Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    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 Highly Emetogenic Chemotherapy (HEC)

    Summary
    EudraCT number
    		 2010-022742-25
    Trial protocol
    		 LV   BE   PT   BG   ES   IT   HU  
    Global end of trial date
    03 May 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-P04832
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01499849
    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, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, Tesaro, 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
    11 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 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 HEC. 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
    07 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
    Canada: 16
    Country: Number of subjects enrolled
    Mexico: 8
    Country: Number of subjects enrolled
    Peru: 46
    Country: Number of subjects enrolled
    Russian Federation: 81
    Country: Number of subjects enrolled
    Thailand: 116
    Country: Number of subjects enrolled
    United States: 71
    Country: Number of subjects enrolled
    Belarus: 17
    Country: Number of subjects enrolled
    Guatemala: 2
    Country: Number of subjects enrolled
    Romania: 21
    Country: Number of subjects enrolled
    Portugal: 14
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Bulgaria: 39
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Latvia: 9
    Worldwide total number of subjects
    526
    EEA total number of subjects
    169
    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)
    392
    From 65 to 84 years
    132
    85 years and over
    2

    Subject disposition

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

    Pre-assignment
    Screening details
    		 Overall Number of Baseline Participants only included the Modified Intent to Treat (MITT) population: 266 subjects were randomized to Rolapitant and 266 were randomized to control; 264 of those randomized to Rolapitant received study drug in Cycle 1; 262 of those who were randomized to control received study drug in Cycle 1.

    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 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy * Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4
    Arm type
    		 Experimental

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

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy

    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, and dexamethasone 8 mg orally twice daily on days 2–4

    Arm title
    		 Placebo + Granisetron + Dexamethasone
    Arm description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4
    Arm type
    		 Active comparator

    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
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy

    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, and dexamethasone 8 mg orally twice daily on days 2–4

    Number of subjects in period 1
    		Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Started
    264
    262
    Completed
    42
    40
    Not completed
    222
    222
         Consent withdrawn by subject
    43
    42
         Physician decision
    20
    19
         Adverse event, non-fatal
    27
    30
         Other Reasons
    26
    29
         Death
    5
    7
         Lost to follow-up
    6
    3
         Chemo completed or Change in Therapy
    70
    67
         Disease Progression
    11
    10
         Protocol deviation
    11
    11
         Lack of efficacy
    3
    4

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics 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 (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4

    Reporting group title
    Placebo + Granisetron + Dexamethasone
    Reporting group description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4

    Reporting group values
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone Total
    Number of subjects
    		 264 262 526
    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)
    		 57.0 ( 10.08 ) 57.7 ( 11.15 ) -
    Gender categorical
    Units: Subjects
        Female
    		 110 112 222
        Male
    		 154 150 304
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 33 34 67
        Not Hispanic or Latino
    		 231 228 459
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 0 2
        Asian
    		 61 56 117
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 3 5
        White
    		 178 179 357
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 21 24 45

    End points

    		 Close Top of page
    End points 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 (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4

    Reporting group title
    Placebo + Granisetron + Dexamethasone
    Reporting group description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4

    Primary: No Emetic Episodes and No Rescue Medication

    		 Close Top of page
    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 HEC. 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).
    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
    264 [1]
    262 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    72.7 (66.9 to 78.0)
    58.4 (52.2 to 64.4)
    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
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 2.7
    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

    		 Close Top of page
    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
    264 [4]
    262 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    83.7 (78.7 to 88.0)
    73.7 (67.9 to 78.9)
    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
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 2.8
    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

    		 Close Top of page
    End point title
    		 Overall Response Rate
    End point description
    To determine the effect of rolapitant on complete response rates 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
    264 [7]
    262 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    70.1 (64.2 to 75.5)
    56.5 (50.2 to 62.6)
    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
    526
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 2.6
    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

    		 Close Top of page
    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.
    Adverse event reporting additional description
    Safety analysis was based on actual treatment received in Cycle 1. 266 subjects were randomized to Rolapitant, among which 263 received Rolapitant in Cycle 1, hence Safety=263 for Rolapitant. 266 subjects were randomized to control, among which 263 received control in Cycle 1 (There was an error in treatment received), hence Safety=263 for control.
    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 (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4

