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   43865   clinical trials with a EudraCT protocol, of which   7286   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 randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinumcontaining-chemotherapy

    Summary
    EudraCT number
    		 2016-004340-11
    Trial protocol
    		 GB   IE   NL   FR   AT   CZ   ES   PT   FI   SK   HU   DK   BE   SE   PL   IT  
    Global end of trial date
    27 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2021
    First version publication date
    30 Oct 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    17403
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03410693
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    31 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective for the Phase 2 part of the study was to demonstrate the efficacy of rogaratinib over chemotherapy (docetaxel, paclitaxel, or vinflunine) in terms of ORR of urothelial carcinoma patients with FGFR positive tumors. The original objective of the Phase 3 part of the study was to demonstrate the superiority of rogaratinib over chemotherapy in terms of prolonging the overall survival (OS) of urothelial carcinoma patients with FGFR positive tumors. Once the decision was made to not conduct the Phase 3 part of the study, OS was then considered an exploratory efficacy variable for Phase 2.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 9
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    China: 4
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Ireland: 6
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Japan: 14
    Country: Number of subjects enrolled
    Korea, Republic of: 15
    Country: Number of subjects enrolled
    Netherlands: 2
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Portugal: 5
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    Taiwan: 14
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    175
    EEA total number of subjects
    96
    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)
    55
    From 65 to 84 years
    119
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study enrolled participants at 111centers in 28 countries from 31 MAY 2018 (first participant first visit) to 27 OCT 2020 (last participant last visit).

    Pre-assignment
    Screening details
    		 A total of 718 participants signed the informed consent for prescreening, of which 256 participants completed the prescreening, while 462 participants discontinued the prescreening. The discontinuations were due to screening failure (322), other reasons (98), withdrawal by the participant (22), and death (20).

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rogaratinib (BAY1163877)_overall population
    Arm description
    		 Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rogaratinib
    Investigational medicinal product code
    BAY1163877
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rogaratinib 600 mg (consisting of 3 tablets à 200 mg) was taken orally (p.o.) twice a day (b.i.d.), continuously, during a 21-day treatment cycle.

    Arm title
    		 Chemotherapy_overall population
    Arm description
    		 Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The starting dose for docetaxel was 75 mg/m² given as i.v. infusion, once every three weeks (on day 1 of a 21-day cycle).

    Investigational medicinal product name
    Vinflunine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The starting dose for vinflunine was 320 mg/m² given as i.v. infusion, once every three weeks (on day 1 of a 21-day cycle).

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The starting dose for paclitaxel was 175 mg/m² given as i.v. infusion, once every three weeks (on day 1 of a 21-day cycle).

    Number of subjects in period 1
    		Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population
    Started
    87
    88
    Started treatment
    86
    82
    Active follow-up performed
    61
    56
    Entered long term follow-up
    56
    69
    Completed
    0
    0
    Not completed
    87
    88
         Disc trt: Lost to follow up
    -
    1
         Disc trt: Withdrawal by participant
    6
    4
         Disc trt: radiological progression
    58
    50
         Disc trt:AE not asso. w/ clinical disease progress
    1
    4
         Discontinued (disc) treatment (trt): Death
    6
    4
         Study drug never administered
    1
    6
         Disc trt: clinical progression
    1
    5
         Disc trt: Physician decision
    -
    5
         Disc trt: Adverse Event (AE)
    13
    9
         Disc trt: Other
    1
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Rogaratinib (BAY1163877)_overall population
    Reporting group description
    		 Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.

    Reporting group title
    Chemotherapy_overall population
    Reporting group description
    		 Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).

