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    Clinical Trial Results:
    An Open-label, Multi-center Study to Evaluate the Disease Free Survival Rate of a Perioperative Combination of Capecitabine (Xeloda), Trastuzumab (Herceptin) and Oxaliplatin (XELOX-Trastuzumab) in Patients With Resectable Gastric or Gastro-esophageal Junction Adenocarcinoma (stages II-IV).

    Summary
    EudraCT number
    2009-017848-14
    Trial protocol
    ES  
    Global end of trial date
    10 Jun 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    ML25189
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01130337
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, CH-4070, Basel, Switzerland,
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.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
    10 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a Phase II, open-label, non-comparative, national, multicenter study with competitive recruitment to investigate the perioperative administration of one of the regimens considered to be standard in the treatment of Gastric Cancer (GC) in combination with trastuzumab.
    Protection of trial subjects
    Participants willing to participate were informed of the nature of the trial in detail and thereafter signed the informed consent form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Jul 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    25 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    16
    From 65 to 84 years
    19
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screening period comprised of 35 days. A total of 136 participants were included in the study out of which 36 participants were enrolled and 100 participants discontinued due to screening failures. Abbreviation of AE= adverse event.

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

    Arms
    Arm title
    Capecitabine+Oxaliplatin+Trastuzumab
    Arm description
    Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
    Arm type
    Experimental

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Xeloda
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received capecitabine 1,000 mg/m^2 tablet p.o twice daily, Days 1-14, every 3 weeks.

    Investigational medicinal product name
    Oxaliplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received oxaliplatin 130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle, every 3 weeks.

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received trastuzumab 8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion, every 3 weeks.

    Number of subjects in period 1
    Capecitabine+Oxaliplatin+Trastuzumab
    Started
    36
    Completed
    22
    Not completed
    14
         Death
    1
         Toxicity, AE/intercurrent disease
    7
         Principal investigator decision
    1
         Consent withdrawn by subject
    3
         Disease progression
    1
         Surgical resection (R2)
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Capecitabine+Oxaliplatin+Trastuzumab
    Reporting group description
    Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.

    Reporting group values
    Capecitabine+Oxaliplatin+Trastuzumab Total
    Number of subjects
    36 36
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    63.44 ± 10.42 -
    Gender, Male/Female
    Units: participants
        Female
    7 7
        Male
    29 29

    End points

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    End points reporting groups
    Reporting group title
    Capecitabine+Oxaliplatin+Trastuzumab
    Reporting group description
    Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.

    Primary: Percentage of Participants With Disease-free Survival (DFS) at Month 18

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    End point title
    Percentage of Participants With Disease-free Survival (DFS) at Month 18 [1]
    End point description
    DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occurred first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment). Intent-to-treat (ITT) population included all enrolled participants.
    End point type
    Primary
    End point timeframe
    Month 18
    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: As the study was non-comparative in nature, no statistical analysis was performed.
    End point values
    Capecitabine+Oxaliplatin+Trastuzumab
    Number of subjects analysed
    36
    Units: percentage of participants
        number (confidence interval 95%)
    76.12 (57.72 to 87.32)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Complete Tumor Resection (R0)

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    End point title
    Percentage of Participants With Complete Tumor Resection (R0)
    End point description
    R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation. ITT population. Here “number of participants analyzed” included those who underwent surgery.
    End point type
    Secondary
    End point timeframe
    Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
    End point values
    Capecitabine+Oxaliplatin+Trastuzumab
    Number of subjects analysed
    31
    Units: percentage of participants
        number (confidence interval 95%)
    90.32 (74.25 to 97.96)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Pathological Complete Response (pCR)

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    End point title
    Percentage of Participants With Pathological Complete Response (pCR)
    End point description
    pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery. ITT population.
    End point type
    Secondary
    End point timeframe
    Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
    End point values
    Capecitabine+Oxaliplatin+Trastuzumab
    Number of subjects analysed
    36
    Units: percentage of participants
        number (confidence interval 95%)
    8.33 (1.75 to 22.47)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Objective Response

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    End point title
    Percentage of Participants With Objective Response
    End point description
    An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions. ITT population.
    End point type
    Secondary
    End point timeframe
    Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
    End point values
    Capecitabine+Oxaliplatin+Trastuzumab
    Number of subjects analysed
    36
    Units: percentage of participants
        number (not applicable)
    38.89
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Before Day 1 of each cycle until Month 25
    Adverse event reporting additional description
    The safety analysis included all participants in the ITT population who received at least 1 dose of the study drugs.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Capecitabine+Oxaliplatin+Trastuzumab
    Reporting group description
    Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.

    Serious adverse events
    Capecitabine+Oxaliplatin+Trastuzumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 36 (61.11%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Procedural complication
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiogenic shock
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    1 / 36 (2.78%)
         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 / 36 (2.78%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sudden death
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pyrexia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Schizoaffective disorder
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Dysphagia
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Localised intra-abdominal fluid collection
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Appendicitis
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Capecitabine+Oxaliplatin+Trastuzumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 36 (97.22%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    5
    Ejection fraction decreased
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    4
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    13
    Catarrh
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    4
    Rhinorrhoea
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 36 (30.56%)
         occurrences all number
    13
    Thrombocytopenia
         subjects affected / exposed
    4 / 36 (11.11%)
         occurrences all number
    16
    Neutropenia
         subjects affected / exposed
    7 / 36 (19.44%)
         occurrences all number
    16
    Nervous system disorders
    Neurotoxicity
         subjects affected / exposed
    10 / 36 (27.78%)
         occurrences all number
    16
    Paraesthesia
         subjects affected / exposed
    6 / 36 (16.67%)
         occurrences all number
    11
    Dysaesthesia
         subjects affected / exposed
    7 / 36 (19.44%)
         occurrences all number
    18
    Neuropathy peripheral
         subjects affected / exposed
    6 / 36 (16.67%)
         occurrences all number
    9
    Dysgeusia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    5
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    6
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    8 / 36 (22.22%)
         occurrences all number
    9
    Pyrexia
         subjects affected / exposed
    10 / 36 (27.78%)
         occurrences all number
    13
    Asthenia
         subjects affected / exposed
    24 / 36 (66.67%)
         occurrences all number
    61
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 36 (16.67%)
         occurrences all number
    6
    Diarrhoea
         subjects affected / exposed
    29 / 36 (80.56%)
         occurrences all number
    68
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences all number
    8
    Abdominal pain
         subjects affected / exposed
    9 / 36 (25.00%)
         occurrences all number
    12
    Dyspepsia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    17 / 36 (47.22%)
         occurrences all number
    29
    Dysphagia
         subjects affected / exposed
    5 / 36 (13.89%)
         occurrences all number
    13
    Vomiting
         subjects affected / exposed
    15 / 36 (41.67%)
         occurrences all number
    26
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Nail disorder
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 36 (8.33%)
         occurrences all number
    5
    Pain in extremity
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    2 / 36 (5.56%)
         occurrences all number
    4
    Decreased appetite
         subjects affected / exposed
    15 / 36 (41.67%)
         occurrences all number
    30

    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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