A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05754333

Enrollment

107

Registered

2023-03-03

Start date

2023-08-02

Completion date

2025-01-16

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominolpelvic Surgery, Intraoperative Ureter Visualization

Keywords

ASP5354, pudexacianinium chloride, Iatrogenic ureteral injury, Abdominopelvic surgery, Near infrared fluorescence

Brief summary

The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This study was about a potential new medical dye, called ASP5354. This dye was injected into the person at the start of surgery and was detected in the ureter. This was done by an imaging machine which had an option called near infrared fluorescence, or NIR-F. Together they showed live images of specific parts of the body. In this study, ASP5354 was used with an imaging machine with a NIR-F option to show live images of the ureter during surgery. People with kidneys that work properly and those with kidney problems could take part. The main aim of the study was to find out how clearly the ureter could be seen with ASP5354 during surgery in adults whose kidneys work properly or who have mild kidney problems. To do this, the surgeons injected ASP5354 into the person having surgery. Then, the surgeons compared images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light was the standard way surgeons see the ureter during surgery. People 12 years or older who were going to have certain abdominal surgeries could take part. Everyone taking part received ASP5354 during surgery, but how the imaging was done depended on which group they are in. Before surgery, the adults taking part whose kidneys work properly or who have mild kidney problems were assigned into 1 of 2 groups by chance alone. Images of the ureter were checked in 1 group using normal white light and the other group using normal white light and NIR-F. People 18 years and older with more severe kidney problems and all people under 18 years old were not be assigned to 1 of 2 groups: all images of the ureter were checked using normal white light and NIR-F. At the start of surgery, the surgeon injected ASP5354 into the person having surgery, then started recording a video. Then, after 30 minutes, the surgeon recorded how well the ureter could be seen. This was done by either using normal white light, or normal white light and NIR-F, depending which group each person having surgery was assigned to. For the group to be checked with normal white light and NIR-F, the surgeon did this every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon did this after the first 30 minutes. During the study, people visited the study hospital 3 times. The first visit was to check if they can take part in the study. People were asked about their medical history, have had a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they had some blood and urine tests. For women and girls this may included a pregnancy test. People had their surgery at the second visit. This was within 28 days of their first visit. This included having some blood and urine tests before, during, and after surgery. Also, they had a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and had their vital signs checked. After surgery, people returned to the clinic 15 days later for a final check-up. They were asked if they have had any medical problems. Also, they had a medical examination, had their vital signs checked, and had some blood and urine tests.

Interventions

DRUGpudexacianinium chloride

Intravenous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participant is scheduled to undergo minimally invasive or open abdominopelvic surgery that may require ureter(s) identification. * Participant has normal renal function or has varying degrees of chronic kidney disease as defined by the National Kidney Foundation and calculated by individual eGFR using the modification of diet in renal disease (MDRD) formula for adults or the Schwartz formula for adolescents at the screening visit. * Adult normal/mild eGFR cohort: eGFR ≥ 60 mL/min * Adult moderate/severe eGFR cohort: eGFR ≥ 15 to \< 60 mL/min * Adolescent cohort: eGFR ≥ 60 mL/min * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of childbearing potential (WOCBP). * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration. * Female participant must agree not to breastfeed starting at the administration of ASP5354 through 30 days after ASP5354 administration. * Female participant must not donate ova starting at the administration of ASP5354 through 30 days after ASP5354 administration. * Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception through at least 30 days after ASP5354 administration. * Male participant must not donate sperm starting at the administration of ASP5354 through 30 days after ASP5354 administration. * Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy from the start of ASP5354 administration through 30 days after ASP5354 administration. * Participant (and/or participant's parent or legal guardian) agrees not to participate in another interventional study involving unapproved study medication while participating in the present study.

Exclusion criteria

* Participant has any physical or psychiatric condition which makes the participant unsuitable for study participation. * Participant is anticipated to require ureteral stenting during surgery. * Participant has an active urinary tract infection requiring antibiotic therapy. * Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance. * Participant has any clinically relevant laboratory abnormality that could contraindicate surgery. * Participant with body weight \< 30 kilogram (kg). * Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used. * Participant has had previous exposure to ASP5354. * Participant has been administered ICG or other near-infrared fluorescent (NIR-F) imaging agents within 48 hours prior to ASP5354 administration, with the exception of participants who receive ICG for lymphatic mapping before the surgery. * Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to randomization. * Participant is on hemodialysis, hemodiafiltration or peritoneal dialysis

Design outcomes

Primary

Measure	Time frame	Description
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Normal/Mild): WL/NIR-F]	30 minutes post dose (+/- 15 minutes)	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.

Secondary

Measure	Time frame	Description
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Normal/Mild): WL/NIR-F]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]	From first dose every 30 minutes thereafter up to end of surgery (Day 1)	UC was quantified by image analysis when pudexacianinium was present in ureter. Contrast enhancement factor (CEF) was measure of degree to which color contrast (CC) was enhanced in areas in which drug fluorescence signal was present. Images of ureters during surgery were decomposed into red (R), green (G) & blue (B) using Image analysis software. R, G & B video components corresponding to each full color image were exported as 256 shades of gray, ranging from pure black (0) to pure white (255). CC between dye fluorescence in ureter & surrounding tissues was quantified by calculating ratio of signal levels G/(R + B). A higher CEF score=higher (green) contrast in ureter compared to the surrounding tissue. A commensurate ratio value was calculated for signals emanating from tissues surrounding ureter lumen. A comparison of ratio values was expressed as a CEF = (G/(R + B)inside)/(G/(R + B)outside. Overall average data of each time point from first dose up to end of surgery was reported.
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F]	30 minutes post dose (+/- 15 minutes)	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.
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]	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes	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.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	30 minutes post dose (+/- 15 minutes)	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.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes	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.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	30 minutes post dose (+/- 15 minutes)	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.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes	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.
Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	WL and NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes	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. Difference in average index ureter conspicuity scores between NIR-F & WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 1, 2, 3 and 4 points higher.
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	30 minutes post dose (+/- 15 minutes)	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.
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	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes	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 is concordance correlation coefficient, & it measures agreement between investigator and BICR reader for value difference between WL at 30-mintimepoint & 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 is reported in Outcome measure #2.
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]	WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes	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.
BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	30 minutes post dose (+/- 15 minutes)	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.
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]	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes	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.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	30 minutes post dose (+/- 15 minutes)	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.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes	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.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	30 minutes post dose (+/- 15 minutes)	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.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes	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.
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	From first dose up to 15 days (+ 10 days)	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. TEAEs included both serious and Other (Not Including Serious) TEAE.
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	Day 1 Postdose: 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390, 360 minutes	Concentration of pudexacianinium chloride in plasma. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.
PK of Pudexacianinium Chloride: Urine Concentration	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	Concentration of pudexacianinium chloride in urine.PK samples were collected up to the end of surgery timepoint of each participant. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	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	PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	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	PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.
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	WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)	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 is concordance correlation coefficient, and it measures 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 Reader 2, 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.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment 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

Participants by arm

Arm	Count
Adult (Normal/Mild): White Light/Near-infrared Fluorescence 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.	70
Adult (Normal/Mild): White Light Only 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.	13
Adult (Moderate): White Light/Near-infrared Fluorescence 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.	8
Adolescent (Normal/Mild): WL/NIR-F 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.	14
Total	105

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	2	1	0	1
Overall Study	Miscellaneous	3	0	0	0

Baseline characteristics

Characteristic	Adult (Normal/Mild): White Light/Near-infrared Fluorescence	Total	Adolescent (Normal/Mild): WL/NIR-F	Adult (Moderate): White Light/Near-infrared Fluorescence	Adult (Normal/Mild): White Light Only
Age, Continuous	54.5 Years STANDARD_DEVIATION 15	49.9 Years STANDARD_DEVIATION 20.6	14.4 Years STANDARD_DEVIATION 1.7	70.3 Years STANDARD_DEVIATION 8.6	52.2 Years STANDARD_DEVIATION 21.6
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	18 Participants	4 Participants	2 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants	85 Participants	10 Participants	6 Participants	12 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	5 Participants	7 Participants	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	9 Participants	12 Participants	1 Participants	0 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants	5 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	51 Participants	81 Participants	12 Participants	7 Participants	11 Participants
Sex: Female, Male Female	48 Participants	72 Participants	8 Participants	6 Participants	10 Participants
Sex: Female, Male Male	22 Participants	33 Participants	6 Participants	2 Participants	3 Participants
Type of Surgery (Gynecological & Other-Abdominopelvic) Gynecological	15 Participants	24 Participants	7 Participants	0 Participants	2 Participants
Type of Surgery (Gynecological & Other-Abdominopelvic) Other- Abdominopelvic	55 Participants	81 Participants	7 Participants	8 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 72	0 / 13	0 / 8	0 / 14
other Total, other adverse events	11 / 70	5 / 13	1 / 8	7 / 14
serious Total, serious adverse events	8 / 70	4 / 13	0 / 8	0 / 14

Outcome results

Primary

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

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: ITT

Arm	Measure	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Normal/Mild): WL/NIR-F]	2.7 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Normal/Mild): WL/NIR-F]	4.3 score on a scale	Standard Deviation 1.2

p-value: <0.00195% CI: [1.2, 1.9]paired t Test

Secondary

Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)

PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.

Time frame: 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

Population: PKAS with available data was analyzed. Since participants had different end of surgery timepoint, number of observations were different by Arm/Group as the last observation timepoint is different by participant.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	120-150 minutes	0.301 milligrams	Standard Deviation 0.112
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	60-90 minutes	0.304 milligrams	Standard Deviation 0.29
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	30-60 minutes	0.375 milligrams	Standard Deviation 0.276
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	90-120 minutes	0.325 milligrams	Standard Deviation 0.261
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	180-210 minutes	0.147 milligrams	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	0-10 minutes	0.0443 milligrams	Standard Deviation 0.079
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	10-30 minutes	0.0773 milligrams	Standard Deviation 0.122
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	210-240 minutes	0.175 milligrams	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	150-180 minutes	0.286 milligrams	Standard Deviation 0.289
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	450- 480 minutes	0.0301 milligrams	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	10-30 minutes	0.164 milligrams	Standard Deviation 0.198
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	0-10 minutes	0.0190 milligrams	Standard Deviation 0.0425
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	30-60 minutes	0.274 milligrams	Standard Deviation 0.23
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	60-90 minutes	0.340 milligrams	Standard Deviation 0.232
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	90-120 minutes	0.306 milligrams	Standard Deviation 0.199
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	120-150 minutes	0.203 milligrams	Standard Deviation 0.131
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	150-180 minutes	0.143 milligrams	Standard Deviation 0.0859
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	180-210 minutes	0.151 milligrams	Standard Deviation 0.0763
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	210-240 minutes	0.0937 milligrams	Standard Deviation 0.0307
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	240-270 minutes	0.0803 milligrams	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	270- 300 minutes	0.0655 milligrams	Standard Deviation 0.0105
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	300- 330 minutes	0.0582 milligrams	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	330- 360 minutes	0.0438 milligrams	Standard Deviation 0.0541
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	360-390 minutes	0.0808 milligrams	Standard Deviation 0.0412
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	390-420 minutes	0.0263 milligrams	Standard Deviation 0.0209
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	420-450 minutes	0.0835 milligrams	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	90-120 minutes	0.151 milligrams	Standard Deviation 0.057
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	150-180 minutes	0.171 milligrams	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	10-30 minutes	0.122 milligrams	Standard Deviation 0.0759
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	0-10 minutes	0.00713 milligrams	Standard Deviation 0.0194
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	120-150 minutes	0.0511 milligrams	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	60-90 minutes	0.216 milligrams	Standard Deviation 0.16
Adult (Moderate): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	30-60 minutes	0.175 milligrams	Standard Deviation 0.0305
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	120-150 minutes	0.256 milligrams	Standard Deviation 0.17
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	60-90 minutes	0.348 milligrams	Standard Deviation 0.417
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	0-10 minutes	0.000657 milligrams	Standard Deviation 0.00197
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	150-180 minutes	0.450 milligrams	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	30-60 minutes	0.240 milligrams	Standard Deviation 0.258
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	10-30 minutes	0.245 milligrams	Standard Deviation 0.269
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	210-240 minutes	0.0702 milligrams	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	180-210 minutes	0.162 milligrams	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)	90-120 minutes	0.578 milligrams	Standard Deviation 0.465

Secondary

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

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: mITT in adolescents

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	Reader 2	2.1 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	Reader 3	2.9 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	Reader 4	3.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	Reader 2	3.9 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	Reader 3	4.1 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F	Reader 4	4.8 score on a scale	Standard Deviation 0.6

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

Secondary

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

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: mITT in adults with moderate eGFR

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	Reader 2	1.3 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	Reader 3	1.5 score on a scale	Standard Deviation 0.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	Reader 4	2.0 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	Reader 3	2.4 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	Reader 2	2.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	Reader 4	4.1 score on a scale	Standard Deviation 1.4

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

Secondary

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

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: mITT for all cohorts in WL/NIR-F arm

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	Reader 2	1.6 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	Reader 3	2.1 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	Reader 4	2.2 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	Reader 2	3.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	Reader 3	3.3 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	Reader 4	4.4 score on a scale	Standard Deviation 1.3

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

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]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes

Population: mITT in adolescents with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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]	Reader 3: 30 minutes	2.9 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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]	Reader 4: 30 minutes	3.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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]	Reader 2: 30 minutes	2.1 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 90 minutes	3.8 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 120 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 150 minutes	2.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 180 minutes	3 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 210 minutes	1 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 30 minutes	4.1 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 60 minutes	3.4 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 90 minutes	3.8 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 120 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 150 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 180 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 3: 210 minutes	1.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 30 minutes	4.8 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 60 minutes	5.0 score on a scale	Standard Deviation 0
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 90 minutes	5.0 score on a scale	Standard Deviation 0
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 120 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 150 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 180 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 4: 210 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 30 minutes	3.9 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	Reader 2: 60 minutes	3.4 score on a scale	Standard Deviation 1.2

Comparison: Difference from WL in Means, Reader 2

Comparison: Difference from WL in Means, Reader 3

Comparison: Difference from WL in Means, Reader 4

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]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes

Population: mITT in adults with moderate eGFR with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 30 minutes	1.3 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 30 minutes	1.5 score on a scale	Standard Deviation 0.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 30 minutes	2.0 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 120 minutes	2.8 score on a scale	Standard Deviation 1.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 150 minutes	2.3 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 180 minutes	1 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 30 minutes	2.4 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 60 minutes	3.5 score on a scale	Standard Deviation 2.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 90 minutes	2.8 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 120 minutes	3.0 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 150 minutes	2.3 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 3: 180 minutes	2.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 30 minutes	4.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 60 minutes	4.5 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 90 minutes	5.0 score on a scale	Standard Deviation 0
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 120 minutes	3.8 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 150 minutes	4.7 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 30 minutes	2.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 4: 180 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 60 minutes	3.5 score on a scale	Standard Deviation 2.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	Reader 2: 90 minutes	2.8 score on a scale	Standard Deviation 1.5

Comparison: For reader 4

Comparison: For reader 2

Comparison: For reader 3

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

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 is concordance correlation coefficient, & it measures agreement between investigator and BICR reader for value difference between WL at 30-mintimepoint & 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 is reported in Outcome measure #2.

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes

Population: ITT with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	Reader 3, 30 minutes	2.1 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	Reader 2, 30 minutes	1.5 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	Reader 4, 30 minute	2.0 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 60 minutes	3.5 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 90 minutes	3.2 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 120 minutes	3.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 150 minutes	3.3 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 210 minutes	3.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 240 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 270 minutes	3.3 score on a scale	Standard Deviation 2.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 300 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 330 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 480 minutes	1.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 30 minutes	3.2 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 60 minutes	3.5 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 90 minutes	3.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 120 minutes	3.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 150 minutes	3.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 180 minutes	3.5 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 210 minutes	3.6 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 270 minutes	3.8 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 300 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 330 minutes	2 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 480 minutes	1 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 30 minute	4.3 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 60 minute	4.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 90 minute	4.5 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 120 minute	4.4 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 150 minute	4.7 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 180 minute	4.3 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 210 minute	4.3 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 240 minute	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 270 minute	4.0 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 300 minute	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 330 minute	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 180 minutes	3.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 4, 480 minute	2.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 3, 240 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	Reader 2, 30 minutes	3.4 score on a scale	Standard Deviation 1.4

Comparison: For reader 2p-value: <0.00195% CI: [1.4, 2]Sign test

Comparison: CCC between BICR and investigator (95% CI), Reader 295% CI: [-0.013, 0.429]

Comparison: For reader 3p-value: <0.00195% CI: [0.8, 1.4]Sign test

Comparison: CCC between BICR and investigator (95% CI), Reader 395% CI: [-0.191, 0.272]

Comparison: For reader 4p-value: <0.00195% CI: [1.8, 2.5]Sign test

Comparison: CCC between BICR and investigator (95% CI), Reader 495% CI: [0.014, 0.451]