    Reporting group values
    		 Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population Total
    Number of subjects
    		 87 88 175
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 23 32 55
        From 65-84 years
    		 64 55 119
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.7 ( 8.3 ) 66.4 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 75 70 145
        Male
    		 12 18 30
    Race
    Units: Subjects
        White
    		 55 55 110
        Black or African American
    		 1 0 1
        Asian
    		 23 25 48
        Not reported
    		 8 8 16
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 76 78 154
        Hispanic or Latino
    		 1 0 1
        Not reported
    		 10 10 20
    Cancer Category
    Units: Subjects
        Location of primary cancer: bladder
    		 56 45 101
        Location of primary cancer: Ureter
    		 17 14 31
        Location of primary cancer: Renal pelvis
    		 12 28 40
        Location of primary cancer: Proximal urethra
    		 2 1 3
    Cancer stage at study entry
    Units: Subjects
        Stage III B
    		 1 3 4
        Stage IV
    		 5 12 17
        Stage IV A
    		 13 24 37
        Stage IV B
    		 67 48 115
        Unknown
    		 1 1 2
    PIK3CA and/or RAS activating mutations
    PIK3CA: Phosphoinositide 3 kinase, catalytic subunit alpha isoform RAS: Rat sarcoma
    Units: Subjects
        Absent
    		 65 69 134
        Present
    		 10 10 20
        Unknown
    		 12 9 21
    FGFR expression from Targos
    FGFR: Fibroblast growth factor receptor
    Units: Subjects
        Negative
    		 13 14 27
        Positive
    		 69 69 138
        Not assessed
    		 5 5 10

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Rogaratinib (BAY1163877)_overall population
    Reporting group description
    		 Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.

    Reporting group title
    Chemotherapy_overall population
    Reporting group description
    		 Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).

    Subject analysis set title
    Rogaratinib_WT population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Wild type population

    Subject analysis set title
    Chemotherapy_WT population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Wild type population

    Primary: Objective response rate (ORR) - central assessment

    		 Close Top of page
    End point title
    		 Objective response rate (ORR) - central assessment
    End point description
    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.
    End point type
    Primary
    End point timeframe
    From start of treatment up to end of active follow-up
    End point values
    		 Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population Rogaratinib_WT population Chemotherapy_WT population
    Number of subjects analysed
    87
    88
    62
    63
    Units: percentage
        number (confidence interval 95%)
    19.5 (11.8 to 29.4)
    21.6 (13.5 to 31.6)
    19.4 (10.4 to 31.4)
    23.8 (14.0 to 36.2)
    Statistical analysis title
    		 ORR difference_overall population
    Comparison groups
    Rogaratinib (BAY1163877)_overall population v Chemotherapy_overall population
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6991
    Method
    		 Fisher exact
    Parameter type
    		 ORR difference (R-C)
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 9.9
    Statistical analysis title
    		 ORR difference_WT Population
    Comparison groups
    Chemotherapy_WT population v Rogaratinib_WT population
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7944
    Method
    		 Fisher exact
    Parameter type
    		 ORR difference (R − C)
    Point estimate
    -4.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.9
         upper limit
    		 9.9

    Secondary: Disease-control rate (DCR) - central assessment

    		 Close Top of page
    End point title
    		 Disease-control rate (DCR) - central assessment
    End point description
    DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).
    End point type
    Secondary
    End point timeframe
    From start of treatment till end of active follow-up
    End point values
    		 Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population Rogaratinib_WT population Chemotherapy_WT population
    Number of subjects analysed
    87
    88
    62
    63
    Units: percentage
        number (confidence interval 95%)
    50.6 (39.6 to 61.5)
    55.7 (44.7 to 66.3)
    53.2 (40.1 to 66.0)
    63.5 (50.4 to 75.3)
    Statistical analysis title
    		 DCR difference_Overall Population
    Comparison groups
    Rogaratinib (BAY1163877)_overall population v Chemotherapy_overall population
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7962
    Method
    		 Fisher exact
    Parameter type
    		 DCR difference (R-C)
    Point estimate
    -5.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.9
         upper limit
    		 9.7
    Statistical analysis title
    		 DCR difference_WT population
    Comparison groups
    Rogaratinib_WT population v Chemotherapy_WT population
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9109
    Method
    		 Fisher exact
    Parameter type
    		 DCR difference (R-C)
    Point estimate
    -10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.5
         upper limit
    		 6.9

    Secondary: Progression-free survival (PFS) - central assessment

    		 Close Top of page
    End point title
    		 Progression-free survival (PFS) - central assessment
    End point description
    Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).
    End point type
    Secondary
    End point timeframe
    From start of treatment till end of active follow-up
    End point values
    		 Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population Rogaratinib_WT population Chemotherapy_WT population
    Number of subjects analysed
    87
    88
    62
    63
    Units: months
        median (confidence interval 95%)
    2.7 (1.6 to 4.6)
    3.2 (2.7 to 4.4)
    2.8 (2.6 to 5.1)
    4.0 (2.8 to 6.1)
    Statistical analysis title
    		 Hazard ratio (R/C)_Overall population
    Comparison groups
    Rogaratinib (BAY1163877)_overall population v Chemotherapy_overall population
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8672
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.226
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.853
         upper limit
    		 1.762
    Statistical analysis title
    		 Hazard ratio (R/C)_WT population
    Comparison groups
    Rogaratinib_WT population v Chemotherapy_WT population
    Number of subjects included in analysis
    125
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9171
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.341
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 2.043

    Secondary: Duration of response (DOR)- central assessment

    		 Close Top of page
    End point title
    		 Duration of response (DOR)- central assessment
    End point description
    DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier
    End point type
    Secondary
    End point timeframe
    From start of treatment till end of active follow-up
    End point values
    		 Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population Rogaratinib_WT population Chemotherapy_WT population
    Number of subjects analysed
    87
    88
    62
    63
    Units: months
        median (confidence interval 95%)
    4.9 (2.2 to 7.0)
    5.8 (3.5 to 7.7)
    5.1 (1.5 to 9.2)
    7.0 (2.7 to 8.4)
    No statistical analyses for this end point

    Secondary: Number of participants with treatment emergent adverse events

    		 Close Top of page
    End point title
    		 Number of participants with treatment emergent adverse events
    End point description
    A treatment-emergent event is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
    End point type
    Secondary
    End point timeframe
    From start of treatment up to 30 days after the last administration of study treatment
    End point values
    		 Rogaratinib (BAY1163877)_overall population Chemotherapy_overall population
    Number of subjects analysed
    86
    82
    Units: participants
        Any TEAE
    86
    82
        Any drug related TEAE
    81
    76
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the start of study drug administration until 30 days after the last administration of study treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Rogaratinib (BAY1163877)
    Reporting group description
    		 Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.

    Reporting group title
    Chemotherapy
    Reporting group description
    		 Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).

    Serious adverse events
    		 Rogaratinib (BAY1163877) Chemotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    39 / 86 (45.35%)
    33 / 82 (40.24%)
         number of deaths (all causes)
    47
    45
         number of deaths resulting from adverse events
    16
    5
    Surgical and medical procedures
    Ureteral stent insertion
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (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
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Condition aggravated
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Death
         subjects affected / exposed
    4 / 86 (4.65%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Mucosal inflammation
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (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
    1 / 86 (1.16%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 86 (4.65%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 86 (3.49%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy liver
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 86 (2.33%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    3 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neurotoxicity
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 86 (0.00%)
    4 / 82 (4.88%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 86 (0.00%)
    4 / 82 (4.88%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (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
    3 / 86 (3.49%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (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
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (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
    1 / 86 (1.16%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 86 (1.16%)
    3 / 82 (3.66%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 86 (1.16%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    3 / 86 (3.49%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 86 (0.00%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Relapsing fever
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 86 (0.00%)
    3 / 82 (3.66%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 86 (1.16%)
    4 / 82 (4.88%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 86 (1.16%)
    2 / 82 (2.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         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
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Device related infection
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 86 (1.16%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 86 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rogaratinib (BAY1163877) Chemotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    85 / 86 (98.84%)
    77 / 82 (93.90%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    6 / 86 (6.98%)
    1 / 82 (1.22%)
         occurrences all number
    6
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    25 / 86 (29.07%)
    19 / 82 (23.17%)
         occurrences all number
    52
    40
    Mucosal inflammation
         subjects affected / exposed
    7 / 86 (8.14%)
    8 / 82 (9.76%)
         occurrences all number
    20
    12
    Fatigue
         subjects affected / exposed
    21 / 86 (24.42%)
    28 / 82 (34.15%)
         occurrences all number
    32
    41
    Oedema peripheral
         subjects affected / exposed
    8 / 86 (9.30%)
    10 / 82 (12.20%)
         occurrences all number
    9
    13
    Pyrexia
         subjects affected / exposed
    12 / 86 (13.95%)
    10 / 82 (12.20%)
         occurrences all number
    15
    14
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 86 (4.65%)
    6 / 82 (7.32%)
         occurrences all number
    6
    7
    Dyspnoea
         subjects affected / exposed
    3 / 86 (3.49%)
    5 / 82 (6.10%)
         occurrences all number
    3
    6
    Epistaxis
         subjects affected / exposed
    10 / 86 (11.63%)
    1 / 82 (1.22%)
         occurrences all number
    10
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    5 / 86 (5.81%)
    4 / 82 (4.88%)
         occurrences all number
    5
    4
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    13 / 86 (15.12%)
    2 / 82 (2.44%)
         occurrences all number
    22
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    10 / 86 (11.63%)
    2 / 82 (2.44%)
         occurrences all number
    16
    3
    Blood creatinine increased
         subjects affected / exposed
    11 / 86 (12.79%)
    3 / 82 (3.66%)
         occurrences all number
    18
    6
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 86 (5.81%)
    0 / 82 (0.00%)
         occurrences all number
    6
    0
    Lipase increased
         subjects affected / exposed
    9 / 86 (10.47%)
    3 / 82 (3.66%)
         occurrences all number
    25
    11
    Neutrophil count decreased
         subjects affected / exposed
    0 / 86 (0.00%)
    14 / 82 (17.07%)
         occurrences all number
    0
    22
    Weight decreased
         subjects affected / exposed
    10 / 86 (11.63%)
    6 / 82 (7.32%)
         occurrences all number
    11
    7
    White blood cell count decreased
         subjects affected / exposed
    0 / 86 (0.00%)
    5 / 82 (6.10%)
         occurrences all number
    0
    5
    Blood alkaline phosphatase increased
         subjects affected / exposed
    12 / 86 (13.95%)
    2 / 82 (2.44%)
         occurrences all number
    14
    3
    Calcium phosphate product increased
         subjects affected / exposed
    8 / 86 (9.30%)
    0 / 82 (0.00%)
         occurrences all number
    10
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    13 / 86 (15.12%)
    5 / 82 (6.10%)
         occurrences all number
    14
    6
    Headache
         subjects affected / exposed
    6 / 86 (6.98%)
    4 / 82 (4.88%)
         occurrences all number
    7
    5
    Neuropathy peripheral
         subjects affected / exposed
    3 / 86 (3.49%)
    10 / 82 (12.20%)
         occurrences all number
    4
    12
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 86 (1.16%)
    10 / 82 (12.20%)
         occurrences all number
    1
    14
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 86 (3.49%)
    19 / 82 (23.17%)
         occurrences all number
    6
    30
    Anaemia
         subjects affected / exposed
    11 / 86 (12.79%)
    28 / 82 (34.15%)
         occurrences all number
    17
    66
    Eye disorders
    Dry eye
         subjects affected / exposed
    5 / 86 (5.81%)
    3 / 82 (3.66%)
         occurrences all number
    5
    3
    Detachment of retinal pigment epithelium
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 82 (0.00%)
         occurrences all number
    16
    0
    Subretinal fluid
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 82 (0.00%)
         occurrences all number
    8
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    15 / 86 (17.44%)
    13 / 82 (15.85%)
         occurrences all number
    18
    27
    Constipation
         subjects affected / exposed
    25 / 86 (29.07%)
    29 / 82 (35.37%)
         occurrences all number
    31
    54
    Diarrhoea
         subjects affected / exposed
    48 / 86 (55.81%)
    18 / 82 (21.95%)
         occurrences all number
    92
    19
    Dry mouth
         subjects affected / exposed
    10 / 86 (11.63%)
    2 / 82 (2.44%)
         occurrences all number
    15
    2
    Mouth ulceration
         subjects affected / exposed
    5 / 86 (5.81%)
    3 / 82 (3.66%)
         occurrences all number
    7
    3
    Nausea
         subjects affected / exposed
    27 / 86 (31.40%)
    20 / 82 (24.39%)
         occurrences all number
    38
    38
    Vomiting
         subjects affected / exposed
    15 / 86 (17.44%)
    18 / 82 (21.95%)
         occurrences all number
    19
    26
    Stomatitis
         subjects affected / exposed
    10 / 86 (11.63%)
    10 / 82 (12.20%)
         occurrences all number
    15
    14
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    20 / 86 (23.26%)
    24 / 82 (29.27%)
         occurrences all number
    23
    26
    Dry skin
         subjects affected / exposed
    7 / 86 (8.14%)
    2 / 82 (2.44%)
         occurrences all number
    9
    2
    Nail discolouration
         subjects affected / exposed
    6 / 86 (6.98%)
    0 / 82 (0.00%)
         occurrences all number
    8
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 82 (0.00%)
         occurrences all number
    10
    0
    Rash
         subjects affected / exposed
    7 / 86 (8.14%)
    3 / 82 (3.66%)
         occurrences all number
    9
    5
    Onychomadesis
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 82 (0.00%)
         occurrences all number
    8
    0
    Nail toxicity
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 82 (0.00%)
         occurrences all number
    12
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    9 / 86 (10.47%)
    6 / 82 (7.32%)
         occurrences all number
    13
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 86 (10.47%)
    7 / 82 (8.54%)
         occurrences all number
    12
    7
    Back pain
         subjects affected / exposed
    8 / 86 (9.30%)
    8 / 82 (9.76%)
         occurrences all number
    8
    9
    Myalgia
         subjects affected / exposed
    5 / 86 (5.81%)
    10 / 82 (12.20%)
         occurrences all number
    6
    12
    Pain in extremity
         subjects affected / exposed
    7 / 86 (8.14%)
    4 / 82 (4.88%)
         occurrences all number
    10
    4
    Infections and infestations
    Influenza
         subjects affected / exposed
    5 / 86 (5.81%)
    0 / 82 (0.00%)
         occurrences all number
    5
    0
    Conjunctivitis
         subjects affected / exposed
    5 / 86 (5.81%)
    3 / 82 (3.66%)
         occurrences all number
    8
    3
    Paronychia
         subjects affected / exposed
    7 / 86 (8.14%)
    0 / 82 (0.00%)
         occurrences all number
    8
    0
    Urinary tract infection
         subjects affected / exposed
    12 / 86 (13.95%)
    8 / 82 (9.76%)
         occurrences all number
    12
    13
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    8 / 86 (9.30%)
    6 / 82 (7.32%)
         occurrences all number
    11
    14
    Hyperphosphataemia
         subjects affected / exposed
    39 / 86 (45.35%)
    0 / 82 (0.00%)
         occurrences all number
    79
    0
    Hyponatraemia
         subjects affected / exposed
    6 / 86 (6.98%)
    5 / 82 (6.10%)
         occurrences all number
    9
    7
    Decreased appetite
         subjects affected / exposed
    36 / 86 (41.86%)
    21 / 82 (25.61%)
         occurrences all number
    55
    25

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2019
    • The maximum planned dose was reduced to 600 mg BID from 800 mg BID; • The requirement of cytological confirmation of urothelial carcinoma was removed from the inclusion criteria; • A roll over study was introduced; • Post dose 12 lead ECG beyond cycle 5 was removed.
    12 Nov 2019
    • Clarifications were added to explain that due to the stop of enrollment, the study was not to move forward to its Phase 3 and remain Phase 2; • The primary efficacy variable was updated as ORR for the Phase 2 part, and OS was considered an exploratory efficacy variable for the Phase 2 part; • A post trial access program was added as an option for patients to continue receiving rogaratinib treatment and LPLV to be reached based on the last patient changing to a post trial access program.

    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-Sat Apr 27 00:35:56 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA