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    Clinical Trial Results:
    A Multicenter, Open-Label, Ascending Multiple-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age With Selected Serious Infections

    Summary
    EudraCT number
    		 2007-002120-14
    Trial protocol
    		 BE   GB   Outside EU/EEA  
    Global end of trial date
    25 Sep 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    05 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3074K4-2207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00488345
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., +1 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000120-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Mar 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the pharmacokinetics (PK) profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections (complicated intra-abdominal infection [cIAI], complicated skin and skin structure infection [cSSSI], or community-acquired pneumonia [CAP]).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on  Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Jan 2008
    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
    Taiwan: 1
    Country: Number of subjects enrolled
    Ukraine: 26
    Country: Number of subjects enrolled
    United States: 19
    Country: Number of subjects enrolled
    South Africa: 12
    Worldwide total number of subjects
    58
    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)
    58
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Fifty-nine subjects were screened and enrolled in the study, and 58 subjects received at least 1 dose of tigecycline.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tigecycline 0.75 mg/kg
    Arm description
    		 0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tigecycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 0.75 mg/kg of tigecycline was administered as IV infusion every 12 hours.

    Arm title
    		 Tigecycline 1 mg/kg
    Arm description
    		 1 mg/kg IV infusion every 12 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tigecycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 1 mg/kg of tigecycline was administered as IV infusion every 12 hours.

    Arm title
    		 Tigecycline 1.25 mg/kg
    Arm description
    		 1.25 mg/kg IV infusion every 12 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tigecycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A dose of 1.25 mg/kg of tigecycline was administered as IV infusion every 12 hours.

    Number of subjects in period 1
    		Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg
    Started
    17
    21
    20
    Completed
    17
    17
    17
    Not completed
    0
    4
    3
         Unable to administer antibiotics at home
    -
    1
    -
         Parent/legal guardian request
    -
    1
    1
         Adverse event
    -
    1
    1
         Institutional Review Board review
    -
    -
    1
         Surgical team recommendation
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tigecycline 0.75 mg/kg
    Reporting group description
    		 0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours

    Reporting group title
    Tigecycline 1 mg/kg
    Reporting group description
    		 1 mg/kg IV infusion every 12 hours

    Reporting group title
    Tigecycline 1.25 mg/kg
    Reporting group description
    		 1.25 mg/kg IV infusion every 12 hours

    Reporting group values
    		 Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg Total
    Number of subjects
    		 17 21 20 58
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.21 ± 1.15 10.2 ± 1.06 9.72 ± 0.94 -
    Gender, Male/Female
    Units: subjects
        Female
    		 9 10 8 27
        Male
    		 8 11 12 31
    Selected Serious Infections
    Units: Subjects
        Community Acquired Pneumonia
    		 7 8 4 19
        Complicated Intra-abdominal Infection
    		 6 6 12 24
        Complicated Skin and Skin Structure Infection
    		 4 7 4 15

    End points

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    End points reporting groups
    Reporting group title
    Tigecycline 0.75 mg/kg
    Reporting group description
    		 0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours

    Reporting group title
    Tigecycline 1 mg/kg
    Reporting group description
    		 1 mg/kg IV infusion every 12 hours

    Reporting group title
    Tigecycline 1.25 mg/kg
    Reporting group description
    		 1.25 mg/kg IV infusion every 12 hours

    Subject analysis set title
    Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    0.75, 1 mg/kg, and 1.25 mg/kg IV infusions every 12 hours

    Primary: Maximum Observed Plasma Concentration (Cmax)

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) [1]
    End point description
    Cmax: tigecycline serum concentration measured in nanograms per milliliter (ng/mL) determined by a validated liquid chromatography with mass spectrophotometric (LC/MS/MS) detection method. Peak concentration was taken directly from the observed data. Modified intent to treat (mITT) population: subjects who were screened, assigned to study medication and received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Day 3 (immediately post-dose, 0.75, 2 hours post-dose)
    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: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    		 Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg
    Number of subjects analysed
    17
    19 [2]
    16 [3]
    Units: ng/mL
        arithmetic mean (standard deviation)
    456 ± 347
    1515 ± 1457
    2599 ± 3643
    Notes
    [2] - N = number of subjects with evaluable tigecycline concentration data.
    [3] - N = number of subjects with evaluable tigecycline concentration data.
    No statistical analyses for this end point

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax)

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) [4]
    End point description
    Time of peak concentration taken directly from the observed data. mITT population.
    End point type
    Primary
    End point timeframe
    Day 3 (immediately post-dose, 0.75, 2 hours post-dose)
    Notes
    [4] - 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: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    		 Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg
    Number of subjects analysed
    17
    19 [5]
    16 [6]
    Units: hours
        arithmetic mean (standard deviation)
    0.6 ± 0.2
    0.5 ± 0.1
    0.8 ± 0.6
    Notes
    [5] - N = number of subjects with evaluable tigecycline concentration data.
    [6] - N = number of subjects with evaluable tigecycline concentration data.
    No statistical analyses for this end point

    Primary: Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours

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    End point title
    		 Area Under the Curve (AUCτ) From Time Zero to Time of Estimated Concentration at 12 Hours [7]
    End point description
    AUCτ: AUC between doses from time zero to the time of estimated concentration at 12 hours reported in nanograms * hours divided by milliliters (ng*h/mL) was calculated using the log-trapezoidal rule for decreasing concentrations and the linear-trapezoidal rule for increasing concentrations estimating the 12 hour drug concentration if necessary. mITT population.
    End point type
    Primary
    End point timeframe
    Day 3 (just before and immediately after infusion, 0.75, 2, 6 hours post-dose)
    Notes
    [7] - 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: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    		 Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg
    Number of subjects analysed
    16 [8]
    18 [9]
    13 [10]
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    1650 ± 529
    2557 ± 1196
    3196 ± 1704
    Notes
    [8] - N = number of subjects with sufficient reported tigecycline concentration data to estimate AUC.
    [9] - N = number of subjects with sufficient reported tigecycline concentration data to estimate AUC.
    [10] - N = number of subjects with sufficient reported tigecycline concentration data to estimate AUC.
    No statistical analyses for this end point

    Primary: Weight Normalized Drug Clearance (CLW)

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    End point title
    		 Weight Normalized Drug Clearance (CLW) [11]
    End point description
    Weight normalized drug clearance measured in liters per hour per kilogram (L/hr/kg). Drug clearance (CL) was determined as the ratio of dose/area under the concentration-time curve from time zero (start of infusion) to 12 hours (start of next infusion) (AUCτ). CLW was determined as the ratio of CL/weight. mITT population.
    End point type
    Primary
    End point timeframe
    Day 3 (just before and immediately after infusion, 0.75, 2, 6 hours post-dose)
    Notes
    [11] - 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: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    		 Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg
    Number of subjects analysed
    16 [12]
    18 [13]
    13 [14]
    Units: L/hr/kg
        arithmetic mean (standard deviation)
    0.49 ± 0.13
    0.498 ± 0.335
    0.528 ± 0.384
    Notes
    [12] - N = number of subjects with sufficient reported tigecycline concentration data to estimate AUC.
    [13] - N = number of subjects with sufficient reported tigecycline concentration data to estimate AUC.
    [14] - N = number of subjects with sufficient reported tigecycline concentration data to estimate AUC.
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment

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    End point title
    		 Percentage of Subjects With Clinical Response (CR) to Tigecycline at Last Day of Therapy (LDOT) and Test-of-Cure (TOC) Assessment [15]
    End point description
    CR = Cure: resolution of all signs, symptoms (SS) of infection (INF) or improvement, no further antibacterial therapy (AT) necessary; Improved (IMP): SS IMP to extent that switch to oral AT deemed appropriate; Failure: lack of response, required additional AT, initial recovery then deterioration requiring further AT, death due to the INF after day 2, death due to treatment (TR)-related adverse event (AE), required non-routine surgical TR >48 hours after 1st dose of TR due to failure to IMP or clinical worsening. TOC = CR, vital signs, physical exam, laboratory results, concomitant TR, and AEs. mITT population.
    End point type
    Primary
    End point timeframe
    Day 14 or LDOT, TOC Visit (10 to 21 days after last dose of total antibiotic therapy)
    Notes
    [15] - 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: Only descriptive data was planned to be reported for this outcome measure.
    End point values
    		 Tigecycline 0.75 mg/kg Tigecycline 1 mg/kg Tigecycline 1.25 mg/kg
    Number of subjects analysed
    17
    21
    20
    Units: percentage of subjects
    number (not applicable)
        Cure: LDOT
    82.4
    52.4
    30
        Improved: LDOT
    17.6
    28.6
    55
        Failure: LDOT
    0
    0
    0
        Indeterminate: LDOT
    0
    19
    15
        Cure: TOC
    94.1
    76.2
    75
        Failure: TOC
    5.9
    4.8
    10
        Indeterminate: TOC
    0
    19
    15
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetic (PK) Model: Volume of Distribution

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    End point title
    		 Population Pharmacokinetic (PK) Model: Volume of Distribution
    End point description
    Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin. Separate population pharmacokinetic analysis results were not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.
    End point type
    Secondary
    End point timeframe
    3074K4-2207: Day 3 just before and immediately after infusion, 0.75, 2, 6 hours post-dose; 3074A1-110: just before, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, 48 hours after start of infusion
    End point values
    		 Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg
    Number of subjects analysed
    0 [16]
    Units: liters
        arithmetic mean (standard error)
    ±
    Notes
    [16] - Separate population pharmacokinetic analysis results were not available for the study.
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetic (PK) Model: Clearance

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    End point title
    		 Population Pharmacokinetic (PK) Model: Clearance
    End point description
    Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin. Separate population pharmacokinetic analysis results were not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.
    End point type
    Secondary
    End point timeframe
    3074K4-2207: Day 3 just before and immediately after infusion, 0.75, 2, 6 hours post-dose; 3074A1-110: just before, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, 48 hours after start of infusion
    End point values
    		 Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg
    Number of subjects analysed
    0 [17]
    Units: liters per hour
        arithmetic mean (standard error)
    ±
    Notes
    [17] - Separate population pharmacokinetic analysis results were not available for the study.
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetic (PK) Model: Effect of Weight

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    End point title
    		 Population Pharmacokinetic (PK) Model: Effect of Weight
    End point description
    Two compartment model with linear clearance and effect of weight on clearance using pooled PK data from 2 pediatric studies. All concentration-time data were combined and analyzed using population PK methods to investigate potential influence of age, weight, and height (dose, tigecycline concentrations, times, subject weight, height, age, body surface area, serum creatinine, estimated creatinine clearance, serum bilirubin. Separate population pharmacokinetic analysis results were not available for the current study as more than 1 study was involved in this analysis based on pooled data from pediatric studies 3074A1-110 and 3074K4-2207.
    End point type
    Secondary
    End point timeframe
    3074K4-2207: Day 3 just before and immediately after infusion, 0.75, 2, 6 hours post-dose; 3074A1-110: just before, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 36, 48 hours after start of infusion
    End point values
    		 Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg
    Number of subjects analysed
    0 [18]
    Units: units on a scale
        arithmetic mean (standard error)
    ±
    Notes
    [18] - Separate population pharmacokinetic analysis results were not available for the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 21 days after the last dose of study drug
    Adverse event reporting additional description
    mITT population. An Adverse Event(AE) term may be reported as both a serious and a non-serious AE, but are distinct events. AE may be serious for one subject and non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Tigecycline 0.75 mg/kg
    Reporting group description
    		 0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours

    Reporting group title
    Tigecycline 1.25 mg/kg
    Reporting group description
    		 1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours

    Reporting group title
    Tigecycline 1 mg/kg
    Reporting group description
    		 1 milligram per kilogram (mg/kg) IV infusion every 12 hours

    Serious adverse events
    		 Tigecycline 0.75 mg/kg Tigecycline 1.25 mg/kg Tigecycline 1 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Tigecycline 0.75 mg/kg Tigecycline 1.25 mg/kg Tigecycline 1 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 17 (64.71%)
    17 / 20 (85.00%)
    16 / 21 (76.19%)
    Vascular disorders
    Bloody discharge
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Phlebitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Catheter site related reaction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Crepitations
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Pleural effusion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    Amylase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    1
    Fungal test positive
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Blood phosphorus increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Blood urea increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Blood calcium decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Platelet count increased
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Lipase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 20 (10.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    2
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    2
    Medical device pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Wound dehiscence
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    2
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    2
    Dysgeusia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombocytosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Chapped lips
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    1
    Lip dry
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    5 / 17 (29.41%)
    11 / 20 (55.00%)
    11 / 21 (52.38%)
         occurrences all number
    6
    20
    21
    Ileus
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    3 / 17 (17.65%)
    12 / 20 (60.00%)
    13 / 21 (61.90%)
         occurrences all number
    3
    18
    19
    Pancreatitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Bladder discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Osteopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Postoperative wound infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 20 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    Decreased appetite
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    2

    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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    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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