    Reporting group title
    Placebo + Granisetron + Dexamethasone
    Reporting group description
    		 * Matching placebo 1–2 h before administration of chemotherapy * Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy * Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4

    Serious adverse events
    		 Rolapitant + Granisetron + Dexamethasone Placebo + Granisetron + Dexamethasone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 263 (14.07%)
    54 / 263 (20.53%)
         number of deaths (all causes)
    10
    16
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bronchial carcinoma
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal Stromal Cancer
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypotension
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         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
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 263 (0.00%)
    3 / 263 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Disease progression
         subjects affected / exposed
    1 / 263 (0.38%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Fatigue
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 263 (0.38%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    0 / 263 (0.00%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         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
    Acute respiratory failure
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchopleural fistula
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydropneumothorax
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         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
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         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
    2 / 263 (0.76%)
    4 / 263 (1.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 263 (0.76%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 263 (0.76%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 263 (0.38%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 263 (0.38%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    3 / 263 (1.14%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 263 (0.00%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         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 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 263 (0.38%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (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 / 263 (0.00%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 263 (0.00%)
    5 / 263 (1.90%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure Acute
         subjects affected / exposed
    2 / 263 (0.76%)
    3 / 263 (1.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Hypercreatinaemia
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis Herpes
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (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
    5 / 263 (1.90%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 263 (0.00%)
    2 / 263 (0.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (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
    2 / 263 (0.76%)
    5 / 263 (1.90%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetes mellitus
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 263 (0.00%)
    1 / 263 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 263 (0.38%)
    0 / 263 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         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
    187 / 263 (71.10%)
    198 / 263 (75.29%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    28 / 263 (10.65%)
    32 / 263 (12.17%)
         occurrences all number
    53
    55
    Leukopenia
         subjects affected / exposed
    18 / 263 (6.84%)
    14 / 263 (5.32%)
         occurrences all number
    68
    48
    Neutropenia
         subjects affected / exposed
    33 / 263 (12.55%)
    23 / 263 (8.75%)
         occurrences all number
    93
    71
    Thrombocytopenia
         subjects affected / exposed
    16 / 263 (6.08%)
    12 / 263 (4.56%)
         occurrences all number
    24
    40
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    35 / 263 (13.31%)
    40 / 263 (15.21%)
         occurrences all number
    58
    54
    Fatigue
         subjects affected / exposed
    36 / 263 (13.69%)
    30 / 263 (11.41%)
         occurrences all number
    52
    40
    Mucosal inflammation
         subjects affected / exposed
    17 / 263 (6.46%)
    19 / 263 (7.22%)
         occurrences all number
    20
    22
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    26 / 263 (9.89%)
    29 / 263 (11.03%)
         occurrences all number
    31
    31
    Diarrhoea
         subjects affected / exposed
    20 / 263 (7.60%)
    18 / 263 (6.84%)
         occurrences all number
    24
    20
    Dyspepsia
         subjects affected / exposed
    18 / 263 (6.84%)
    8 / 263 (3.04%)
         occurrences all number
    24
    10
    Nausea
         subjects affected / exposed
    24 / 263 (9.13%)
    35 / 263 (13.31%)
         occurrences all number
    29
    48
    Stomatitis
         subjects affected / exposed
    16 / 263 (6.08%)
    14 / 263 (5.32%)
         occurrences all number
    21
    15
    Vomiting
         subjects affected / exposed
    9 / 263 (3.42%)
    22 / 263 (8.37%)
         occurrences all number
    10
    25
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    16 / 263 (6.08%)
    8 / 263 (3.04%)
         occurrences all number
    20
    12
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    22 / 263 (8.37%)
    23 / 263 (8.75%)
         occurrences all number
    24
    26
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    30 / 263 (11.41%)
    36 / 263 (13.69%)
         occurrences all number
    30
    44
    Dehydration
         subjects affected / exposed
    13 / 263 (4.94%)
    15 / 263 (5.70%)
         occurrences all number
    15
    15

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 11:44:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA