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    Clinical Trial Results:
    A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

    Summary
    EudraCT number
    		 2010-022971-79
    Trial protocol
    		 CZ   PL   HU  
    Global end of trial date
    27 Mar 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Apr 2016
    First version publication date
    17 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PALO-10-14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01395901
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinn Healthcare SA
    Sponsor organisation address
    Via Pian Scairolo 9, Lugano/Pazzallo, Switzerland, 6912
    Public contact
    Salvatore Chessari, Helsinn Healthcare SA, +41 91 985 21 21, salvatore.chessari@helsinn.com
    Scientific contact
    Salvatore Chessari, Helsinn Healthcare SA, +41 91 985 21 21, salvatore.chessari@helsinn.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
    05 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objectives of the trial: - The primary objective of this study is to evaluate the efficacy of a single palonosetron intravenous (IV) dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting (PONV) through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia.
    Protection of trial subjects
    For all patients, written informed consent signed by the parent(s)/legal guardian(s) was obtained prior to enrollment. For patients of appropriate age and intellectual maturity, the signed assent form was obtained in compliance with local laws and regulations.
    Background therapy
    		 NA
    Evidence for comparator
    		 Ondansetron (Zofran®) was selected as the active comparator since this drug is considered to be the current standard of care in the US for the prevention of PONV in pediatric surgical patients.
    Actual start date of recruitment
    14 Jun 2011
    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
    Poland: 54
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    Hungary: 221
    Country: Number of subjects enrolled
    United States: 166
    Country: Number of subjects enrolled
    Russian Federation: 71
    Country: Number of subjects enrolled
    Ukraine: 125
    Country: Number of subjects enrolled
    Argentina: 13
    Worldwide total number of subjects
    670
    EEA total number of subjects
    295
    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)
    47
    Children (2-11 years)
    487
    Adolescents (12-17 years)
    136
    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
    		 A total of 44 sites were initiated in seven countries with 12, 9, 5, 5, 5, 6 and 2 investigative sites in the United States, Ukraine, Hungary, Poland, Russia, Czech Republic and Argentina. Patients were enrolled into the study by 39 out of 44 Investigators enrolling at least one patient.

    Pre-assignment
    Screening details
    		 Out of total 670 randomised patients, 9 patients (5 in Palonosetron and Placebo to Ondansetron group and 4 in Ondansetron and Placebo to Palonosetron group), did not receive the study drug and hence were not included in the Full Analysis Set (FAS) population.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Palonosetron and Placebo to Ondansetron
    Arm description
    		 Intervention: Drug: Palonosetron Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) Placebo to Ondansetron
    Arm type
    		 Experimental

    Investigational medicinal product name
    Palonosetron
    Investigational medicinal product code
    NA
    Other name
    Aloxi
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg).

    Investigational medicinal product name
    Placebo to Ondansetron
    Investigational medicinal product code
    NA
    Other name
    NA
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose matching placebo IV.

    Arm title
    		 Ondansetron and Placebo to Palonosetron
    Arm description
    		 Intervention: Drug: Comparator: Ondansetron Ondansetron: Single dose Ondansetron IV: 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg; 13 years to less than 17 years dose: 4 mg Placebo to Palonosetron
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ondansetron
    Investigational medicinal product code
    NA
    Other name
    Zofran
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose Ondansetron IV: 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg; 13 years to less than 17 years dose: 4 mg.

    Investigational medicinal product name
    Placebo to Palonosetron
    Investigational medicinal product code
    NA
    Other name
    NA
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose matching placebo IV.

    Number of subjects in period 1 [1]
    		Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Started
    331
    330
    Completed
    326
    329
    Not completed
    5
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    4
    -
    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: Out of total 670 randomised patients, 9 patients (5 in Palonosetron and Placebo to Ondansetron group and 4 in Ondansetron and Placebo to Palonosetron group), did not receive the study drug and hence were not included in the Full Analysis Set (FAS) population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Palonosetron and Placebo to Ondansetron
    Reporting group description
    		 Intervention: Drug: Palonosetron Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) Placebo to Ondansetron

    Reporting group title
    Ondansetron and Placebo to Palonosetron
    Reporting group description
    		 Intervention: Drug: Comparator: Ondansetron Ondansetron: Single dose Ondansetron IV: 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg; 13 years to less than 17 years dose: 4 mg Placebo to Palonosetron

    Reporting group values
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron Total
    Number of subjects
    		 331 330 661
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.82 ± 4.44 7.43 ± 4.32 -
    Gender categorical
    Units: Subjects
        Female
    		 132 129 261
        Male
    		 199 201 400
    Age customized
    Units: Subjects
        <2 years
    		 22 24 46
        2 <6 years
    		 124 123 247
        6 <12 years
    		 117 117 234
        12 <17 years
    		 68 66 134
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 24 21 45
        Not Hispanic or Latino
    		 307 309 616
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Asian
    		 1 1 2
        Black or African American
    		 13 12 25
        White
    		 315 312 627
        More than one race
    		 0 1 1
        Unknown or Not Reported
    		 2 3 5

    End points

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    End points reporting groups
    Reporting group title
    Palonosetron and Placebo to Ondansetron
    Reporting group description
    		 Intervention: Drug: Palonosetron Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) Placebo to Ondansetron

    Reporting group title
    Ondansetron and Placebo to Palonosetron
    Reporting group description
    		 Intervention: Drug: Comparator: Ondansetron Ondansetron: Single dose Ondansetron IV: 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg; 13 years to less than 17 years dose: 4 mg Placebo to Palonosetron

    Primary: Proportion of Patients With Complete Response

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    End point title
    		 Proportion of Patients With Complete Response
    End point description
    Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. The Full Analysis Set (FAS) included all randomized patients who received the active study drug, general anesthesia and surgery (evaluable patients). Following the intent-to-treat principle, patients were assigned to the study treatment arm according to their randomized treatment.
    End point type
    Primary
    End point timeframe
    0-24 hours after T0
    End point values
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Number of subjects analysed
    331
    330
    Units: percentage of patients
        number (confidence interval 95%)
    78.2 (73.3 to 82.5)
    82.7 (78.1 to 86.6)
    Statistical analysis title
    		 Comparison of Proportion of Patients With Complete
    Statistical analysis description
    The null hypothesis (H0) was stated as: • H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron <-10% The alternative hypothesis (H1) was stated as: • H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron >-10% A power of 80% was used for sample size computation.
    Comparison groups
    Palonosetron and Placebo to Ondansetron v Ondansetron and Placebo to Palonosetron
    Number of subjects included in analysis
    661
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 1.7
    Notes
    [1] - For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.

    Secondary: Proportion of Patients With no Vomiting

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    End point title
    		 Proportion of Patients With no Vomiting
    End point description
    Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. The Full Analysis Set (FAS) population.
    End point type
    Secondary
    End point timeframe
    0-24 hours after T0
    End point values
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Number of subjects analysed
    331
    330
    Units: percentage of patients
        number (confidence interval 95%)
    83.1 (78.5 to 86.9)
    87.6 (83.4 to 90.8)
    No statistical analyses for this end point

    Secondary: Proportion of Patients Without Emetic Episodes

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    End point title
    		 Proportion of Patients Without Emetic Episodes
    End point description
    An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. The Full Analysis Set (FAS) population.
    End point type
    Secondary
    End point timeframe
    0-24 hours after T0
    End point values
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Number of subjects analysed
    331
    330
    Units: percentage of patients
        number (confidence interval 95%)
    80.1 (75.3 to 84.1)
    83.9 (79.4 to 87.6)
    No statistical analyses for this end point

    Secondary: Proportion of Patients Without Antiemetic Rescue Medication

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    End point title
    		 Proportion of Patients Without Antiemetic Rescue Medication
    End point description
    Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively. The Full Analysis Set (FAS) population.
    End point type
    Secondary
    End point timeframe
    0-24 hours after T0
    End point values
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Number of subjects analysed
    331
    330
    Units: percentage of patients
        number (confidence interval 95%)
    93.1 (89.6 to 95.4)
    96.4 (93.6 to 98)
    No statistical analyses for this end point

    Secondary: Proportion of Patients Without Nausea (Patient Aged > 6 Years)

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    End point title
    		 Proportion of Patients Without Nausea (Patient Aged > 6 Years)
    End point description
    Included patients in the Full Analysis Set (FAS) population who were aged ≥ 6 years.
    End point type
    Secondary
    End point timeframe
    0-24 hours after T0
    End point values
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Number of subjects analysed
    185
    183
    Units: percentage of patients
        number (confidence interval 95%)
    83.2 (76.9 to 88.2)
    82 (75.5 to 87.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days post treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Palonosetron and Placebo to Ondansetron
    Reporting group description
    		 Intervention: Drug: Palonosetron Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg) Placebo to Ondansetron

    Reporting group title
    Ondansetron and Placebo to Palonosetron
    Reporting group description
    		 Intervention: Drug: Comparator: Ondansetron Ondansetron: Single dose Ondansetron IV: 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg; 13 years to less than 17 years dose: 4 mg Placebo to Palonosetron

    Serious adverse events
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 331 (1.21%)
    11 / 330 (3.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioma
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 331 (0.30%)
    5 / 330 (1.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric anastomosis complication
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 331 (0.30%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palatal oedema
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulpitis dental
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 331 (0.30%)
    0 / 330 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 331 (0.30%)
    2 / 330 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 331 (0.00%)
    1 / 330 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Palonosetron and Placebo to Ondansetron Ondansetron and Placebo to Palonosetron
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    212 / 331 (64.05%)
    203 / 330 (61.52%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    147 / 331 (44.41%)
    123 / 330 (37.27%)
         occurrences all number
    149
    126
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 331 (1.21%)
    10 / 330 (3.03%)
         occurrences all number
    4
    10
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    2 / 331 (0.60%)
    12 / 330 (3.64%)
         occurrences all number
    2
    19
    Pain
         subjects affected / exposed
    15 / 331 (4.53%)
    15 / 330 (4.55%)
         occurrences all number
    16
    16
    Pyrexia
         subjects affected / exposed
    22 / 331 (6.65%)
    25 / 330 (7.58%)
         occurrences all number
    22
    30
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    6 / 331 (1.81%)
    9 / 330 (2.73%)
         occurrences all number
    6
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 331 (0.60%)
    8 / 330 (2.42%)
         occurrences all number
    2
    8
    Vomiting
         subjects affected / exposed
    5 / 331 (1.51%)
    10 / 330 (3.03%)
         occurrences all number
    5
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 331 (2.11%)
    5 / 330 (1.52%)
         occurrences all number
    7
    5
    Oropharyngeal pain
         subjects affected / exposed
    27 / 331 (8.16%)
    37 / 330 (11.21%)
         occurrences all number
    28
    39
    Skin and subcutaneous tissue disorders
    Scar
         subjects affected / exposed
    7 / 331 (2.11%)
    4 / 330 (1.21%)
         occurrences all number
    7
    4

    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.
    Enrollment of non-white or Hispanic patients was low and limited assessment of any potential impact of these demographic characteristics.
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