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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy (MEC)

    Summary
    EudraCT number
    		 2010-022746-24
    Trial protocol
    		 HU   LV   ES   BE   CZ   PL   BG   SK   PT   IT  
    Global end of trial date
    19 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Dec 2019
    First version publication date
    27 Dec 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TS-P04834
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01500226
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tesaro
    Sponsor organisation address
    1000 Winter St North, Waltham, United States, 02451
    Public contact
    GSK Response Center, Tesaro, 1866 4357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, Tesaro, 1866 4357343, GSKClinicalSupportHD@gsk.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
    30 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Feb 2012
    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
    Poland: 26
    Country: Number of subjects enrolled
    Portugal: 4
    Country: Number of subjects enrolled
    Slovakia: 7
    Country: Number of subjects enrolled
    Spain: 80
    Country: Number of subjects enrolled
    Belgium: 24
    Country: Number of subjects enrolled
    Bulgaria: 57
    Country: Number of subjects enrolled
    Czech Republic: 25
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Hungary: 89
    Country: Number of subjects enrolled
    Italy: 38
    Country: Number of subjects enrolled
    Latvia: 20
    Country: Number of subjects enrolled
    Belarus: 24
    Country: Number of subjects enrolled
    Georgia: 67
    Country: Number of subjects enrolled
    Korea, Republic of: 45
    Country: Number of subjects enrolled
    Mexico: 15
    Country: Number of subjects enrolled
    Peru: 48
    Country: Number of subjects enrolled
    Romania: 60
    Country: Number of subjects enrolled
    Russian Federation: 76
    Country: Number of subjects enrolled
    Thailand: 76
    Country: Number of subjects enrolled
    Taiwan: 45
    Country: Number of subjects enrolled
    Ukraine: 9
    Country: Number of subjects enrolled
    United States: 445
    Country: Number of subjects enrolled
    South Africa: 47
    Worldwide total number of subjects
    1332
    EEA total number of subjects
    435
    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)
    965
    From 65 to 84 years
    364
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.

    Pre-assignment
    Screening details
    		 684 subjects were randomized to Rolapitant and 685 were randomized to control; 670 of those randomized to Rolapitant received study drug in C1; 674 of those who were randomized to control received study drug in C1. 4 Rolapitant subject and 8 control subject were from GCP-non-compliant sites. MITT = 666 Rolapitant and 666 control

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rolapitant + Granisetron + Dexamethasone
    Arm description
    		 * Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy. * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rolapitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy.

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone (20 mg orally) about 30 min before chemotherapy.

    Arm title
    		 Placebo + Granisetron + Dexamethasone
    Arm description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching Placebo for Rolapitant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo 1–2 h before administration of chemotherapy

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone (20 mg orally) about 30 min before chemotherapy.

    Number of subjects in period 1
    		Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Started
    666
    666
    Completed
    185
    189
    Not completed
    481
    477
         Consent withdrawn by subject
    87
    89
         Physician decision
    17
    15
         Other Reasons
    15
    15
         Adverse event, non-fatal
    31
    38
         Death
    12
    4
         Chemo Completed or Change in Therapy
    235
    232
         Lost to follow-up
    9
    5
         Disease Progression
    16
    14
         Protocol deviation
    45
    35
         Lack of efficacy
    14
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rolapitant + Granisetron + Dexamethasone
    Reporting group description
    		 * Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy. * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy.

    Reporting group title
    Placebo + Granisetron + Dexamethasone
    Reporting group description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy

    Reporting group values
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone Total
    Number of subjects
    		 666 666 1332
    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)
    		 56.7 ± 11.65 56.6 ± 12.01 -
    Gender categorical
    Units: Subjects
        Female
    		 531 536 1067
        Male
    		 135 130 265
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 77 70 147
        Not Hispanic or Latino
    		 584 593 1177
        Unknown or Not Reported
    		 5 3 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 7 6 13
        Asian
    		 92 84 176
        Native Hawaiian or Other Pacific Islander
    		 1 2 3
        Black or African American
    		 24 29 53
        White
    		 508 512 1020
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 34 33 67

    End points

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    End points reporting groups
    Reporting group title
    Rolapitant + Granisetron + Dexamethasone
    Reporting group description
    		 * Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy. * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy.

    Reporting group title
    Placebo + Granisetron + Dexamethasone
    Reporting group description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy

    Primary: No Emetic Episodes and No Rescue Medication

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    End point title
    		 No Emetic Episodes and No Rescue Medication
    End point description
    The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).
    End point type
    Primary
    End point timeframe
    >24 to 120 hours post chemotherapy
    End point values
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Number of subjects analysed
    666 [1]
    666 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    71.3 (67.7 to 74.7)
    61.6 (57.7 to 65.3)
    Notes
    [1] - MITT Population
    [2] - MITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.
    Comparison groups
    Rolapitant + Granisetron + Dexamethasone v Placebo + Granisetron + Dexamethasone
    Number of subjects included in analysis
    1332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 2
    Notes
    [3] - To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.

    Secondary: Acute Phase Response

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    End point title
    		 Acute Phase Response
    End point description
    To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.
    End point type
    Secondary
    End point timeframe
    0 to 24 hours
    End point values
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Number of subjects analysed
    666 [4]
    666 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    83.5 (80.4 to 86.2)
    80.3 (77.1 to 83.3)
    Notes
    [4] - MITT Population
    [5] - MITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.
    Comparison groups
    Rolapitant + Granisetron + Dexamethasone v Placebo + Granisetron + Dexamethasone
    Number of subjects included in analysis
    1332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.143 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.6
    Notes
    [6] - To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.

    Secondary: Overall Response Rate

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    End point title
    		 Overall Response Rate
    End point description
    To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.
    End point type
    Secondary
    End point timeframe
    0 to 120 hours
    End point values
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Number of subjects analysed
    666 [7]
    666 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    68.6 (64.9 to 72.1)
    57.8 (54.0 to 61.6)
    Notes
    [7] - MITT Population
    [8] - MITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.
    Comparison groups
    Rolapitant + Granisetron + Dexamethasone v Placebo + Granisetron + Dexamethasone
    Number of subjects included in analysis
    1332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 2
    Notes
    [9] - To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 6 cycles of treatment. Median number cycles=2; each cycle median duration = 21-22days. AEs that occur up to 30 days past last dose of treatment are included. Number of deaths (all causes) include those occurring > 30 days after last dose treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Rolapitant + Granisetron + Dexamethasone
    Reporting group description
    		 * Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy 684 subjects were randomized to Rolapitant 670 of those randomized to Rolapitant received rolapitant in C1 Safety = 670 Rolapitant

    Reporting group title
    Placebo + Granisetron + Dexamethasone
    Reporting group description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3 * Dexamethasone (20 mg orally) about 30 min before chemotherapy 685 subjects were randomized to control 674 of those who were randomized to control received control in C1 Safety = 674 control

    Serious adverse events
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    89 / 670 (13.28%)
    103 / 674 (15.28%)
         number of deaths (all causes)
    16
    8
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm progression
         subjects affected / exposed
    1 / 670 (0.15%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 670 (0.45%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 670 (0.15%)
    3 / 674 (0.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         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
    Asthenia
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 670 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    4 / 670 (0.60%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 670 (0.00%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 670 (0.15%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (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
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    5 / 670 (0.75%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    3 / 670 (0.45%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 670 (0.30%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    3 / 670 (0.45%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 670 (0.00%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 670 (0.30%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 670 (0.30%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Headache
         subjects affected / exposed
    2 / 670 (0.30%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 670 (0.30%)
    5 / 674 (0.74%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    14 / 670 (2.09%)
    25 / 674 (3.71%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 670 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    7 / 670 (1.04%)
    13 / 674 (1.93%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 670 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 670 (0.30%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 670 (0.45%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jejunal perforation
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (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 / 670 (0.00%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 670 (0.00%)
    3 / 674 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Skin and subcutaneous tissue disorders
    Skin erosion
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    1 / 670 (0.15%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal Failure Chronic
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 670 (0.30%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 670 (0.30%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastroenteritis
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mucosal infection
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    4 / 670 (0.60%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Oral fungal infection
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic infection
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peridiverticular Abscess
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 670 (0.60%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 670 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 670 (0.60%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 670 (0.15%)
    1 / 674 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 670 (0.30%)
    2 / 674 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    6 / 670 (0.90%)
    4 / 674 (0.59%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 670 (0.15%)
    0 / 674 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 670 (0.00%)
    1 / 674 (0.15%)
         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: 5%
    Non-serious adverse events
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    540 / 670 (80.60%)
    542 / 674 (80.42%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    69 / 670 (10.30%)
    71 / 674 (10.53%)
         occurrences all number
    83
    86
    Dysgeusia
         subjects affected / exposed
    29 / 670 (4.33%)
    38 / 674 (5.64%)
         occurrences all number
    31
    39
    Headache
         subjects affected / exposed
    82 / 670 (12.24%)
    109 / 674 (16.17%)
         occurrences all number
    99
    132
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    67 / 670 (10.00%)
    50 / 674 (7.42%)
         occurrences all number
    110
    88
    Leukopenia
         subjects affected / exposed
    37 / 670 (5.52%)
    31 / 674 (4.60%)
         occurrences all number
    68
    93
    Neutropenia
         subjects affected / exposed
    96 / 670 (14.33%)
    84 / 674 (12.46%)
         occurrences all number
    178
    168
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    78 / 670 (11.64%)
    78 / 674 (11.57%)
         occurrences all number
    97
    104
    Fatigue
         subjects affected / exposed
    179 / 670 (26.72%)
    183 / 674 (27.15%)
         occurrences all number
    294
    259
    Mucosal inflammation
         subjects affected / exposed
    41 / 670 (6.12%)
    30 / 674 (4.45%)
         occurrences all number
    54
    36
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    34 / 670 (5.07%)
    31 / 674 (4.60%)
         occurrences all number
    41
    37
    Constipation
         subjects affected / exposed
    114 / 670 (17.01%)
    138 / 674 (20.47%)
         occurrences all number
    142
    167
    Diarrhoea
         subjects affected / exposed
    92 / 670 (13.73%)
    101 / 674 (14.99%)
         occurrences all number
    123
    131
    Dyspepsia
         subjects affected / exposed
    46 / 670 (6.87%)
    42 / 674 (6.23%)
         occurrences all number
    50
    50
    Nausea
         subjects affected / exposed
    76 / 670 (11.34%)
    97 / 674 (14.39%)
         occurrences all number
    101
    137
    Stomatitis
         subjects affected / exposed
    40 / 670 (5.97%)
    46 / 674 (6.82%)
         occurrences all number
    50
    57
    Vomiting
         subjects affected / exposed
    14 / 670 (2.09%)
    39 / 674 (5.79%)
         occurrences all number
    14
    48
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    35 / 670 (5.22%)
    37 / 674 (5.49%)
         occurrences all number
    39
    46
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    157 / 670 (23.43%)
    172 / 674 (25.52%)
         occurrences all number
    170
    185
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    32 / 670 (4.78%)
    55 / 674 (8.16%)
         occurrences all number
    37
    59
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    42 / 670 (6.27%)
    40 / 674 (5.93%)
         occurrences all number
    57
    68
    Arthralgia
         subjects affected / exposed
    25 / 670 (3.73%)
    34 / 674 (5.04%)
         occurrences all number
    30
    39
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    57 / 670 (8.51%)
    45 / 674 (6.68%)
         occurrences all number
    63
    58
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    92 / 670 (13.73%)
    87 / 674 (12.91%)
         occurrences all number
    116
    106
    Dehydration
         subjects affected / exposed
    25 / 670 (3.73%)
    37 / 674 (5.49%)
         occurrences all number
    26
    46
    Hypomagnesaemia
         subjects affected / exposed
    41 / 670 (6.12%)
    28 / 674 (4.15%)
         occurrences all number
    54
    36

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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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