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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 Highly Emetogenic Chemotherapy (HEC)

    Summary
    EudraCT number
    		 2010-022743-37
    Trial protocol
    		 HU   ES   CZ   PL   SK   IT  
    Global end of trial date
    24 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

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    Trial identification
    Sponsor protocol code
    TS-P04833
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01500213
    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
    04 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 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 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
    Poland: 79
    Country: Number of subjects enrolled
    Slovakia: 3
    Country: Number of subjects enrolled
    Spain: 71
    Country: Number of subjects enrolled
    Czech Republic: 24
    Country: Number of subjects enrolled
    Hungary: 37
    Country: Number of subjects enrolled
    Italy: 43
    Country: Number of subjects enrolled
    Brazil: 70
    Country: Number of subjects enrolled
    Georgia: 63
    Country: Number of subjects enrolled
    Korea, Republic of: 69
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    Ukraine: 18
    Country: Number of subjects enrolled
    United States: 36
    Country: Number of subjects enrolled
    South Africa: 17
    Worldwide total number of subjects
    544
    EEA total number of subjects
    257
    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)
    398
    From 65 to 84 years
    146
    85 years and over
    0

    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 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
    		 MITT population: 278 participants were randomized to Rolapitant and 277 were randomized to control, 272 of those randomized to Rolapitant received study drug in C1; 274 of those who were randomized to control received study drug in C1, 1 Rolapitant subject and 1 control subject were from GCP-non-compliant sites.

    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
    271
    273
    Completed
    60
    53
    Not completed
    211
    220
         Consent withdrawn by subject
    26
    35
         Physician decision
    12
    10
         Adverse event, non-fatal
    35
    34
         Other Reasons
    6
    5
         Death
    7
    3
         Chemo Completed or Change in Therapy
    84
    81
         Lost to follow-up
    3
    6
         Disease Progression
    13
    21
         Lack of efficacy
    9
    7
         Protocol deviation
    16
    18

    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 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
    		 271 273 544
    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)
    		 58.5 ± 10.05 58.5 ± 9.25 -
    Gender categorical
    Units: Subjects
        Female
    		 88 87 175
        Male
    		 183 186 369
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 36 38 74
        Not Hispanic or Latino
    		 235 235 470
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 8 10
        Asian
    		 34 41 75
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 2 3 5
        White
    		 226 212 438
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 7 9 16

    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 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

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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 HEC. 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
    271 [1]
    273 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    70.1 (64.3 to 75.5)
    61.9 (55.9 to 67.7)
    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
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.043 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 2.1
    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
    271 [4]
    273 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    83.4 (78.4 to 87.6)
    79.5 (74.2 to 84.1)
    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
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.233 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 2
    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
    271 [7]
    273 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    67.5 (61.6 to 73.1)
    60.4 (54.4 to 66.3)
    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
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.084 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.9
    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 (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
    80 / 272 (29.41%)
    65 / 274 (23.72%)
         number of deaths (all causes)
    12
    11
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukoerythroblastosis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oral neoplasm
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tumour pain
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial occlusive disease
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Axillary vein thrombosis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 272 (1.10%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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
    3 / 272 (1.10%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 272 (0.37%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 272 (1.84%)
    5 / 274 (1.82%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Disease progression
         subjects affected / exposed
    3 / 272 (1.10%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Fatigue
         subjects affected / exposed
    2 / 272 (0.74%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 272 (0.74%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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 / 272 (0.37%)
    0 / 274 (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
    Drug hypersensitivity
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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 pulmonary oedema
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 272 (0.74%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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
    1 / 272 (0.37%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    3 / 272 (1.10%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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
    0 / 272 (0.00%)
    4 / 274 (1.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Toxicity to various agents
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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
    Anaemia
         subjects affected / exposed
    4 / 272 (1.47%)
    3 / 274 (1.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    12 / 272 (4.41%)
    6 / 274 (2.19%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    5 / 272 (1.84%)
    7 / 274 (2.55%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 272 (0.37%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 272 (1.47%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 272 (1.47%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphagia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haematochezia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    2 / 272 (0.74%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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
    2 / 272 (0.74%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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
    Dysuria
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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
    2 / 272 (0.74%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 272 (0.00%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis Herpes
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Influenza
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (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
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 272 (0.37%)
    6 / 274 (2.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 272 (1.10%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 272 (0.00%)
    3 / 274 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    3 / 272 (1.10%)
    2 / 274 (0.73%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 272 (0.37%)
    0 / 274 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 272 (0.00%)
    1 / 274 (0.36%)
         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
    225 / 272 (82.72%)
    211 / 274 (77.01%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 272 (5.51%)
    12 / 274 (4.38%)
         occurrences all number
    17
    16
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    30 / 272 (11.03%)
    16 / 274 (5.84%)
         occurrences all number
    42
    28
    Neutropenia
         subjects affected / exposed
    39 / 272 (14.34%)
    32 / 274 (11.68%)
         occurrences all number
    60
    45
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    52 / 272 (19.12%)
    55 / 274 (20.07%)
         occurrences all number
    89
    83
    Fatigue
         subjects affected / exposed
    21 / 272 (7.72%)
    28 / 274 (10.22%)
         occurrences all number
    26
    32
    Mucosal inflammation
         subjects affected / exposed
    21 / 272 (7.72%)
    21 / 274 (7.66%)
         occurrences all number
    29
    27
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    14 / 272 (5.15%)
    9 / 274 (3.28%)
         occurrences all number
    19
    9
    Constipation
         subjects affected / exposed
    37 / 272 (13.60%)
    40 / 274 (14.60%)
         occurrences all number
    47
    47
    Diarrhoea
         subjects affected / exposed
    34 / 272 (12.50%)
    28 / 274 (10.22%)
         occurrences all number
    48
    40
    Dyspepsia
         subjects affected / exposed
    10 / 272 (3.68%)
    14 / 274 (5.11%)
         occurrences all number
    12
    16
    Nausea
         subjects affected / exposed
    32 / 272 (11.76%)
    35 / 274 (12.77%)
         occurrences all number
    52
    61
    Vomiting
         subjects affected / exposed
    14 / 272 (5.15%)
    23 / 274 (8.39%)
         occurrences all number
    24
    34
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 272 (4.04%)
    14 / 274 (5.11%)
         occurrences all number
    11
    16
    Hiccups
         subjects affected / exposed
    25 / 272 (9.19%)
    12 / 274 (4.38%)
         occurrences all number
    35
    17
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    20 / 272 (7.35%)
    26 / 274 (9.49%)
         occurrences all number
    23
    29
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 272 (2.57%)
    15 / 274 (5.47%)
         occurrences all number
    9
    18
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    39 / 272 (14.34%)
    35 / 274 (12.77%)
         occurrences all number
    54
    47
    Hypomagnesaemia
         subjects affected / exposed
    16 / 272 (5.88%)
    16 / 274 (5.84%)
         occurrences all number
    24
    25

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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