trial subjects
    The trial would stop if: • More than 1 patient experienced an event (bowel perforation/ fistula) in stage 1 OR: • Three (03) or more participants experienced an event at any point in the trial The trial may also be terminated for other safety reasons if recommended by the IDMC and agreed by the TSC.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable (single-arm)
    Actual start date of recruitment
    27 Nov 2017
    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: 30
    Worldwide total number of subjects
    30
    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)
    17
    From 65 to 84 years
    12
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited started March 2018 and ended February 2021

    Pre-assignment
    Screening details
    		 Prior to paclitaxel/nab-paclitaxel and cediranib: Histologically confirmed, progressive, platinum-resistant or refractory, high-grade ovarian, fallopian tube or primary peritoneal cancer for which weekly paclitaxel or nab-paclitaxel would be a potential treatment option. Prior to cediranib and olaparib Radiological evidence of PD

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Paclitaxel +/- cediranib
    Arm description
    		 This is a single arm, phase II trial of cediranib 20mg/day with weekly paclitaxel 70mg/m2/week in patients with recurrent platinum-resistant ovarian cancer and clinical and/or radiological features indicating an increased risk of developing subacute bowel obstruction. At the point of developing progressive disease (PD), participants cease paclitaxel and have the option of continuing cediranib 20mg/day with olaparib 300mg bd twice daily continuously until further PD occurs.
    Arm type
    		 Single arm

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Paclitaxel will be administered at a dose of 70mg/m2 on days 1, 8 and 15 of a 21-day cycle for a maximum of 6 cycles.

    Investigational medicinal product name
    Cediranib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg daily. Maintenance cediranib will start up to 9 weeks after cycle 1 day 1 of weekly paclitaxel. Cediranib can be initiated when bowel symptoms have abated to grade 1 or less or the risk to the patient’s bowel has been minimised. Participants will be given one bottle containing 35 tablets. Further cediranib may be dispensed mid-cycle if necessary, to manage dose reductions. Within each bottle all tablets will be the same strength (either 20 mg or 15 mg).

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The olaparib trial treatment will be dispensed to patients for a dose of 300 mg twice daily equivalent to a total daily dose of 600 mg which is equivalent to the 400 mg capsules twice daily dose16. The 100 mg and 150 mg tablets will be used to manage dose reductions. On the first day of each 21-day cycle, participants will be given three bottles each containing 32 tablets. Further olaparib may be dispensed mid-cycle if necessary, to manage dose reductions. Within each bottle all tablets will be the same strength (either 100 mg or 150 mg).

    Number of subjects in period 1
    		Paclitaxel +/- cediranib
    Started
    30
    Completed
    30
    Period 2
    Period 2 title
    Cediranib treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Paclitaxel +/- cediranib
    Arm description
    		 This is a single arm, phase II trial of cediranib 20mg/day with weekly paclitaxel 70mg/m2/week in patients with recurrent platinum-resistant ovarian cancer and clinical and/or radiological features indicating an increased risk of developing subacute bowel obstruction. At the point of developing progressive disease (PD), participants cease paclitaxel and have the option of continuing cediranib 20mg/day with olaparib 300mg bd twice daily continuously until further PD occurs.
    Arm type
    		 Single arm

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Paclitaxel will be administered at a dose of 70mg/m2 on days 1, 8 and 15 of a 21-day cycle for a maximum of 6 cycles.

    Investigational medicinal product name
    Cediranib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg daily. Maintenance cediranib will start up to 9 weeks after cycle 1 day 1 of weekly paclitaxel. Cediranib can be initiated when bowel symptoms have abated to grade 1 or less or the risk to the patient’s bowel has been minimised. Participants will be given one bottle containing 35 tablets. Further cediranib may be dispensed mid-cycle if necessary, to manage dose reductions. Within each bottle all tablets will be the same strength (either 20 mg or 15 mg).

    Investigational medicinal product name
    Olaparib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The olaparib trial treatment will be dispensed to patients for a dose of 300 mg twice daily equivalent to a total daily dose of 600 mg which is equivalent to the 400 mg capsules twice daily dose16. The 100 mg and 150 mg tablets will be used to manage dose reductions. On the first day of each 21-day cycle, participants will be given three bottles each containing 32 tablets. Further olaparib may be dispensed mid-cycle if necessary, to manage dose reductions. Within each bottle all tablets will be the same strength (either 100 mg or 150 mg).

    Number of subjects in period 2
    		Paclitaxel +/- cediranib
    Started
    30
    Completed
    30

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 30 30
    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)
    		 17 17
        From 65-84 years
    		 12 12
        85 years and over
    		 1 1
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 0 0
        Missing
    		 0 0
    Histopathological diagnosis
    Units: Subjects
        Ovarian
    		 21 21
        Primary peritoneal
    		 3 3
        Fallopian tube
    		 5 5
        Ovarian and primary peritoneal
    		 1 1
    Histological ovarian subtype
    Units: Subjects
        High grade serous
    		 28 28
        Carcinosarcoma
    		 1 1
        High grade serous and carcinosarcoma
    		 1 1
    FIGO stage at diagnosis
    Units: Subjects
        Stage 1A
    		 1 1
        Stage 1 C2
    		 1 1
        Stage 2A
    		 1 1
        Stage 2B
    		 1 1
        Stage 3B
    		 3 3
        Stage 3C
    		 17 17
        Stage 4A
    		 2 2
        Stage 4B
    		 4 4
    Symptoms of bowel obstruction risk
    Units: Subjects
        Yes
    		 29 29
        No
    		 1 1
    Prior first-line platinum based chemotherapy
    Units: Subjects
        Yes
    		 30 30
        No
    		 0 0
    Received prior radiotherapy
    Units: Subjects
        Yes
    		 1 1
        No
    		 29 29
    Prior surgery
    Units: Subjects
        Yes
    		 28 28
        No
    		 2 2
    Residual disease left
    Units: Subjects
        >10mm
    		 10 10
        <10mm
    		 18 18
        Missing
    		 2 2
    Received anti-cancer treatment in first line setting
    Units: Subjects
        Yes
    		 30 30
        No
    		 0 0
    If yes, number of lines
    Units: Subjects
        One
    		 5 5
        Two
    		 6 6
        Three
    		 8 8
        Four
    		 7 7
        Five
    		 2 2
        Six
    		 2 2
    ECOG status
    Units: Subjects
        Zero
    		 12 12
        One
    		 15 15
        Two
    		 3 3
        Three
    		 0 0
    Prior first line platinum based chemotherapy number of cycles
    Units: Number of cycles
        median (inter-quartile range (Q1-Q3))
    		 6 (6 to 6) -
    Total dose of prior radiotherapy
    Units: gray
        median (inter-quartile range (Q1-Q3))
    		 20.0 (20.0 to 20.0) -
    Total fractions of radiotherapy
    Units: Fractions
        median (inter-quartile range (Q1-Q3))
    		 5 (5 to 5) -

    End points

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    End points reporting groups
    Reporting group title
    Paclitaxel +/- cediranib
    Reporting group description
    		 This is a single arm, phase II trial of cediranib 20mg/day with weekly paclitaxel 70mg/m2/week in patients with recurrent platinum-resistant ovarian cancer and clinical and/or radiological features indicating an increased risk of developing subacute bowel obstruction. At the point of developing progressive disease (PD), participants cease paclitaxel and have the option of continuing cediranib 20mg/day with olaparib 300mg bd twice daily continuously until further PD occurs.
    Reporting group title
    Paclitaxel +/- cediranib
    Reporting group description
    		 This is a single arm, phase II trial of cediranib 20mg/day with weekly paclitaxel 70mg/m2/week in patients with recurrent platinum-resistant ovarian cancer and clinical and/or radiological features indicating an increased risk of developing subacute bowel obstruction. At the point of developing progressive disease (PD), participants cease paclitaxel and have the option of continuing cediranib 20mg/day with olaparib 300mg bd twice daily continuously until further PD occurs.

    Primary: Grade III-V gastrointestinal perforation or fistula

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    End point title
    		 Grade III-V gastrointestinal perforation or fistula [1]
    End point description
    End point type
    Primary
    End point timeframe
    During treatment with cediranib
    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: The primary endpoint was summarised as the proportion of patients with objective response with an exact 95% confidence interval in the ITT population. No statistical test was performed as this was primarily a safety trial.
    End point values
    		 Paclitaxel +/- cediranib
    Number of subjects analysed
    17 [2]
    Units: Subjects
        Yes
    0
        No
    17
    Notes
    [2] - 17 patients started treatment with cediranib. Two started in cycle 1 and the rest following paclitax
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Paclitaxel + cediranib
    Reporting group description
    		 This is a single arm, phase II trial of cediranib 20mg/day with weekly paclitaxel 70mg/m2/week in patients with recurrent platinum-resistant ovarian cancer and clinical and/or radiological features indicating an increased risk of developing subacute bowel obstruction. At the point of developing progressive disease (PD), participants cease paclitaxel and have the option of continuing cediranib 20mg/day with olaparib 300mg bd twice daily continuously until further PD occurs.

    Reporting group title
    Olaparib+cediranib
    Reporting group description
    		 -

    Reporting group title
    Paclitaxel only
    Reporting group description
    		 -

