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    Clinical Trial Results:
    A multicentre phase IIa study to evaluate the efficacy and tolerability of ModraDoc006/r in patients with recurrent or metastatic HER-2 negative breast cancer, suitable for treatment with a taxane

    Summary
    EudraCT number
    		 2018-003249-41
    Trial protocol
    		 BE   DK   ES  
    Global end of trial date
    13 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Nov 2022
    First version publication date
    06 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M18DMB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03890744
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Modra Pharmaceuticals
    Sponsor organisation address
    Barbara Strozzilaan 201, Amsterdam, Netherlands, 1083 HN
    Public contact
    Project Director, Modra Pharmaceuticals, +31 2050188, info@modrapharmaceuticals.com
    Scientific contact
    Project Director, Modra Pharmaceuticals, +31 2050188, info@modrapharmaceuticals.com
    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
    12 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of ModraDoc006/r (oral docetaxel formulation given as ModraDoc006 10 mg tablets in combination with ritonavir 100 mg tablets) as measured by RECIST v1.1 criteria of objective response rate (ORR) in patients with histologically and cytologically confirmed, recurrent or metastatic HER-2 negative breast cancer suitable for treatment with a taxane.
    Protection of trial subjects
    To minimize the risk to patients and maximize safety, the following factors were incorporated into the trial design: • Detailed safety and laboratory assessments were be performed. • As anti-emetic therapy, all subjects were given bi-daily 1 mg of granisetron 1 hour prior to oral ModraDoc006/r administration during the first two cycles. In subsequent cycles, granisetron premedication could be given if indicated. All subjects were provided by the site with a home prescription for anti-emetics (metoclopramide 10 mg maximum four times daily) and received instructions on how to use this medication in case nausea/vomiting occurred at home. If this proved insufficient, dexamethasone and lorazepam could be added as anti-emetic treatment. In case of vomiting after intake, the subjects did not take any new anti-emetic therapy • Patients were provided with diet and hydration instructions and a home prescription for loperamide, with instructions on how to use this medication in case diarrhea occurred at home • All clinical observations were evaluated by the Investigator on an ongoing basis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2018
    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
    Belgium: 7
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Denmark: 4
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    5
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Prior to obtaining informed consent, the purpose and nature of the trial as well as possible adverse effects resulting from trial drug administration were explained to each subject. Written informed consent was obtained, before any trial-specific procedures were performed.

    Pre-assignment
    Screening details
    		 Between 11Feb2019 and 09Jul2019, informed consent was obtained from 13 subjects with metastatic HER-2-negative breast cancer. One subject experienced elevated liver enzymes outside the allowed range for inclusion prior to investigational medicinal product (IMP) administration and was therefore excluded from receiving the trial drug.

    Pre-assignment period milestones
    Number of subjects started
    		 13
    Number of subjects completed
    		 12

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Period 1
    Period 1 title
    Treated (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ModraDoc006/r
    Arm description
    		 Patients received ModraDoc006 30 mg in combination with ritonavir 100 mg in the morning and ModraDoc006 20 mg in combination with 100 mg ritonavir in the afternoon (7 to 12 hours after the morning dose), on Day 1 of weekly cycles (BIDW: bi-daily once weekly dosing).
    Arm type
    		 Experimental

    Investigational medicinal product name
    ModraDoc006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Bi-daily once weekly (BIDW) 30 mg in in the morning and 20 mg in the afternoon

    Investigational medicinal product name
    ritonavir
    Investigational medicinal product code
    /r
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Bi-daily once weekly (BIDW) 100 mg in the morning and 100 mg in the evening

    Number of subjects in period 1 [1]
    		ModraDoc006/r
    Started
    12
    Completed
    12
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One patient was enrolled, but did not start treatment due to elevated liver enzymes outside the allowed range for inclusion experienced prior to IMP administration.

    Baseline characteristics

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

    Reporting group values
    		 Treated Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 5 5
        From 65-84 years
    		 7 7
    Age continuous
    Units: years
        median (full range (min-max))
    		 66.0 (48 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 0 0
    Child-bearing potential
    Units: Subjects
        Yes
    		 0 0
        No
    		 12 12
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1
        Not Hispanic or Latino
    		 10 10
        Unknown
    		 1 1
    Race
    Units: Subjects
        White
    		 12 12
    Staging at primary cancer diagnosis
    Units: Subjects
        Ia
    		 2 2
        II
    		 2 2
        IIa
    		 1 1
        IIb
    		 1 1
        IIIa
    		 3 3
        IV
    		 2 2
        Missing
    		 1 1
    Occurrence of metastasis
    Units: Subjects
        Yes
    		 12 12
        No
    		 0 0
    WHO Performance Status
    Units: Subjects
        PS 0
    		 8 8
        PS 1
    		 4 4
    Location of metastasis: Bone
    Units: Subjects
        Yes
    		 9 9
        No
    		 3 3
    Location of metastasis: Liver
    Units: Subjects
        Yes
    		 4 4
        No
    		 8 8
    Location of metastasis: Lungs
    Units: Subjects
        Yes
    		 1 1
        No
    		 11 11
    Previous cancer therapy: Radiotherapy
    Units: Subjects
        Yes
    		 8 8
        No
    		 4 4
    Previous cancer therapy: Surgery
    Units: Subjects
        Yes
    		 9 9
        No
    		 3 3
    Previous cancer therapy: Systemic regimen (adjuvant)
    Units: Subjects
        Yes
    		 9 9
        No
    		 3 3
    Previous cancer therapy: Systemic regimen (Metastatic)
    Units: Subjects
        Yes
    		 11 11
        No
    		 1 1
    Previous cancer therapy: Chemotherapy (adjuvant)
    Units: Subjects
        Yes
    		 8 8
        No
    		 4 4
    Previous cancer therapy: Chemotherapy (metastatic)
    Units: Subjects
        Yes
    		 3 3
        No
    		 9 9
    Previous cancer therapy: Taxane (adjuvant)
    Units: Subjects
        Yes
    		 3 3
        No
    		 9 9
    Height
    Units: centimetre
        median (full range (min-max))
    		 157.5 (141 to 173) -
    Weight
    Units: kilogram(s)
        median (full range (min-max))
    		 62.0 (38.4 to 83.0) -
    Body Mass Index (BMI)
    Units: kilogram(s)/square metre
        median (full range (min-max))
    		 24.2 (18.4 to 34.1) -
    Body Surface Area (BSA)
    Units: square metre
        median (full range (min-max))
    		 1.63 (1.22 to 1.86) -
    Median volumetric tumor size
    Sum of diameters of target lesions
    Units: millimetre(s)
        median (full range (min-max))
    		 63.0 (22.6 to 79.0) -
    Median biomarker level CA 15-3
    Units: unit(s)/millilitre
        median (full range (min-max))
    		 224.35 (21.48 to 447.30) -

    End points

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    End points reporting groups
    Reporting group title
    ModraDoc006/r
    Reporting group description
    		 Patients received ModraDoc006 30 mg in combination with ritonavir 100 mg in the morning and ModraDoc006 20 mg in combination with 100 mg ritonavir in the afternoon (7 to 12 hours after the morning dose), on Day 1 of weekly cycles (BIDW: bi-daily once weekly dosing).

    Subject analysis set title
    Evaluable for Radiological Response (ERR)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    The population evaluable for radiological response (ERR) was defined as subjects who received at least six weekly administrations of ModraDoc006/r, who had measurable lesions according to RECIST v1.1, and whose response had been evaluated using RECIST v1.1

    Primary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR) [1]
    End point description
    ORR according to RECIST v1.1
    End point type
    Primary
    End point timeframe
    During study period; radiological assessment at baseline, Week 8 and 12, and every 6 weeks thereafter until the end of treatment.
    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 objective response rate, ORR, was calculated as the proportion of subjects who achieved a CR or PR recorded from the start of the trial treatment until the end of treatment. ORR was summarised with 95% Clopper-Pearson Confidence Interval. PR = 37.5 % (8.52 – 75.5).
    End point values
    		 Evaluable for Radiological Response (ERR)
    Number of subjects analysed
    8
    Units: 0-12
        Complete response
    0
        Partial response
    3
        Stable disease
    4
        Progressive disease
    1
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    The DOR, calculated in the subpopulation of patients experiencing a CR or PR, is presented for patients that were evaluable for radiological response for the overall study.
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    Number of subjects analysed
    Units: month
    median (full range (min-max))
        CR
        PR
    No statistical analyses for this end point

    Secondary: Progression Free Survival

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    End point title
    		 Progression Free Survival
    End point description
    PFS was calculated as the time between the date of first dose of trial treatment (Day 1 of Cycle 1) and the first documented tumor progression or death from any cause. Tumor progression was defined as the occurrence of PD based on RECIST v1.1.
    End point type
    Secondary
    End point timeframe
    Overall study
    End point values
    		 Evaluable for Radiological Response (ERR)
    Number of subjects analysed
    8
    Units: month
        median (full range (min-max))
    5.7 (1.64 to 13.77)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored and collected from the time the patient gave informed consent and throughout the study until 30 days after the last ModraDoc006/r administration.
    Adverse event reporting additional description
    Safety analysis population assessed for all adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Safety population (SAF)
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population (SAF)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 12 (33.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chylothorax
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population (SAF)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    7
    Chest discomfort
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    17
    Localised oedema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Mucosal inflammation
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    4
    Mucosal toxicity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    5
    Dysphonia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    10
    Epistaxis
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    8
    Nasal dryness
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Pleural effusion
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Apathy
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Blood urine present
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Haematocrit decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Weight decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    White blood cell count decreased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Palpitations
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    5 / 12 (41.67%)
         occurrences all number
    5
    Facial paralysis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 12 (33.33%)
         occurrences all number
    4
    Lymphopenia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Neutropenia
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    4
    Thrombocytopenia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    4
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    4
    Abdominal pain
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    15
    Abdominal pain upper
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Anal fissure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Ascites
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    6 / 12 (50.00%)
         occurrences all number
    10
    Diarrhoea
         subjects affected / exposed
    10 / 12 (83.33%)
         occurrences all number
    21
    Dry mouth
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Dysphagia
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Faeces soft
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gingival pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Mouth ulceration
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    11 / 12 (91.67%)
         occurrences all number
    21
    Odynophagia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Oral toxicity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Stomatitis
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    7
    Tongue erythema
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    18
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    11
    Dry skin
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Madarosis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nail discolouration
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Nail ridging
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Nail toxicity
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Onycholysis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    9
    Rash
         subjects affected / exposed
    3 / 12 (25.00%)
         occurrences all number
    3
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    3
    Dactylitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3
    Groin pain
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Muscle fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Cystitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3
    Laryngitis
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Lung infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Paronychia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    2
    Skin infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Vaginal infection
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    9 / 12 (75.00%)
         occurrences all number
    20
    Dehydration
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypocalcaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Hypoproteinaemia
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    3

    More information

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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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