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    Clinical Trial Results:
    A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

    Summary
    EudraCT number
    		 2018-004768-69
    Trial protocol
    		 DK   GB   DE   IT  
    Global end of trial date
    29 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Mar 2023
    First version publication date
    04 Mar 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCB 54828-207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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
    29 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating fibroblast growth factor receptor (FGFR) mutations or translocations.
    Protection of trial subjects
    This study was to be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was being conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 2019
    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
    Denmark: 6
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Japan: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 4
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    United States: 32
    Worldwide total number of subjects
    111
    EEA total number of subjects
    49
    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)
    66
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study enrolled participants at 49 study sites in the United States, South Korea, United Kingdom, France, Italy, Israel, Germany, Spain, Denmark, and Japan.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements
    Arm description
    		 Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pemigatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.5-, 9-, and 13.5-mg tablets; starting dose of 13.5 mg

    Arm title
    		 Cohort B: known or likely activating FGFR1-3 mutations
    Arm description
    		 Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pemigatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.5-, 9-, and 13.5-mg tablets; starting dose of 13.5 mg

    Arm title
    		 Cohort C: other FGFR mutations or arrangements
    Arm description
    		 Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pemigatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.5-, 9-, and 13.5-mg tablets; starting dose of 13.5 mg

    Arm title
    		 Other
    Arm description
    		 Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pemigatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.5-, 9-, and 13.5-mg tablets; starting dose of 13.5 mg

    Number of subjects in period 1
    		Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Started
    49
    32
    26
    4
    Completed
    0
    0
    0
    0
    Not completed
    49
    32
    26
    4
         Adverse event, serious fatal
    18
    17
    12
    4
         Consent withdrawn by subject
    4
    -
    3
    -
         Never Returned to Hospital
    -
    -
    1
    -
         Study Terminated by Sponsor
    25
    11
    6
    -
         Lost to follow-up
    1
    2
    3
    -
         Disease Progression
    1
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements
    Reporting group description
    		 Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Cohort B: known or likely activating FGFR1-3 mutations
    Reporting group description
    		 Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Cohort C: other FGFR mutations or arrangements
    Reporting group description
    		 Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Other
    Reporting group description
    		 Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other Total
    Number of subjects
    		 49 32 26 4 111
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 34 12 17 3 66
        From 65-84 years
    		 15 20 9 1 45
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.4 ± 11.51 66.0 ± 10.04 61.5 ± 13.32 48.0 ± 14.45 -
    Sex: Female, Male
    Units: participants
        Female
    		 28 19 14 1 62
        Male
    		 21 13 12 3 49
    Race, Customized
    Units: Subjects
        White
    		 38 20 16 0 74
        Black or African American
    		 0 0 1 0 1
        Asian
    		 9 9 7 4 29
        Participant Declined to Provide
    		 1 0 0 0 1
        Not Available
    		 0 1 0 0 1
        Not Required in Country of Origin
    		 0 1 0 0 1
        Missing
    		 1 1 2 0 4
    Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 1 1 1 0 3
        Not Hispanic or Latino
    		 44 25 20 3 92
        Not Reported
    		 2 2 3 1 8
        Unknown
    		 1 2 0 0 3
        Captured as "Other"
    		 0 1 0 0 1
        Missing
    		 1 1 2 0 4

    End points

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    End points reporting groups
    Reporting group title
    Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements
    Reporting group description
    		 Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Cohort B: known or likely activating FGFR1-3 mutations
    Reporting group description
    		 Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Cohort C: other FGFR mutations or arrangements
    Reporting group description
    		 Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Other
    Reporting group description
    		 Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Primary: Objective Response Rate (ORR), defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST v1.1 or RANO, in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements

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    End point title
    		 Objective Response Rate (ORR), defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST v1.1 or RANO, in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements [1]
    End point description
    Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
    End point type
    Primary
    End point timeframe
    up to 483 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Number of subjects analysed
    49
    0 [2]
    0 [3]
    0 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    26.5 (14.95 to 41.08)
    ( to )
    ( to )
    ( to )
    Notes
    [2] - Analysis was conducted in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements.
    [3] - Analysis was conducted in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements.
    [4] - Analysis was conducted in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements.
    No statistical analyses for this end point

    Primary: ORR, defined as the percentage of participants with a best overall response of CR or PR based on RECIST v1.1 or RANO, in participants with known or likely activating FGFR1-3 mutations

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    End point title
    		 ORR, defined as the percentage of participants with a best overall response of CR or PR based on RECIST v1.1 or RANO, in participants with known or likely activating FGFR1-3 mutations [5]
    End point description
    Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
    End point type
    Primary
    End point timeframe
    up to 449 days
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Number of subjects analysed
    0 [6]
    32
    0 [7]
    0 [8]
    Units: percentage of participants
        number (confidence interval 95%)
    ( to )
    9.4 (1.98 to 25.02)
    ( to )
    ( to )
    Notes
    [6] - Analysis was conducted in participants with known or likely activating FGFR1-3 in-frame mutations.
    [7] - Analysis was conducted in participants with known or likely activating FGFR1-3 in-frame mutations.
    [8] - Analysis was conducted in participants with known or likely activating FGFR1-3 in-frame mutations.
    No statistical analyses for this end point

    Secondary: Progression-free survival (PFS) in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements and in participants with known or likely activating FGFR1-3 mutations

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    End point title
    		 Progression-free survival (PFS) in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements and in participants with known or likely activating FGFR1-3 mutations
    End point description
    PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).
    End point type
    Secondary
    End point timeframe
    up to 532 days
    End point values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Number of subjects analysed
    49
    32
    0 [9]
    0 [10]
    Units: months
        median (confidence interval 95%)
    4.53 (3.58 to 6.28)
    3.68 (2.07 to 4.47)
    ( to )
    ( to )
    Notes
    [9] - Analysis was conducted in participants in Cohorts A and B.
    [10] - Analysis was conducted in participants in Cohorts A and B.
    No statistical analyses for this end point

    Secondary: Duration of response (DOR), defined as the first CR or PR assessment until progressive disease (PD) or death, in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements and in participants with known or likely activating FGFR1-3 mutations

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    End point title
    		 Duration of response (DOR), defined as the first CR or PR assessment until progressive disease (PD) or death, in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements and in participants with known or likely activating FGFR1-3 mutations
    End point description
    Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.
    End point type
    Secondary
    End point timeframe
    up to 24.90 months
    End point values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Number of subjects analysed
    13 [11]
    3 [12]
    0 [13]
    0 [14]
    Units: months
        median (confidence interval 95%)
    7.79 (4.17 to 9999)
    6.93 (4.01 to 9999)
    ( to )
    ( to )
    Notes
    [11] - 9999=not estimable; too few participants had PD/died. Participants with CR or PR were analyzed.
    [12] - 9999=not estimable; too few participants had PD/died. Participants with CR or PR were analyzed.
    [13] - Analysis was conducted in participants in Cohorts A and B.
    [14] - Analysis was conducted in participants in Cohorts A and B.
    No statistical analyses for this end point

    Secondary: Overall survival in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements and in participants with known or likely activating FGFR1-3 mutations

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    End point title
    		 Overall survival in participants with FGFR1-3 in-frame fusions or FGFR2 arrangements and in participants with known or likely activating FGFR1-3 mutations
    End point description
    Overall survival was defined as the time from the first dose of study drug to death of any cause. 9999=the upper limit of the confidence interval was not estimable because too few participants had died.
    End point type
    Secondary
    End point timeframe
    up to 532 days
    End point values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Number of subjects analysed
    49
    32
    0 [15]
    0 [16]
    Units: months
        median (confidence interval 95%)
    17.48 (7.79 to 9999)
    11.37 (6.57 to 9999)
    ( to )
    ( to )
    Notes
    [15] - Analysis was conducted in participants in Cohorts A and B.
    [16] - Analysis was conducted in participants in Cohorts A and B.
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-emergent adverse event (TEAE) and any treatment-related adverse event (AE)

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    End point title
    		 Number of participants with any treatment-emergent adverse event (TEAE) and any treatment-related adverse event (AE)
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.
    End point type
    Secondary
    End point timeframe
    up to 651 days
    End point values
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Cohort C: other FGFR mutations or arrangements Other
    Number of subjects analysed
    49
    32
    26
    4
    Units: participants
        TEAEs
    49
    32
    26
    4
        Treatment-related AEs
    46
    32
    26
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 651 days
    Adverse event reporting additional description
    Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements
    Reporting group description
    		 Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Cohort B: known or likely activating FGFR1-3 mutations
    Reporting group description
    		 Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Other
    Reporting group description
    		 Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Reporting group title
    Cohort C: other FGFR mutations or arrangements
    Reporting group description
    		 Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.

    Serious adverse events
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Total Other Cohort C: other FGFR mutations or arrangements
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 49 (42.86%)
    7 / 32 (21.88%)
    40 / 111 (36.04%)
    2 / 4 (50.00%)
    10 / 26 (38.46%)
         number of deaths (all causes)
    18
    17
    52
    4
    13
         number of deaths resulting from adverse events
    2
    2
    6
    0
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 32 (3.13%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 2
    Oedema peripheral
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 32 (3.13%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Product issues
    Stent malfunction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 32 (3.13%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haematuria
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Long QT syndrome
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Corneal erosion
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 32 (0.00%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary obstruction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cutaneous calcification
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 32 (3.13%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fascial infection
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 32 (3.13%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 32 (3.13%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 32 (3.13%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A: FGFR1-3 in-frame fusions or FGFR2 arrangements Cohort B: known or likely activating FGFR1-3 mutations Total Other Cohort C: other FGFR mutations or arrangements
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 49 (100.00%)
    32 / 32 (100.00%)
    111 / 111 (100.00%)
    4 / 4 (100.00%)
    26 / 26 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 32 (0.00%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    3
    0
    4
    0
    1
    Hypotension
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 32 (12.50%)
    6 / 111 (5.41%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    6
    8
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 49 (16.33%)
    11 / 32 (34.38%)
    27 / 111 (24.32%)
    0 / 4 (0.00%)
    8 / 26 (30.77%)
         occurrences all number
    8
    15
    32
    0
    9
    Fatigue
         subjects affected / exposed
    10 / 49 (20.41%)
    9 / 32 (28.13%)
    23 / 111 (20.72%)
    0 / 4 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    14
    11
    29
    0
    4
    Malaise
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 32 (12.50%)
    5 / 111 (4.50%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    4
    5
    1
    0
    Oedema peripheral
         subjects affected / exposed
    6 / 49 (12.24%)
    5 / 32 (15.63%)
    13 / 111 (11.71%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    6
    5
    13
    0
    2
    Pyrexia
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 32 (9.38%)
    8 / 111 (7.21%)
    2 / 4 (50.00%)
    1 / 26 (3.85%)
         occurrences all number
    2
    3
    8
    2
    1
    Xerosis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    3
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 49 (6.12%)
    6 / 32 (18.75%)
    11 / 111 (9.91%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    3
    7
    12
    0
    2
    Dyspnoea
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 32 (12.50%)
    9 / 111 (8.11%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    3
    5
    10
    0
    2
    Epistaxis
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 32 (9.38%)
    9 / 111 (8.11%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    5
    3
    9
    0
    1
    Nasal dryness
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    1
    4
    0
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 32 (0.00%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    Depression
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 32 (0.00%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    Insomnia
         subjects affected / exposed
    4 / 49 (8.16%)
    0 / 32 (0.00%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    4
    0
    4
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 49 (12.24%)
    5 / 32 (15.63%)
    14 / 111 (12.61%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    8
    5
    16
    0
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 32 (0.00%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    2
    0
    4
    0
    2
    Blood creatinine increased
         subjects affected / exposed
    10 / 49 (20.41%)
    3 / 32 (9.38%)
    18 / 111 (16.22%)
    0 / 4 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    10
    3
    18
    0
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 49 (10.20%)
    4 / 32 (12.50%)
    14 / 111 (12.61%)
    0 / 4 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    9
    5
    20
    0
    6
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    1 / 111 (0.90%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Lipase increased
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 32 (3.13%)
    5 / 111 (4.50%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    3
    1
    7
    0
    3
    Neutrophil count decreased
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    Weight decreased
         subjects affected / exposed
    8 / 49 (16.33%)
    6 / 32 (18.75%)
    16 / 111 (14.41%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    9
    6
    17
    0
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    4
    1
    5
    0
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    10 / 49 (20.41%)
    14 / 32 (43.75%)
    30 / 111 (27.03%)
    0 / 4 (0.00%)
    6 / 26 (23.08%)
         occurrences all number
    12
    17
    36
    0
    7
    Dizziness
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 32 (3.13%)
    7 / 111 (6.31%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    5
    3
    9
    0
    1
    Headache
         subjects affected / exposed
    5 / 49 (10.20%)
    0 / 32 (0.00%)
    7 / 111 (6.31%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    5
    0
    7
    0
    2
    Presyncope
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    Taste disorder
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 32 (6.25%)
    5 / 111 (4.50%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    5
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 49 (16.33%)
    4 / 32 (12.50%)
    14 / 111 (12.61%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    9
    4
    15
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 32 (6.25%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    2
    5
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    12 / 49 (24.49%)
    9 / 32 (28.13%)
    25 / 111 (22.52%)
    0 / 4 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    13
    10
    28
    0
    5
    Keratitis
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 32 (0.00%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    2
    0
    4
    0
    2
    Serous retinal detachment
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 32 (9.38%)
    9 / 111 (8.11%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    6
    3
    10
    0
    1
    Vision blurred
         subjects affected / exposed
    5 / 49 (10.20%)
    3 / 32 (9.38%)
    8 / 111 (7.21%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    5
    4
    9
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    7 / 111 (6.31%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    3
    2
    8
    0
    3
    Abdominal pain
         subjects affected / exposed
    7 / 49 (14.29%)
    3 / 32 (9.38%)
    15 / 111 (13.51%)
    0 / 4 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    10
    3
    18
    0
    5
    Cheilitis
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    Constipation
         subjects affected / exposed
    18 / 49 (36.73%)
    13 / 32 (40.63%)
    37 / 111 (33.33%)
    0 / 4 (0.00%)
    6 / 26 (23.08%)
         occurrences all number
    20
    18
    44
    0
    6
    Dyspepsia
         subjects affected / exposed
    1 / 49 (2.04%)
    4 / 32 (12.50%)
    6 / 111 (5.41%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    5
    7
    0
    1
    Dry mouth
         subjects affected / exposed
    13 / 49 (26.53%)
    11 / 32 (34.38%)
    32 / 111 (28.83%)
    1 / 4 (25.00%)
    7 / 26 (26.92%)
         occurrences all number
    15
    13
    37
    1
    8
    Diarrhoea
         subjects affected / exposed
    19 / 49 (38.78%)
    17 / 32 (53.13%)
    43 / 111 (38.74%)
    0 / 4 (0.00%)
    7 / 26 (26.92%)
         occurrences all number
    28
    30
    65
    0
    7
    Dysphagia
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 32 (0.00%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    Nausea
         subjects affected / exposed
    11 / 49 (22.45%)
    8 / 32 (25.00%)
    27 / 111 (24.32%)
    2 / 4 (50.00%)
    6 / 26 (23.08%)
         occurrences all number
    12
    12
    33
    2
    7
    Stomatitis
         subjects affected / exposed
    27 / 49 (55.10%)
    17 / 32 (53.13%)
    59 / 111 (53.15%)
    2 / 4 (50.00%)
    13 / 26 (50.00%)
         occurrences all number
    39
    25
    87
    2
    21
    Vomiting
         subjects affected / exposed
    10 / 49 (20.41%)
    5 / 32 (15.63%)
    20 / 111 (18.02%)
    0 / 4 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    14
    6
    25
    0
    5
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 32 (0.00%)
    2 / 111 (1.80%)
    1 / 4 (25.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    0
    3
    2
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    20 / 49 (40.82%)
    17 / 32 (53.13%)
    45 / 111 (40.54%)
    0 / 4 (0.00%)
    8 / 26 (30.77%)
         occurrences all number
    20
    21
    49
    0
    8
    Dry skin
         subjects affected / exposed
    6 / 49 (12.24%)
    6 / 32 (18.75%)
    18 / 111 (16.22%)
    1 / 4 (25.00%)
    5 / 26 (19.23%)
         occurrences all number
    7
    7
    21
    1
    6
    Erythema
         subjects affected / exposed
    4 / 49 (8.16%)
    0 / 32 (0.00%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    5
    0
    5
    0
    0
    Nail discolouration
         subjects affected / exposed
    7 / 49 (14.29%)
    4 / 32 (12.50%)
    13 / 111 (11.71%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    7
    4
    13
    0
    2
    Nail disorder
         subjects affected / exposed
    4 / 49 (8.16%)
    4 / 32 (12.50%)
    10 / 111 (9.01%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    4
    4
    10
    0
    2
    Onychalgia
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 32 (6.25%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    2
    4
    0
    0
    Onycholysis
         subjects affected / exposed
    2 / 49 (4.08%)
    5 / 32 (15.63%)
    10 / 111 (9.01%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    3
    6
    12
    0
    3
    Onychomadesis
         subjects affected / exposed
    7 / 49 (14.29%)
    6 / 32 (18.75%)
    17 / 111 (15.32%)
    0 / 4 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    8
    6
    18
    0
    4
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    13 / 49 (26.53%)
    8 / 32 (25.00%)
    26 / 111 (23.42%)
    0 / 4 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    15
    11
    31
    0
    5
    Pruritus
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 32 (12.50%)
    6 / 111 (5.41%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    2
    4
    6
    0
    0
    Rash
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 32 (6.25%)
    5 / 111 (4.50%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    2
    5
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 32 (6.25%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 32 (6.25%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    5
    5
    0
    0
    Urinary retention
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 32 (6.25%)
    6 / 111 (5.41%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    4
    2
    6
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 32 (9.38%)
    5 / 111 (4.50%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    1
    3
    5
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 32 (12.50%)
    8 / 111 (7.21%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    3
    4
    8
    0
    1
    Arthritis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 32 (6.25%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    Arthralgia
         subjects affected / exposed
    11 / 49 (22.45%)
    11 / 32 (34.38%)
    23 / 111 (20.72%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    12
    14
    27
    0
    1
    Muscle spasms
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    2
    5
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 32 (6.25%)
    2 / 111 (1.80%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    Myalgia
         subjects affected / exposed
    4 / 49 (8.16%)
    4 / 32 (12.50%)
    10 / 111 (9.01%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    4
    4
    10
    0
    2
    Pain in extremity
         subjects affected / exposed
    7 / 49 (14.29%)
    0 / 32 (0.00%)
    10 / 111 (9.01%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    8
    0
    11
    0
    3
    Osteoarthritis
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    1
    2
    3
    0
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    4 / 49 (8.16%)
    0 / 32 (0.00%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    4
    0
    4
    0
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 32 (6.25%)
    7 / 111 (6.31%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    2
    2
    8
    0
    4
    Cystitis
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    1
    4
    0
    0
    Nail infection
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 32 (6.25%)
    3 / 111 (2.70%)
    0 / 4 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    2
    3
    0
    1
    Paronychia
         subjects affected / exposed
    5 / 49 (10.20%)
    6 / 32 (18.75%)
    14 / 111 (12.61%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    5
    7
    15
    0
    3
    Urinary tract infection
         subjects affected / exposed
    6 / 49 (12.24%)
    5 / 32 (15.63%)
    15 / 111 (13.51%)
    0 / 4 (0.00%)
    4 / 26 (15.38%)
         occurrences all number
    6
    5
    16
    0
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 49 (20.41%)
    12 / 32 (37.50%)
    27 / 111 (24.32%)
    0 / 4 (0.00%)
    5 / 26 (19.23%)
         occurrences all number
    14
    15
    34
    0
    5
    Dehydration
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    1
    4
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    1
    4
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 32 (9.38%)
    8 / 111 (7.21%)
    0 / 4 (0.00%)
    3 / 26 (11.54%)
         occurrences all number
    4
    3
    15
    0
    8
    Hyperphosphataemia
         subjects affected / exposed
    45 / 49 (91.84%)
    27 / 32 (84.38%)
    93 / 111 (83.78%)
    4 / 4 (100.00%)
    17 / 26 (65.38%)
         occurrences all number
    72
    51
    154
    4
    27
    Hypokalaemia
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    0 / 26 (0.00%)
         occurrences all number
    3
    1
    4
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 32 (3.13%)
    7 / 111 (6.31%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences all number
    5
    2
    8
    1
    0
    Hyponatraemia
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 32 (3.13%)
    6 / 111 (5.41%)
    1 / 4 (25.00%)
    0 / 26 (0.00%)
         occurrences all number
    5
    1
    7
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    4 / 49 (8.16%)
    3 / 32 (9.38%)
    10 / 111 (9.01%)
    1 / 4 (25.00%)
    2 / 26 (7.69%)
         occurrences all number
    4
    3
    12
    1
    4
    Vitamin D deficiency
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 32 (3.13%)
    4 / 111 (3.60%)
    0 / 4 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    2
    1
    5
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Feb 2019
    The protocol was amended to incorporate updates based on Voluntary Harmonization Procedure review of other pemigatinib protocols and to update safety information based on the revised/updated Investigator's Brochure.
    14 Jan 2020
    The protocol was amended to incorporate updates of the cohort definitions and other changes based on Food and Drug Administration review of other pemigatinib protocols.
    15 Feb 2021
    The protocol was amended to incorporate updates regarding tumor biopsy timing and other clarifications.

    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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