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    Clinical Trial Results:
    A Phase 3, Multicenter, Prospective, Randomized, Open label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 with Near infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries

    Summary
    EudraCT number
    		 2025-000122-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jul 2025
    First version publication date
    31 Jul 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    5354-CL-0301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05754333
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astellas Pharma Global Development, Inc
    Sponsor organisation address
    Northbrook, IL, United States, 60062
    Public contact
    Clinical Transparency, Astellas Pharma Global Development Inc., 847/224 8008887704, astellas.resultsdisclosure@astellas.com
    Scientific contact
    Clinical Transparency, Astellas Pharma Global Development Inc, 847/224 8008887704, astellas.resultsdisclosure@astellas.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-003099-PIP01-21
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 Jan 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was the investigator’s blinded conspicuity assessment of the ureter at the first time point for adults with normal renal function or mild renal impairment.
    Protection of trial subjects
    This clinical study was written, conducted and reported in accordance with the protocol, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki. Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2023
    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
    United States: 107
    Worldwide total number of subjects
    107
    EEA total number of subjects
    0
    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)
    14
    Adults (18-64 years)
    59
    From 65 to 84 years
    33
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adults with normal renal function (NRF), mild renal impairment( MRI) [estimated glomerular filtration rate (eGFR)≥ 60 milliliter/minute (mL/min)], adults with moderate or severe renal impairment (SRI) [eGFR≥ 15 to < 60 mL/min] and adolescents with NRF or MRI [eGFR ≥ 60mL/min]) were enrolled in study. There were no participants enrolled with SRI.

    Pre-assignment
    Screening details
    		 Participants who met inclusion criteria and none of the exclusion criteria were enrolled in the study. Randomization was stratified by type of surgery :gynecological abdominopelvic

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adult(Normal/Mild):White Light/near-infraredfluorescence
    Arm description
    		 Pudexacianinium (3 milligrams [mg]) was administered as a single intravenous (IV) dose approximately 30 minutes (min) before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. White Light (WL) and near-infrared fluorescence (NIR-F) were used to recognize/identify the ureter.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pudexacianinium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single IV 3 mg dose

    Arm title
    		 Adult(Normal/Mild):White Light only
    Arm description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL was used to recognize/identify the ureter.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pudexacianinium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single IV 3 mg dose

    Arm title
    		 Adult (Moderate):White Light/near-infraredfluorescence
    Arm description
    		 Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pudexacianinium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single IV 3 mg dose

    Arm title
    		 Adolescent(Normal/Mild):White Light/near-infraredfluorescence
    Arm description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pudexacianinium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    single IV 3 mg dose

    Number of subjects in period 1
    		Adult(Normal/Mild):White Light/near-infraredfluorescence Adult(Normal/Mild):White Light only Adult (Moderate):White Light/near-infraredfluorescence Adolescent(Normal/Mild):White Light/near-infraredfluorescence
    Started
    72
    13
    8
    14
    Participants did not receive study drug
    2 [1]
    0 [2]
    0 [3]
    0 [4]
    Completed
    67
    12
    8
    13
    Not completed
    5
    1
    0
    1
         Lost to follow-up
    2
    1
    -
    1
         miscellaneous
    3
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Two participants did not receive the study drug.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All participants in this arm received the study drug.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All participants in this arm received the study drug.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: All participants in this arm received the study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adult(Normal/Mild):White Light/near-infraredfluorescence
    Reporting group description
    		 Pudexacianinium (3 milligrams [mg]) was administered as a single intravenous (IV) dose approximately 30 minutes (min) before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. White Light (WL) and near-infrared fluorescence (NIR-F) were used to recognize/identify the ureter.

    Reporting group title
    Adult(Normal/Mild):White Light only
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL was used to recognize/identify the ureter.

    Reporting group title
    Adult (Moderate):White Light/near-infraredfluorescence
    Reporting group description
    		 Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Reporting group title
    Adolescent(Normal/Mild):White Light/near-infraredfluorescence
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Reporting group values
    		 Adult(Normal/Mild):White Light/near-infraredfluorescence Adult(Normal/Mild):White Light only Adult (Moderate):White Light/near-infraredfluorescence Adolescent(Normal/Mild):White Light/near-infraredfluorescence Total
    Number of subjects
    		 72 13 8 14
    Age categorical
    Units: Subjects
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 54.5 ( 14.9 ) 52.2 ( 21.6 ) 70.3 ( 8.6 ) 14.4 ( 1.7 ) -
    Sex
    Units: Participants
        Female
    		 49 10 6 8 73
        Male
    		 23 3 2 6 34
    Race
    Units: Subjects
        Asian
    		 5 0 1 1 7
        Black or African American
    		 9 2 0 1 12
        Not Reported
    		 5 0 0 0 5
        White
    		 53 11 7 12 83
    Ethnicity
    Units: Subjects
        HISPANIC OR LATINO
    		 11 1 2 4 18
        NOT HISPANIC OR LATINO
    		 59 12 6 10 87
        NOT REPORTED
    		 2 0 0 0 2
    Type of Surgery (Gynecological & Other-Abdominopelvic)
    Units: Subjects
        GYNECOLOGICAL
    		 15 2 0 7 24
        Other-Abdominopelvic
    		 57 11 8 7 83

    End points

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    End points reporting groups
    Reporting group title
    Adult(Normal/Mild):White Light/near-infraredfluorescence
    Reporting group description
    		 Pudexacianinium (3 milligrams [mg]) was administered as a single intravenous (IV) dose approximately 30 minutes (min) before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. White Light (WL) and near-infrared fluorescence (NIR-F) were used to recognize/identify the ureter.

    Reporting group title
    Adult(Normal/Mild):White Light only
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL was used to recognize/identify the ureter.

    Reporting group title
    Adult (Moderate):White Light/near-infraredfluorescence
    Reporting group description
    		 Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Reporting group title
    Adolescent(Normal/Mild):White Light/near-infraredfluorescence
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Subject analysis set title
    Adult (Normal/Mild): WL/NIR-F (Only WL)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.

    Subject analysis set title
    Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.

    Subject analysis set title
    Adolescent (Normal/Mild): WL/NIR-F (Only WL)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm.

    Subject analysis set title
    Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm.

    Subject analysis set title
    Adult (Moderate): WL/NIR-F (Only WL)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm.

    Subject analysis set title
    Adult (Moderate): WL/NIR-F (Only NIR-F )
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm.

    Subject analysis set title
    All Participants: WL/NIR-F (Only WL)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm.

    Subject analysis set title
    All Participants: WL/NIR-F (Only NIR-F)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm.

    Subject analysis set title
    Adult(Normal/Mild):WL/NIR-F
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Subject analysis set title
    Adult(Normal/Mild):White Light only
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL was used to recognize/identify the ureter.

    Subject analysis set title
    All Participants: White Light+near-infrared fluorescence
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Subject analysis set title
    Adult (Moderate):White Light/Near-infraredfluorescence
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3mg) was administered as a single IV dose approximately 30min before ureter visualization, onDay 1 in adult participants with moderate renal impairment. WL and NIR-F were used torecognize/identifythe ureter.

    Subject analysis set title
    Adolescent(Normal/Mild):White Light/Near-infraredfluorescence
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F wereused torecognize/identifythe ureter.

    Primary: Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adult (Normal/Mild): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adult (Normal/Mild): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores fromone ureter. Intent to Treat (ITT): All participants in the adult normal/mild (eGFR) cohort randomized to WL/NIR-F.
    End point type
    Primary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: score on a scale
        arithmetic mean (standard deviation)
    2.7 ( 1.5 )
    4.3 ( 1.2 )
    Statistical analysis title
    		 statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 paired t Test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult(Normal/Mild): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult(Normal/Mild): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. ITT with available data was analyzed. 99999 denotes not applicable (NA) as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n= 72,72)
    2.7 ( 1.5 )
    4.3 ( 1.2 )
        60 minutes (n== 0,50)
    99999 ( 99999 )
    4.3 ( 1.2 )
        90 minutes (n= 0,45)
    99999 ( 99999 )
    4.2 ( 1.1 )
        120 minutes (n= 0,33)
    99999 ( 99999 )
    4.2 ( 1.1 )
        150 minutes (n= 0,23)
    99999 ( 99999 )
    3.8 ( 1.4 )
        180 minutes (n= 0,17)
    99999 ( 99999 )
    3.8 ( 1.3 )
        210 minutes (n= 0,9)
    99999 ( 99999 )
    3.9 ( 1.7 )
        240 minutes (n= 0,3)
    99999 ( 99999 )
    4.7 ( 0.6 )
        270 minutes (n= 0,4)
    99999 ( 99999 )
    4.5 ( 1.0 )
        300 minutes (n= 0,2)
    99999 ( 99999 )
    5.0 ( 0.0 )
        330 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        450 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        480 minutes (n= 0,2)
    99999 ( 99999 )
    4.0 ( 1.4 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Sign test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Normal/Mild):WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Normal/Mild):WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. ITT population. 99999 denotes NA as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n=72,0)
    2.7 ( 1.5 )
    99999 ( 99999 )
        End of surgery (Day 1) (n= 0,72)
    99999 ( 99999 )
    4.0 ( 1.3 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 paired t Test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Secondary: Quantification of ureter conspicuity for WL and NIR-F illumination modes [Adult (Normal/Mild): WL/NIR-F]

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    End point title
    		 Quantification of ureter conspicuity for WL and NIR-F illumination modes [Adult (Normal/Mild): WL/NIR-F]
    End point description
    Ureter conspicuity was quantified by image analysis measuring the color contrast when pudexacianinium chloride was present in the ureter. Contrast enhancement factor (CEF) was a measure of the degree to which color contrast was enhanced in areas in which study drug fluorescence signal was present when compared to areas in which study drug fluorescence signal was absent. Overall average data of each time point from first dose up to end of surgery was reported. ITT.
    End point type
    Secondary
    End point timeframe
    From first dose every 30 minutes thereafter up to end of surgery (Day 1)
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: ratio
        arithmetic mean (standard deviation)
    1.08 ( 0.15 )
    2.38 ( 1.54 )
    No statistical analyses for this end point

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adolescent (Normal/Mild): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adolescent (Normal/Mild): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Modified Intent to Treat (mITT): All adolescent participants in the WL/NIR-F arm. 99999 denotes Not applicable (NA).
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 Adolescent (Normal/Mild): WL/NIR-F (Only WL) Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    14
    14
    Units: score on a scale
        arithmetic mean (standard deviation)
    3.5 ( 1.5 )
    4.4 ( 1.2 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [1] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adolescent(Normal/Mild): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adolescent(Normal/Mild): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mITT in adolescents with available data was analyzed. 99999 denotes NA, as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes
    End point values
    		 Adolescent (Normal/Mild): WL/NIR-F (Only WL) Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    14
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n=14,14)
    3.5 ( 1.5 )
    4.4 ( 1.2 )
        60 minutes (n= 0,11)
    99999 ( 99999 )
    4.5 ( 0.5 )
        90 minutes (n= 0,4)
    99999 ( 99999 )
    4.5 ( 0.6 )
        120 minutes (n= 0, 1)
    99999 ( 99999 )
    5.0 ( 99999 )
        150 minutes (n= 0, 1)
    99999 ( 99999 )
    4.0 ( 99999 )
        180 minutes (n= 0, 1)
    99999 ( 99999 )
    4.0 ( 99999 )
        210 minutes (n= 0, 1)
    99999 ( 99999 )
    2.0 ( 99999 )
    Statistical analysis title
    		 Statitical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [2] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adolescent(Normal/Mild): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adolescent(Normal/Mild): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores fromone ureter. mIIT in adolescents. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 Adolescent (Normal/Mild): WL/NIR-F (Only WL) Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    14
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n= 14,0)
    3.5 ( 1.5 )
    99999 ( 99999 )
        End of surgery (Day 1) (n= 0,14)
    99999 ( 99999 )
    4.4 ( 0.9 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [3] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adult (Moderate): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adult (Moderate): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mIIT in adults with moderate eGFR in the WL/NIR-F arm. 99999 denotes NA.
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 Adult (Moderate): WL/NIR-F (Only WL) Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects analysed
    8
    8
    Units: score on a scale
        arithmetic mean (standard deviation)
    1.4 ( 0.7 )
    2.9 ( 1.1 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [4] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult(Moderate): WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult(Moderate): WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mITT in adults with moderate eGFR with available data was analyzed. 99999 denotes NA as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes
    End point values
    		 Adult (Moderate): WL/NIR-F (Only WL) Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects analysed
    8
    8
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n= 8,8)
    14 ( 0.7 )
    2.9 ( 1.1 )
        60 minutes (n= 0,5)
    99999 ( 99999 )
    4.2 ( 1.1 )
        90 minutes (n= 0,5)
    99999 ( 99999 )
    3.2 ( 1.6 )
        120 minutes (n= 0,5)
    99999 ( 99999 )
    3.8 ( 1.1 )
        150 minutes (n= 0,3)
    99999 ( 99999 )
    2.7 ( 1.5 )
        180 minutes (n= 0,1)
    99999 ( 99999 )
    2.0 ( 99999 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [5] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Moderate):WL/NIR-F]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Moderate):WL/NIR-F]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mITT in adults with moderate eGFR. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 Adult (Moderate): WL/NIR-F (Only WL) Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects analysed
    8
    8
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n=8,0)
    14 ( 0.7 )
    99999 ( 99999 )
        End of surgery (Day1) (n= 0,8)
    99999 ( 99999 )
    2.9 ( 1.5 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.6
    Notes
    [6] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [All participants]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [All participants]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mITT for any cohorts in WL/NIR-F arm. 99999 denotes NA.
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 All Participants: WL/NIR-F (Only WL) All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    94
    94
    Units: score on a scale
        arithmetic mean (standard deviation)
    2.7 ( 1.6 )
    4.2 ( 1.2 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [7] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [All participants]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [All participants]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mITT for all cohorts in WL/NIR-F arm with available data was analyzed. 99999 denotes NA as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes
    End point values
    		 All Participants: WL/NIR-F (Only WL) All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    94
    94
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n= 94,94)
    2.7 ( 1.6 )
    4.2 ( 1.2 )
        60 minutes (n= 0,66)
    99999 ( 99999 )
    4.3 ( 1.3 )
        90 minutes (n= 0,54)
    99999 ( 99999 )
    4.1 ( 1.1 )
        120 minutes (n= 0,39)
    99999 ( 99999 )
    4.2 ( 1.1 )
        150 minutes (n= 0,27)
    99999 ( 99999 )
    3.7 ( 1.4 )
        180 minutes (n= 0,19)
    99999 ( 99999 )
    3.7 ( 1.3 )
        210 minutes (n= 0,10)
    99999 ( 99999 )
    3.7 ( 1.7 )
        240 minutes (n= 0,3)
    99999 ( 99999 )
    4.7 ( 0.6 )
        270 minutes (n= 0,4)
    99999 ( 99999 )
    4.5 ( 1.0 )
        300 minutes (n= 0,2)
    99999 ( 9999 )
    5.0 ( 0.0 )
        330 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        450 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        480 minutes (n= 0,2)
    99999 ( 99999 )
    4.0 ( 1.4 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [8] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [All participants]

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    End point title
    		 Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [All participants]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. mITT for all cohorts in WL/NIR-F arm. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 All Participants: WL/NIR-F (Only WL) All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    94
    94
    Units: score on a scale
    arithmetic mean (standard deviation)
        30 minutes (n= 94,0)
    2.7 ( 1.6 )
    99999 ( 99999 )
        End of surgery (Day 1) (n= 0,94)
    99999 ( 99999 )
    4.0 ( 1.3 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [9] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Percentage of participants with an average index ureter conspicuity under NIR-F at least 2,3 or 4 point higher than the average index ureter conspicuity under WL over all time points [All Participants]

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    End point title
    		 Percentage of participants with an average index ureter conspicuity under NIR-F at least 2,3 or 4 point higher than the average index ureter conspicuity under WL over all time points [All Participants]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Mean data from first dose and every 30 minutes thereafter up to end of surgery was evaluated and reported. mITT for all cohorts in WL/NIR-F arm.
    End point type
    Secondary
    End point timeframe
    From first dose every 30 minute thereafter up to end of surgery (Day 1)
    End point values
    		 All Participants: White Light+near-infrared fluorescence
    Number of subjects analysed
    94
    Units: percentage of participants
    number (not applicable)
        2 points higher
    40.4
        3 points higher
    20.2
        4 points higher
    2.1
    No statistical analyses for this end point

    Secondary: Percentage of participants with an average index ureter conspicuity under NIR-F at least 1 point higher than the average index ureter conspicuity under WL over all time points [All Participants]

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    End point title
    		 Percentage of participants with an average index ureter conspicuity under NIR-F at least 1 point higher than the average index ureter conspicuity under WL over all time points [All Participants]
    End point description
    Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident),4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Mean data from first dose and every 30 minutes thereafter up to end of surgery was evaluated and reported. mITT for all cohorts in WL/NIR-F arm.
    End point type
    Secondary
    End point timeframe
    From first dose every 30 minute thereafter up to end of surgery (Day 1)
    End point values
    		 All Participants: White Light+near-infrared fluorescence
    Number of subjects analysed
    94
    Units: percentage of participants
        number (not applicable)
    67.0
    No statistical analyses for this end point

    Secondary: Blinded Independent Central Reviewer (BICR) Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes (Adult (Normal/Mild): WL/NIR-F) and Concordance correlation coefficient (CCC) between Investigator and BICR reader

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    End point title
    		 Blinded Independent Central Reviewer (BICR) Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes (Adult (Normal/Mild): WL/NIR-F) and Concordance correlation coefficient (CCC) between Investigator and BICR reader
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Concordance correlation coefficient (CCC) measures the agreement between investigator and BICR reader for the value difference between WL + NIR-F at 30 min timepoint. Results were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes is reported in Outcome measure #1. ITT.
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2
    1.5 ( 0.9 )
    3.4 ( 1.4 )
        Reader 3
    2.1 ( 1.3 )
    3.2 ( 1.3 )
        Reader 4
    2.0 ( 1.1 )
    4.3 ( 1.4 )
    Statistical analysis title
    		 Statistical analysis 1,For reader 2
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 < 0.001
    Method
    		 paired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 2.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [10] - Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Statistical analysis title
    		 Statistical analysis 2, CCC, Reader 2
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.221
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.011
         upper limit
    		 0.431
    Notes
    [11] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 3, For reader 3
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 < 0.001
    Method
    		 paired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [12] - Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Statistical analysis title
    		 Statistical analysis 3, CCC, Reader 3
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.053
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.181
         upper limit
    		 0.282
    Notes
    [13] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis, For reader 4
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 < 0.001
    Method
    		 paired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 2.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [14] - Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Statistical analysis title
    		 Statistical analysis 6, CCC, Reader 4
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.464
    Notes
    [15] - It quantifies the degree of concordance between two measurements

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult (Normal/Mild): WL/NIR-F] and CCC between Investigator and BICR reader

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult (Normal/Mild): WL/NIR-F] and CCC between Investigator and BICR reader
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient(sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. CCC was concordance correlation coefficient, & it measured agreement between investigator and BICR reader for value difference between WL at 30-min timepoint & average of all NIR-F time points. Result were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints was reported in Outcome measure #2. ITT with available data was analyzed. 99999 denotes NA as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2, 30 minutes (n= 72,72 )
    1.5 ( 0.9 )
    3.4 ( 1.4 )
        Reader 2, 60 minutes (n= 0,45 )
    99999 ( 99999 )
    3.5 ( 1.3 )
        Reader 2, 90 minutes (n= 0,39 )
    99999 ( 99999 )
    3.2 ( 1.4 )
        Reader 2, 120 minutes (n= 0,29 )
    99999 ( 99999 )
    3.1 ( 1.4 )
        Reader 2, 150 minutes (n= 0,20)
    99999 ( 99999 )
    3.3 ( 1.5 )
        Reader 2, 180 minutes (n= 0,15)
    99999 ( 99999 )
    3.3 ( 1.5 )
        Reader 2, 210 minutes (n=0,7 )
    99999 ( 99999 )
    3.4 ( 1.4 )
        Reader 2, 240 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        Reader 2, 270 minutes (n= 0,4)
    99999 ( 99999 )
    3.3 ( 2.1 )
        Reader 2, 300 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        Reader 2, 330 minutes (n=0,1 )
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 2, 450 minutes (n= 0,0)
    99999 ( 99999 )
    99999 ( 99999 )
        Reader 2, 480 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        Reader 3, 30 minutes (n= 72,72)
    2.1 ( 1.3 )
    3.2 ( 1.3 )
        Reader 3, 60 minutes (n= 0,45)
    99999 ( 99999 )
    3.5 ( 1.3 )
        Reader 3, 90 minutes (n= 0,39)
    99999 ( 99999 )
    3.5 ( 1.3 )
        Reader 3, 120 minutes (n= 0,29)
    99999 ( 99999 )
    3.4 ( 1.3 )
        Reader 3, 150 minutes (n= 0,20)
    99999 ( 99999 )
    3.4 ( 1.3 )
        Reader 3, 180 minutes (n= 0,15)
    99999 ( 99999 )
    3.5 ( 1.5 )
        Reader 3, 210 minutes (n= 0,7)
    99999 ( 99999 )
    3.6 ( 1.4 )
        Reader 3, 240 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 3, 270 minutes (n= 0,4)
    99999 ( 99999 )
    3.8 ( 1.9 )
        Reader 3, 300 minutes (n= 0,1)
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 3, 330 minutes (n= 0,1)
    99999 ( 99999 )
    2.0 ( 9999 )
        Reader 3, 450 minutes (n= 0,0)
    99999 ( 99999 )
    99999 ( 99999 )
        Reader 3, 480 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 9999 )
        Reader 4, 30 minutes (n= 72,72)
    2.0 ( 1.1 )
    4.3 ( 1.4 )
        Reader 4, 60 minutes (n= 0,45)
    99999 ( 99999 )
    4.4 ( 1.3 )
        Reader 4, 90 minutes (n= 0,39)
    99999 ( 99999 )
    4.5 ( 1.0 )
        Reader 4, 120 minutes (n= 0,29)
    99999 ( 99999 )
    4.4 ( 0.9 )
        Reader 4, 150 minutes (n= 0,20)
    99999 ( 99999 )
    4.7 ( 0.7 )
        Reader 4, 180 minutes (n= 0,15)
    99999 ( 99999 )
    4.3 ( 1.0 )
        Reader 4, 210 minutes (n= 0,7)
    99999 ( 99999 )
    4.3 ( 1.1 )
        Reader 4, 240 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4, 270 minutes (n= 0,4)
    99999 ( 99999 )
    4.0 ( 1.4 )
        Reader 4, 300 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4, 330 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4, 450 minutes (n= 0,0)
    99999 ( 99999 )
    99999 ( 99999 )
        Reader 4, 480 minutes (n=0,1 )
    99999 ( 99999 )
    2.0 ( 99999 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Sign test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Statistical analysis title
    		 Statistical analysis 6, CCC reader 4
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.245
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.014
         upper limit
    		 0.451
    Notes
    [16] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 4, CCC Reader 3
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.043
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.191
         upper limit
    		 0.272
    Notes
    [17] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 5 For reader 4
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [18]
    P-value
    		 < 0.001
    Method
    		 Sign test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 2.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [18] - Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Statistical analysis title
    		 Statistical analysis 2,CCC, Reader 2
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.219
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.013
         upper limit
    		 0.429
    Notes
    [19] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 3, For reader 3
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [20]
    P-value
    		 < 0.001
    Method
    		 Sign test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [20] - Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adolescent (Normal/Mild): WL/NIR-F

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adolescent (Normal/Mild): WL/NIR-F
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). Allparticipants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader4. mITT in adolescents. 99999 denotes NA.
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 Adolescent (Normal/Mild): WL/NIR-F (Only WL) Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    14
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2
    2.1 ( 1.2 )
    3.9 ( 1.3 )
        Reader 3
    2.9 ( 1.4 )
    4.1 ( 1.0 )
        Reader 4
    3.4 ( 1.4 )
    4.8 ( 0.6 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [21] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [22]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [22] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2 For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [23] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adolescent(Normal/Mild): WL/NIR-F]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adolescent(Normal/Mild): WL/NIR-F]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. mITT in adolescents with available data was analyzed. 99999 denotes NA as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes
    End point values
    		 Adolescent (Normal/Mild): WL/NIR-F (Only WL) Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    14
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 14,14)
    2.1 ( 1.2 )
    3.9 ( 1.3 )
        Reader 2: 60 minutes (n= 0,10)
    99999 ( 99999 )
    3.4 ( 1.2 )
        Reader 2: 90 minutes (n= 0,4)
    99999 ( 99999 )
    3.8 ( 1.3 )
        Reader 2: 120 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        Reader 2: 150 minutes (n=0,1 )
    999999 ( 99999 )
    2.0 ( 99999 )
        Reader 2: 180 minutes (n=0,1 )
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 2: 210 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        Reader 3: 30 minutes (n= 14,14)
    2.9 ( 1.4 )
    4.1 ( 1.0 )
        Reader 3: 60 minutes (n= 0,10)
    99999 ( 99999 )
    3.4 ( 1.0 )
        Reader 3: 90 minutes (n= 0,4)
    99999 ( 99999 )
    3.8 ( 1.0 )
        Reader 3: 120 minutes (n= 0,1)
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 3: 150 minutes (n= 0,1)
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 3: 180 minutes (n= 0,1)
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 3: 210 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        Reader 4: 30 minutes (n= 14,14)
    3.4 ( 1.3 )
    4.8 ( 0.6 )
        Reader 4: 60 minutes (n= 0,10)
    99999 ( 99999 )
    5.0 ( 0.0 )
        Reader 4: 90 minutes (n= 0,4)
    99999 ( 99999 )
    5.0 ( 0.0 )
        Reader 4: 120 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4: 150 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4: 180 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4: 210 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [24] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [25] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [26]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [26] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adolescent (Normal/Mild):WL/NIR-F]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adolescent (Normal/Mild):WL/NIR-F]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader4. miTT in adolescents. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 Adolescent (Normal/Mild): WL/NIR-F (Only WL) Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    14
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 14,0)
    2.1 ( 1.2 )
    99999 ( 99999 )
        Reader 2: End of surgery (Day 1) (n= 0,14)
    99999 ( 99999 )
    3.4 ( 1.5 )
        Reader 3: 30 minutes (n= 14,0)
    2.9 ( 1.4 )
    99999 ( 99999 )
        Reader 3: End of surgery (Day 1) (n= 0,14)
    99999 ( 99999 )
    3.6 ( 1.3 )
        Reader 4: 30 minutes (n= 14,0)
    3.4 ( 1.3 )
    99999 ( 99999 )
        Reader 4: End of surgery (Day 1) (n= 0,14)
    99999 ( 99999 )
    4.8 ( 0.6 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [27] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [28]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [28] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error
    Statistical analysis title
    		 Statistical analysis, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adolescent (Normal/Mild): WL/NIR-F (Only WL) v Adolescent (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [29] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Normal/Mild):WL/NIR-F] and CCC between Investigator and BICR reader

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Normal/Mild):WL/NIR-F] and CCC between Investigator and BICR reader
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-PointLikert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient(sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. CCC was concordance correlation coefficient, and it measures\d the agreement between investigator and BICR reader for the value difference between WL at 30-min timepoint and the end of surgery score under NIR-F. Results were reported for Reader2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery is reported in Outcome measure #3. ITT. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 Adult (Normal/Mild): WL/NIR-F (Only WL) Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    72
    72
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 72,0)
    1.5 ( 0.9 )
    99999 ( 99999 )
        Reader 2: End of surgery (Day 1) (n= 0,72)
    99999 ( 99999 )
    3.0 ( 1.4 )
        Reader 3: 30 minutes (n= 72,0)
    2.1 ( 1.3 )
    99999 ( 99999 )
        Reader 3: End of surgery (Day 1) (n= 0,72)
    99999 ( 99999 )
    3.0 ( 1.4 )
        Reader 4: 30 minutes (n= 72,0)
    2.0 ( 1.2 )
    99999 ( 99999 )
        Reader 4: End of surgery (Day 1) (n= 0,72)
    99999 ( 99999 )
    4.0 ( 1.5 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [30]
    P-value
    		 < 0.001
    Method
    		 paired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [30] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 6, CCC, Reader 4
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.297
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.495
    Notes
    [31] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 4, CCC, Reader 3
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.186
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.048
         upper limit
    		 0.4
    Notes
    [32] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 5, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [33]
    P-value
    		 < 0.001
    Method
    		 paired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 2.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [33] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, CCC, Reader 2
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    Method
    Parameter type
    		 correlation coefficient
    Point estimate
    0.339
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.116
         upper limit
    		 0.529
    Notes
    [34] - It quantifies the degree of concordance between two measurements
    Statistical analysis title
    		 Statistical analysis 3 For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Normal/Mild): WL/NIR-F (Only WL) v Adult (Normal/Mild): WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 paired t test
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adult (Moderate): WL/NIR-F]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [Adult (Moderate): WL/NIR-F]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader4. mITT in adults with moderate eGFR. 99999 denotes NA.
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 Adult (Moderate): WL/NIR-F (Only WL) Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects analysed
    8
    8
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2
    1.3 ( 0.7 )
    2.4 ( 1.4 )
        Reader 3
    1.5 ( 0.5 )
    2.4 ( 1.1 )
        Reader 4
    2.0 ( 0.9 )
    4.1 ( 1.4 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [35]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [35] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [36]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [36] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [37]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [37] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult (Moderate):WL/NIR-F]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [Adult (Moderate):WL/NIR-F]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader4. mITT in adults with moderate eGFR with available data was analyzed. 99999 denotes NA as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes
    End point values
    		 Adult (Moderate): WL/NIR-F (Only WL) Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects analysed
    8
    8
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 8,8)
    1.3 ( 0.7 )
    2.4 ( 1.4 )
        Reader 2: 60 minutes (n= 0,2)
    99999 ( 99999 )
    3.5 ( 2.1 )
        Reader 2: 90 minutes (n= 0,4)
    99999 ( 99999 )
    2.8 ( 1.5 )
        Reader 2: 120 minutes (n= 0,4)
    99999 ( 99999 )
    2.8 ( 1.7 )
        Reader 2: 150 minutes (n= 0,3)
    99999 ( 99999 )
    2.3 ( 0.6 )
        Reader 2: 180 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        Reader 3: 30 minutes (n= 8,8)
    1.5 ( 0.5 )
    2.4 ( 1.1 )
        Reader 3: 60 minutes (n= 0,2)
    99999 ( 99999 )
    3.5 ( 2.1 )
        Reader 3: 90 minutes (n= 0,4)
    99999 ( 99999 )
    2.8 ( 1.5 )
        Reader 3: 120 minutes (n= 0,4)
    99999 ( 99999 )
    3.0 ( 1.6 )
        Reader 3: 150 minutes (n= 0,3)
    99999 ( 99999 )
    2.3 ( 0.6 )
        Reader 3 180 minutes (n= 0,1)
    99999 ( 99999 )
    2.0 ( 99999 )
        Reader 4: 30 minutes (n= 8,8)
    2.0 ( 0.9 )
    4.1 ( 1.4 )
        Reader 4: 60 minutes (n= 0,2)
    99999 ( 99999 )
    4.5 ( 0.7 )
        Reader 4: 90 minutes (n= 0,4)
    99999 ( 99999 )
    5.0 ( 0.0 )
        Reader 4: 120 minutes (n=0,4 )
    99999 ( 99999 )
    3.8 ( 1.5 )
        Reader 4: 150 minutes (n= 0,3)
    99999 ( 99999 )
    4.7 ( 0.6 )
        Reader 4: 180 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
    Statistical analysis title
    		 Statistical analysis, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [38]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [38] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [39]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [39] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [40]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [40] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Moderate): WL/NIR-F]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [Adult (Moderate): WL/NIR-F]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader4. mITT in adults with moderate eGFR. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 Adult (Moderate): WL/NIR-F (Only WL) Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects analysed
    8
    8
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 8,0)
    1.3 ( 0.7 )
    99999 ( 99999 )
        Reader 2: End of Surgery (Day 1) (n= 0,8)
    99999 ( 99999 )
    2.3 ( 1.3 )
        Reader 3: 30 minutes (n= 8,0)
    1.5 ( 0.5 )
    99999 ( 99999 )
        Reader 3: End of Surgery (Day 1) (n= 0,8)
    99999 ( 99999 )
    2.6 ( 1.1 )
        Reader 4: 30 minutes (n= 8,0)
    2.0 ( 0.9 )
    99999 ( 99999 )
        Reader 4: End of Surgery (Day 1) (n= 0,8)
    99999 ( 99999 )
    4.0 ( 1.1 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [41]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Notes
    [41] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [42]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Notes
    [42] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    Adult (Moderate): WL/NIR-F (Only WL) v Adult (Moderate): WL/NIR-F (Only NIR-F )
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [43]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Notes
    [43] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [All Participants]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes [All Participants]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. mITT for all cohorts in WL/NIR-F arm.
    End point type
    Secondary
    End point timeframe
    30 minutes post dose (+/- 15 minutes)
    End point values
    		 All Participants: WL/NIR-F (Only WL) All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    94
    94
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2
    1.6 ( 0.9 )
    3.4 ( 1.4 )
        Reader 3
    2.1 ( 1.3 )
    3.3 ( 1.3 )
        Reader 4
    2.2 ( 1.2 )
    4.3 ( 1.3 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [44]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [44] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [45]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [45] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [46]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [46] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [All Participants]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints [All Participants]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. mITT for all cohorts in WL/NIR-F arm with available data was analyzed. 99999 denotes NA as either no participants were evaluable or only 1 participant was evaluable, thus SD not reported.
    End point type
    Secondary
    End point timeframe
    WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes
    End point values
    		 All Participants: WL/NIR-F (Only WL) All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    94
    94
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 94,94)
    1.6 ( 0.9 )
    3.4 ( 1.4 )
        Reader 2: 60 minutes (n= 0,57)
    99999 ( 99999 )
    3.5 ( 1.3 )
        Reader 2: 90 minutes (n= 0,47)
    99999 ( 99999 )
    3.2 ( 1.4 )
        Reader 2: 120 minutes (n= 0,34)
    99999 ( 99999 )
    3.1 ( 1.4 )
        Reader 2: 150 minutes (n= 0,24)
    99999 ( 99999 )
    3.1 ( 1.4 )
        Reader 2: 180 minutes (n= 0,17)
    99999 ( 99999 )
    3.0 ( 1.4 )
        Reader 2: 210 minutes (n= 0,8)
    99999 ( 99999 )
    3.1 ( 1.6 )
        Reader 2: 240 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        Reader 2: 270 minutes (n= 0,4)
    99999 ( 99999 )
    3.3 ( 2.1 )
        Reader 2: 300 minutes (n= 0,1)
    99999 ( 99999 )
    4.0 ( 99999 )
        Reader 2: 330 minutes (n= 0,1)
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 2: 450 minutes (n= 0,0)
    99999 ( 99999 )
    99999 ( 99999 )
        Reader 2: 480 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        Reader 3: 30 minutes (n= 94,94)
    2.1 ( 1.3 )
    3.3 ( 1.3 )
        Reader 3: 60 minutes (n= 0,57)
    99999 ( 99999 )
    3.5 ( 1.2 )
        Reader 3: 90 minutes (n= 0,47)
    99999 ( 99999 )
    3.4 ( 1.3 )
        Reader 3: 120 minutes (n= 0,34)
    99999 ( 99999 )
    3.3 ( 1.3 )
        Reader 3: 150 minutes (n= 0,24)
    99999 ( 99999 )
    3.3 ( 1.4 )
        Reader 3: 180 minutes (n= 0,17)
    99999 ( 99999 )
    3.4 ( 1.4 )
        Reader 3: 210 minutes (n= 0,8)
    99999 ( 99999 )
    3.3 ( 1.6 )
        Reader 3: 240 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 3: 270 minutes (n= 0,4)
    99999 ( 99999 )
    3.8 ( 1.9 )
        Reader 3: 300 minutes (n= 0,1)
    99999 ( 99999 )
    3.0 ( 99999 )
        Reader 3: 330 minutes (n= 0,1)
    99999 ( 99999 )
    2.0 ( 99999 )
        Reader 3: 450 minutes (n= 0,0)
    99999 ( 99999 )
    99999 ( 99999 )
        Reader 3: 480 minutes (n= 0,1)
    99999 ( 99999 )
    1.0 ( 99999 )
        Reader 4: 30 minutes (n= 94,94)
    2.2 ( 1.2 )
    4.4 ( 1.3 )
        Reader 4: 60 minutes (n= 0,57)
    99999 ( 99999 )
    4.5 ( 1.2 )
        Reader 4: 90 minutes (n= 0,47)
    99999 ( 99999 )
    4.6 ( 0.9 )
        Reader 4: 120 minutes (n= 0,34)
    99999 ( 99999 )
    4.4 ( 1.0 )
        Reader 4: 150 minutes (n= 0,24)
    99999 ( 99999 )
    4.7 ( 0.7 )
        Reader 4: 180 minutes (n= 0,17)
    99999 ( 99999 )
    4.3 ( 1.0 )
        Reader 4: 210 minutes (n= 0,8)
    99999 ( 99999 )
    4.1 ( 1.1 )
        Reader 4: 240 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4: 270 minutes (n= 0,4)
    99999 ( 99999 )
    4.0 ( 1.4 )
        Reader 4: 300 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4: 330 minutes (n= 0,1)
    99999 ( 99999 )
    5.0 ( 99999 )
        Reader 4: 450 minutes (n= 0,0)
    99999 ( 99999 )
    99999 ( 99999 )
        Reader 4: 480 minutes (n= 0,1)
    99999 ( 99999 )
    2.0 ( 99999 )
    Statistical analysis title
    		 Statistical analysis 1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [47]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [47] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [48]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [48] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between NIR-F scores at each time point and the 30-min WL score of the index ureter (left or right) for each participant.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [49]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1
    Notes
    [49] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [All Participants]

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    End point title
    		 BICR Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery [All Participants]
    End point description
    BICR’s conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3=sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. mITT for all cohorts in WL/NIR-F arm. 99999 denotes NA, as no participants were evaluable.
    End point type
    Secondary
    End point timeframe
    WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)
    End point values
    		 All Participants: WL/NIR-F (Only WL) All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects analysed
    94
    94
    Units: score on a scale
    arithmetic mean (standard deviation)
        Reader 2: 30 minutes (n= 94,0)
    1.6 ( 0.9 )
    99999 ( 99999 )
        Reader 2: End of surgery (Day 1) (n= 0,94)
    99999 ( 99999 )
    3.0 ( 1.4 )
        Reader 3: 30 minutes (n= 94,0)
    2.1 ( 1.3 )
    99999 ( 99999 )
        Reader 3: End of surgery (Day 1) (n= 0,94)
    99999 ( 99999 )
    3.1 ( 1.4 )
        Reader 4: 30 minutes (n= 94,0)
    2.2 ( 1.2 )
    99999 ( 99999 )
        Reader 4: End of surgery (Day 1) (n= 0,94)
    99999 ( 99999 )
    4.1 ( 1.4 )
    Statistical analysis title
    		 Statistical analysis1, For reader 2
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [50]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [50] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 3, For reader 4
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [51]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [51] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.
    Statistical analysis title
    		 Statistical analysis 2, For reader 3
    Statistical analysis description
    Mean Difference was calculated by averaging over the differences between WL score at 30-min time point and the NIR-F score at the end of surgery across all participants.
    Comparison groups
    All Participants: WL/NIR-F (Only WL) v All Participants: WL/NIR-F (Only NIR-F)
    Number of subjects included in analysis
    188
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [52]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -99999
         upper limit
    		 99999
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Notes
    [52] - SAP pre-specified that 95% Confidence Interval would not be analyzed for this endpoint, 2-Sides (-99999, 99999) was entered to remove validation error.

    Secondary: Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    		 Number of participants with Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an Investigational Product(IP) and which does not necessarily had a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether considered related to the IP. A TEAE was defined as an AE with onset at any time from first dosing until the follow up period. AEs were considered serious (SAEs) if the AE resulted, in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. SAF population
    End point type
    Secondary
    End point timeframe
    From first dose up to 17 months and 15 days
    End point values
    		 Adult(Normal/Mild):White Light/near-infraredfluorescence Adult(Normal/Mild):White Light only Adult (Moderate):White Light/near-infraredfluorescence Adolescent(Normal/Mild):White Light/near-infraredfluorescence
    Number of subjects analysed
    70
    13
    8
    14
    Units: participants
    number (not applicable)
        TEAE
    28
    8
    1
    7
        Serious TEAE
    8
    4
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK) of pudexacianinium chloride: Plasma Concentration

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    End point title
    		 Pharmacokinetics (PK) of pudexacianinium chloride: Plasma Concentration
    End point description
    Concentration of pudexacianinium chloride in plasma. Pharmacokinetic Analysis Set (PKAS): All participants in any cohort who received pudexacianinium chloride for which at least 1 plasma or urine concentration data was available with the time for dosing and sampling. PKAS with available data was analyzed. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. 99999 denotes NA as only 1 participant analyzed thus SD was not evaluable or less than 3 participants were evaluated and as planned SD was not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 1 Postdose: 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390, 360 minutes
    End point values
    		 Adult(Normal/Mild):WL/NIR-F Adult(Normal/Mild):White Light only Adult (Moderate):White Light/Near-infraredfluorescence Adolescent(Normal/Mild):White Light/Near-infraredfluorescence
    Number of subjects analysed
    62
    13
    8
    14
    Units: nanogram/milliliters (ng/mL)
    arithmetic mean (standard deviation)
        10 minutes (n= 13,62,8,14)
    411 ( 387 )
    366 ( 109 )
    426 ( 137 )
    410 ( 141 )
        30 minutes (n= 13,61,8,14)
    185 ( 46.8 )
    197 ( 61.2 )
    267 ( 93.6 )
    244 ( 86.4 )
        60 minutes (n= 11,59,8,12,)
    126 ( 36.1 )
    129 ( 34.4 )
    203 ( 56.8 )
    166 ( 50.1 )
        90 minutes (n= 7,30,5,9)
    108 ( 34.6 )
    111 ( 40.5 )
    172 ( 42.3 )
    121 ( 46.1 )
        120 minutes (n= 8,45,6,8)
    79.8 ( 30.3 )
    78.3 ( 37.1 )
    147 ( 44.7 )
    99.2 ( 26.8 )
        150 minutes (n= 3,21,4,2)
    82.8 ( 29.0 )
    115 ( 37.3 )
    128 ( 25.1 )
    120 ( 99999 )
        180 minutes (n= 6,20,2,3)
    61.9 ( 24.8 )
    59.2 ( 24.1 )
    128 ( 99999 )
    47.1 ( 17.5 )
        210 minutes (n= 2,5,1,0)
    53.8 ( 16.0 )
    47.8 ( 99999 )
    97.6 ( 99999 )
    99999 ( 99999 )
        240 minutes (n= 1,5,0,0)
    69.7 ( 28.5 )
    45.8 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        270 minutes (n= 0,2,01)
    42.4 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    34.2 ( 99999 )
        300 minutes (n= 1,3,0,0)
    51.1 ( 18.7 )
    30.9 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        330 minutes (n= 0,1,0,0)
    25.6 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        360 minutes (n= 0,1,0,0)
    22.4 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        390 minutes (n= 0,2,0,0)
    28.9 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: PK of pudexacianinium chloride: Urine Concentration

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    End point title
    		 PK of pudexacianinium chloride: Urine Concentration
    End point description
    Concentration of pudexacianinium chloride in urine. PKAS with available data was analyzed. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. 99999 denotes NA as only 1 participant analyzed thus SD was not evaluable or less than 3 participants were evaluated and as planned SD was not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300,300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes
    End point values
    		 Adult(Normal/Mild):WL/NIR-F Adult(Normal/Mild):White Light only Adult (Moderate):White Light/Near-infraredfluorescence Adolescent(Normal/Mild):White Light/Near-infraredfluorescence
    Number of subjects analysed
    56
    11
    8
    13
    Units: ng/mL
    arithmetic mean (standard deviation)
        0-10 minutes (n= 11,56,8,9)
    235 ( 629 )
    1530 ( 4100 )
    80.4 ( 165 )
    9.98 ( 29.9 )
        10-30 minutes (n= 10,51,4,13)
    10200 ( 15600 )
    4960 ( 6050 )
    7890 ( 3610 )
    14200 ( 15100 )
        30-60 minutes (n= 9,52,3,13)
    19800 ( 20300 )
    18000 ( 18600 )
    10400 ( 6640 )
    25200 ( 22000 )
        60-90 minutes (n= 8,47,6,7)
    20100 ( 21200 )
    16700 ( 18100 )
    25500 ( 17100 )
    41600 ( 41900 )
        90-120 minutes (n= 5,35,5,5)
    14500 ( 9630 )
    17700 ( 13300 )
    25800 ( 37200 )
    49800 ( 62000 )
        120-150 minutes (n= 5,24,2,5)
    10700 ( 6880 )
    20700 ( 8850 )
    17400 ( 99999 )
    25500 ( 16600 )
        150-180 minutes (n= 5,22,1,2)
    9110 ( 6530 )
    17900 ( 7900 )
    18400 ( 99999 )
    19600 ( 99999 )
        180-210 minutes (n= 1,5,0,1)
    8690 ( 6920 )
    6230 ( 99999 )
    99999 ( 99999 )
    10500 ( 99999 )
        210-240 minutes (n= 1,4,0,1)
    5750 ( 2310 )
    5230 ( 99999 )
    99999 ( 99999 )
    6500 ( 99999 )
        240-270 minutes (n= 0,2,0,0)
    5500 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        270-300 minutes (n= 0,3,0,0)
    3690 ( 1600 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        300-330 minutes (n= 0,2,0,0)
    4860 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        330-360 minutes (n= 0,3,0,0)
    3630 ( 2680 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        360,390 minutes (n= 0,3,0,0)
    2650 ( 1640 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        390-420 minutes (n= 0,3,0,0)
    1570 ( 2400 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        420-450 minutes (n= 0,2,0,0)
    3150 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        450-480 minutes (n= 0,1,0,0)
    3070 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Amount of pudexacianinium chloride excreted into urine (Ae)

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    End point title
    		 Amount of pudexacianinium chloride excreted into urine (Ae)
    End point description
    PKAS with available data was analyzed. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. 99999 denotes NA as only 1 participant analyzed thus SD was not evaluable or less than 3 participants were evaluated and as planned SD was not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300,300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes
    End point values
    		 Adult(Normal/Mild):WL/NIR-F Adult(Normal/Mild):White Light only Adult (Moderate):White Light/Near-infraredfluorescence Adolescent(Normal/Mild):White Light/Near-infraredfluorescence
    Number of subjects analysed
    56
    10
    8
    13
    Units: milligrams
    arithmetic mean (standard deviation)
        0-10 minutes (n= 10,56,8,9)
    0.0190 ( 0.0425 )
    0.0443 ( 0.0790 )
    0.000713 ( 0.0194 )
    0.000657 ( 0.00197 )
        10-30 minutes (n= 9,51,4,13)
    0.164 ( 0.198 )
    0.0773 ( 0.122 )
    0.122 ( 0.0759 )
    0.245 ( 0.269 )
        30-60 minutes (n= 9,52,3,13)
    0.274 ( 0.230 )
    0.375 ( 0.276 )
    0.175 ( 0.0305 )
    0.240 ( 0.258 )
        60-90 minutes (n= 8,48,6,7)
    0.340 ( 0.232 )
    0.304 ( 0.290 )
    0.216 ( 0.160 )
    0.348 ( 0.417 )
        90-120 minutes (n= 5,36,5,5)
    0.306 ( 0.199 )
    0.325 ( 0.261 )
    0.151 ( 0.0570 )
    0.578 ( 0.465 )
        120-150 minutes (n= 5,24,2,5)
    0.203 ( 0.131 )
    0.301 ( 0.112 )
    0.0511 ( 99999 )
    0.256 ( 0.170 )
        150-180 minutes (n= 5,22,1,2)
    0.143 ( 0.0859 )
    0.286 ( 0.289 )
    0.171 ( 99999 )
    0.450 ( 99999 )
        180-210 minutes (n= 1,5,0,1)
    0.151 ( 0.0763 )
    0.147 ( 99999 )
    99999 ( 99999 )
    0.162 ( 99999 )
        210-240 minutes (n= 1,4,0,2)
    0.0937 ( 0.0307 )
    0.175 ( 99999 )
    99999 ( 99999 )
    0.0702 ( 99999 )
        240-270 minutes (n= 0,2,0,0)
    0.0803 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        270-300 minutes (n= 0,3,0,0)
    0.0655 ( 0.0105 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        300-330 minutes (n= 0,2,0,0)
    0.0582 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        330-360 minutes(n= 0,3,0,0)
    0.0438 ( 0.0541 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        360-390 minutes (n= 0,3,0,0)
    0.0808 ( 0.0412 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        390-420 minutes (n= 0,3,0,0)
    0.0263 ( 0.0209 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        420-450 minutes(n= 0,2,0,0)
    0.0835 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        450-480 minutes(n= 0,1,0,0)
    0.0301 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Percentage of pudexacianinium chloride dose excreted into urine (Ae%)

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    End point title
    		 Percentage of pudexacianinium chloride dose excreted into urine (Ae%)
    End point description
    PKAS with available data was analyzed. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. 99999 denotes NA as only 1 participant analyzed thus SD was not evaluable or less than 3 participants were evaluated and as planned SD was not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300,300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes
    End point values
    		 Adult(Normal/Mild):WL/NIR-F Adult(Normal/Mild):White Light only Adult (Moderate):White Light/Near-infraredfluorescence Adolescent(Normal/Mild):White Light/Near-infraredfluorescence
    Number of subjects analysed
    56
    10
    8
    13
    Units: percentage of drug excreted
    arithmetic mean (standard deviation)
        0-10 minutes (n= 10,56,8,9)
    0.633 ( 1.42 )
    1.48 ( 2.63 )
    0.238 ( 0.646 )
    0.0219 ( 0.0657 )
        10-30 minutes (n=9,51,4,13)
    5.46 ( 6.59 )
    2.58 ( 4.06 )
    4.06 ( 2.53 )
    8.18 ( 8.98 )
        30-60 minutes (n= 9,52,3,13)
    9.15 ( 7.68 )
    12.5 ( 9.21 )
    5.83 ( 1.02 )
    7.99 ( 8.59 )
        60-90 minutes (n= 8,48,6,7)
    11.3 ( 7.74 )
    10.1 ( 9.66 )
    7.20 ( 5.32 )
    11.6 ( 13.9 )
        90-120 minutes (n= 5,36,5,5)
    10.2 ( 6.63 )
    10.8 ( 8.71 )
    5.03 ( 1.90 )
    19.3 ( 15.5 )
        120-150 minutes (n= 5,24,2,5)
    6.77 ( 4.38 )
    10.0 ( 3.74 )
    1.70 ( 99999 )
    8.54 ( 5.68 )
        150-180 minutes (n= 5,22,1,2)
    4.78 ( 2.86 )
    9.52 ( 9.62 )
    5.70 ( 99999 )
    15.0 ( 99999 )
        180-210 minutes (n= 1,5,0,1)
    5.03 ( 2.54 )
    4.90 ( 99999 )
    99999 ( 99999 )
    5.39 ( 99999 )
        210-240 minutes (n= 1,4,0,1)
    3.12 ( 1.02 )
    5.82 ( 99999 )
    99999 ( 99999 )
    2.34 ( 99999 )
        240-270 minutes (n= 0,2,0,0)
    2.68 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        270-300 minutes (n= 0,3,0,0)
    2.18 ( 0.351 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        300-330 minutes (n= 0,2,0,0)
    1.94 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        330-360 minutes (n= 0,3,0,0)
    1.46 ( 1.80 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        360,390 minutes (n= 0,3,0,0)
    2.69 ( 1.37 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        390-420 minutes (n= 0,3,0,0)
    0.877 ( 0.697 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        420-450 minutes (n= 0,2,0,0)
    2.78 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
        450-480 minutes (n= 0,1,0,0)
    1.00 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality (ACM): From randomization up to 17 months and 15 days Adverse events: From first dose up to 17 months and 15 days
    Adverse event reporting additional description
    ACM was analyzed for all randomized population. Serious and Non serious adverse events: SAF
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v27.0
    Reporting groups
    Reporting group title
    Adult (Normal/Mild): White Light/near-infrared fluorescence
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Reporting group title
    Adolescent (Normal/Mild): WL/NIR-F
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Reporting group title
    Adult (Moderate): White Light/near-infrared fluorescence
    Reporting group description
    		 Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter.

    Reporting group title
    Adult (Normal/Mild): White Light only
    Reporting group description
    		 Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL was used to recognize/identify the ureter.

    Serious adverse events
    		 Adult (Normal/Mild): White Light/near-infrared fluorescence Adolescent (Normal/Mild): WL/NIR-F Adult (Moderate): White Light/near-infrared fluorescence Adult (Normal/Mild): White Light only
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 70 (11.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    4 / 13 (30.77%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Postoperative ileus
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic haematoma
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic haemorrhage
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis aspiration
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary tract obstruction
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adult (Normal/Mild): White Light/near-infrared fluorescence Adolescent (Normal/Mild): WL/NIR-F Adult (Moderate): White Light/near-infrared fluorescence Adult (Normal/Mild): White Light only
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 70 (15.71%)
    7 / 14 (50.00%)
    1 / 8 (12.50%)
    5 / 13 (38.46%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 70 (2.86%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 70 (5.71%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Dilutional anaemia
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 70 (4.29%)
    0 / 14 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    2 / 70 (2.86%)
    5 / 14 (35.71%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    5
    0
    0
    Loss of bladder sensation
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Postoperative wound infection
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 14 (7.14%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 70 (0.00%)
    0 / 14 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2023
    • The protocol design is updated to include adult participants with moderate or severe renal impairment. Impacted language includes: • Primary and Key Secondary Objectives and endpoints • New additional secondary objective/endpoints are added • Primary estimands • Number of participants • Study Design Overview o Adult participants will now include a normal/mild eGFR cohort with randomization to the NIR-F/WL arm and a WL-only arm (investigator blinded), and a moderate/severe eGFR cohort with conspicuity assessed with NIR-F and WL at all time points o Adolescent cohort remains the same • Inclusion criterion no. 4 regarding eGFR criteria is updated • A new exclusion criterion is added for participants on hemodialysis, hemodiafiltration or peritoneal dialysis. • Assignment of study intervention • Statistical considerations • The eGFR formula for adolescents is changed to Schwartz formula. • Clarification for the timing of the first conspicuity assessment. Study design details for the investigator’s selection of ureter(s) is updated.
    02 Oct 2023
    • Details for the addition of a blinded independent central review (BICR) are added. Notable updates include: new secondary objectives and endpoints, details on the timing and instructions on how to perform the new efficacy assessment and details on how the analysis of the secondary endpoints will be performed. • The number of participants in the moderate/severe eGFR cohort is increased from up to 7 to up to 10, with the total number of participants being updated from 104 to 107. • The rescreening language is updated.
    04 Apr 2024
    • Additional endpoints for the BICR additional secondary objective are added. The statistical analysis details for the new endpoints are added. • The visit window is updated from ± 5 days to ± 10 days. As a result, the anticipated duration of the study for each participant is updated from 5 to 43 days to 5 to 53 days. • The blood and urine sample collection schedule for pharmacokinetics is updated. The following language is updated in the key secondary endpoints: Descriptive statistics will be used to summarize the ureter conspicuity at the 30-min time point after ASP5354 administration with WL and the end of surgery time point with NIR-F. The same imputation algorithm described in the analysis of the first key secondary endpoint will be applied to the data prior to setting the end of surgery NIR-F value for each particiant.
    24 Oct 2024
    And other Non substantial amendments.

    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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