    Serious adverse events
    		 Paclitaxel + cediranib Olaparib+cediranib Paclitaxel only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 17 (35.29%)
    1 / 5 (20.00%)
    5 / 12 (41.67%)
         number of deaths (all causes)
    7
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Hypocalcaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Paclitaxel + cediranib Olaparib+cediranib Paclitaxel only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    4 / 5 (80.00%)
    12 / 12 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 17 (47.06%)
    1 / 5 (20.00%)
    3 / 12 (25.00%)
         occurrences all number
    27
    1
    4
    Thromboembolic event
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    4
    0
    3
    Hot flush
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Transient ischaemic attack
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Surgical and medical procedures
    Reaction to paclitaxel
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    15 / 17 (88.24%)
    2 / 5 (40.00%)
    8 / 12 (66.67%)
         occurrences all number
    65
    12
    16
    Oedema peripheral
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    1
    4
    Pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    3
    Immune system disorders
    Allergic reaction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    2
    Anaphylaxis
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    3
    0
    1
    Hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 17 (41.18%)
    2 / 5 (40.00%)
    0 / 12 (0.00%)
         occurrences all number
    17
    4
    0
    Dyspnoea
         subjects affected / exposed
    5 / 17 (29.41%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    16
    9
    3
    Hoarseness
         subjects affected / exposed
    4 / 17 (23.53%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    7
    0
    0
    Epistaxis
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    5
    0
    1
    Nasal congestion
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    7
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    0
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    3
    Insomnia
         subjects affected / exposed
    4 / 17 (23.53%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    18
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    8 / 17 (47.06%)
    3 / 5 (60.00%)
    4 / 12 (33.33%)
         occurrences all number
    24
    10
    4
    Alkaline phosphatase increased
         subjects affected / exposed
    6 / 17 (35.29%)
    0 / 5 (0.00%)
    4 / 12 (33.33%)
         occurrences all number
    19
    0
    7
    Blood bilirubin increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    1
    Creatinine urine increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    0
    ECG QTc prolonged
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    8 / 17 (47.06%)
    1 / 5 (20.00%)
    4 / 12 (33.33%)
         occurrences all number
    13
    5
    5
    Platelet count decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Blood folate decreased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    9
    0
    0
    Blood iron decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    6
    0
    1
    Weight decreased
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    2
    3
    1
    Weight increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 5 (40.00%)
    0 / 12 (0.00%)
         occurrences all number
    6
    5
    0
    Palpitations
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    9
    0
    Sinus bradycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    9
    4
    0
    Dysgeusia
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    11
    1
    0
    Headache
         subjects affected / exposed
    6 / 17 (35.29%)
    2 / 5 (40.00%)
    1 / 12 (8.33%)
         occurrences all number
    8
    5
    1
    Ischemia cerebrovascular
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    6
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    13 / 17 (76.47%)
    3 / 5 (60.00%)
    2 / 12 (16.67%)
         occurrences all number
    88
    18
    4
    Reversible posterior leukoencephalopathy syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Amnesia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Anxiety
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    12
    3
    0
    Depressed mood
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Depression
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    0
    Lethargy
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    6
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    3
    Seizure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Tremor
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    9 / 17 (52.94%)
    1 / 5 (20.00%)
    9 / 12 (75.00%)
         occurrences all number
    40
    8
    17
    Febrile neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Vertigo
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    9
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    11 / 17 (64.71%)
    2 / 5 (40.00%)
    8 / 12 (66.67%)
         occurrences all number
    30
    4
    13
    Diarrhoea
         subjects affected / exposed
    16 / 17 (94.12%)
    4 / 5 (80.00%)
    5 / 12 (41.67%)
         occurrences all number
    127
    17
    9
    Dyspepsia
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 5 (20.00%)
    4 / 12 (33.33%)
         occurrences all number
    6
    2
    8
    Infectious colitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Mucositis oral
         subjects affected / exposed
    8 / 17 (47.06%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    18
    1
    1
    Nausea
         subjects affected / exposed
    14 / 17 (82.35%)
    3 / 5 (60.00%)
    9 / 12 (75.00%)
         occurrences all number
    47
    13
    14
    Vomiting
         subjects affected / exposed
    9 / 17 (52.94%)
    2 / 5 (40.00%)
    6 / 12 (50.00%)
         occurrences all number
    19
    6
    6
    Other non-infectious GE or colitis
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal distension
         subjects affected / exposed
    5 / 17 (29.41%)
    2 / 5 (40.00%)
    3 / 12 (25.00%)
         occurrences all number
    15
    6
    5
    Abdominal mass
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    2
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Angular cheilitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Ascites
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    4
    0
    6
    Dry mouth
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    6
    0
    0
    Abdominal pain
         subjects affected / exposed
    13 / 17 (76.47%)
    3 / 5 (60.00%)
    10 / 12 (83.33%)
         occurrences all number
    82
    14
    20
    Abdominal infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    4
    Bile duct stenosis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Gastrointestinal sounds abnormal
         subjects affected / exposed
    11 / 17 (64.71%)
    1 / 5 (20.00%)
    4 / 12 (33.33%)
         occurrences all number
    42
    1
    8
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    7
    0
    3
    Gingivitis
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    0
    Intestinal obstruction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    Oral candidiasis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Oral pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Proctalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Perihepatic discomfort
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    9 / 17 (52.94%)
    1 / 5 (20.00%)
    5 / 12 (41.67%)
         occurrences all number
    45
    1
    7
    Contusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    4
    0
    1
    Hyperkeratosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    6
    0
    0
    Laceration
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    2
    0
    Nail discolouration
         subjects affected / exposed
    3 / 17 (17.65%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    8
    1
    0
    Nail disorder
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    26
    1
    0
    Onychomadesis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    4
    0
    0
    Rash
         subjects affected / exposed
    5 / 17 (29.41%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    16
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Bladder pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Renal colic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Hypothyroidism
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 17 (29.41%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    20
    1
    1
    Back pain
         subjects affected / exposed
    5 / 17 (29.41%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    22
    0
    1
    Groin pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    12
    0
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    7
    0
    0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    9 / 17 (52.94%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    21
    2
    2
    COVID-19
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Fungal infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    Lung infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Pelvic infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Tinea infections
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth abscess
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Wound infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    2
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    7 / 17 (41.18%)
    2 / 5 (40.00%)
    4 / 12 (33.33%)
         occurrences all number
    64
    15
    9
    Dehydration
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    6
    0
    2
    Decreased appetite
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Folate deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    2
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 5 (40.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    6
    0
    Hypocalcaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    0
    Hypomagnesaemia
         subjects affected / exposed
    4 / 17 (23.53%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    15
    3
    1
    Iron deficiency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    5
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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