Secondary

BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes

Population: mITT for all cohorts in WL/NIR-F arm with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 30 minutes	2.2 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 30 minutes	2.1 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 30 minutes	1.6 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 90 minutes	3.2 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 120 minutes	3.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 150 minutes	3.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 180 minutes	3.0 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 210 minutes	3.1 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 240 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 270 minutes	3.3 score on a scale	Standard Deviation 2.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 300 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 330 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 480 minutes	1.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 30 minutes	3.3 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 60 minutes	3.5 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 90 minutes	3.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 120 minutes	3.3 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 150 minutes	3.3 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 180 minutes	3.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 210 minutes	3.3 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 240 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 270 minutes	3.8 score on a scale	Standard Deviation 1.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 300 minutes	3.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 330 minutes	2.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 3: 480 minutes	1.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 30 minutes	4.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 60 minutes	4.5 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 90 minutes	4.6 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4:120 minutes	4.4 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 150 minutes	4.7 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 180 minutes	4.3 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 210 minutes	4.1 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 240 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 270 minutes	4.0 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 300 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 330 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 4: 480 minutes	2.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 30 minutes	3.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	Reader 2: 60 minutes	3.5 score on a scale	Standard Deviation 1.3

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

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]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: mITT in adolescents

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	Reader 2: 30 minutes	2.1 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	Reader 3: 30 minutes	2.9 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	Reader 4: 30 minutes	3.4 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	Reader 2: End of surgery (Day 1)	3.4 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	Reader 3: End of surgery (Day 1)	3.6 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	Reader 4: End of surgery (Day 1)	4.8 score on a scale	Standard Deviation 0.6

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

Secondary

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

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: mITT in adults with moderate eGFR

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	Reader 2: 30 minutes	1.3 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	Reader 3: 30 minutes	1.5 score on a scale	Standard Deviation 0.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	Reader 4: 30 minutes	2.0 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	Reader 2: End of Surgery (Day 1)	2.3 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	Reader 3: End of Surgery (Day 1)	2.6 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	Reader 4: End of Surgery (Day 1)	4.0 score on a scale	Standard Deviation 1.1

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

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

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 is concordance correlation coefficient, and it measures 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 Reader 2, 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.

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: ITT

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	READER 2, 30 minutes	1.5 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	READER 3, 30 minutes	2.1 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	READER 4, 30 minutes	2.0 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	READER 2 End of surgery (Day 1)	3.0 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	READER 3, End of surgery (Day 1)	3.0 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	READER 4, End of surgery (Day 1)	4.0 score on a scale	Standard Deviation 1.5

Comparison: For reader 2p-value: <0.00195% CI: [1.1, 1.8]paired t test

Comparison: CCC between BICR and investigator (95% CI), Reader 295% CI: [0.116, 0.529]

Comparison: For reader 3p-value: <0.00195% CI: [0.6, 1.3]paired t test

Comparison: CCC between BICR and investigator (95% CI), Reader 395% CI: [-0.048, 0.4]

Comparison: For reader 4p-value: <0.00195% CI: [1.6, 2.3]paired t test

Comparison: CCC between BICR and investigator (95% CI), Reader 495% CI: [0.07, 0.495]

Secondary

BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: mITT for all cohorts in WL/NIR-F arm

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	Reader 4: 30 minutes	2.2 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	Reader 2: 30 minutes	1.6 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	Reader 3: 30 minutes	2.1 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	Reader 4: End of surgery (Day 1)	4.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	Reader 3: End of surgery (Day 1)	3.1 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	Reader 2: End of surgery (Day 1)	3.0 score on a scale	Standard Deviation 1.4

Comparison: For reader 2

Comparison: For reader 3

Comparison: For reader 4

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

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.

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: ITT

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	READER 3	2.1 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	READER 2	1.5 score on a scale	Standard Deviation 0.9
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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	READER 4	2.0 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	READER 2	3.4 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	READER 3	3.2 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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	READER 4	4.3 score on a scale	Standard Deviation 1.4

Comparison: For reader 2p-value: <0.00195% CI: [1.6, 2.2]paired t test

Comparison: CCC between BICR and investigator (95% CI), Reader 295% CI: [-0.011, 0.431]

Comparison: For reader 3p-value: <0.00195% CI: [0.8, 1.5]paired t test

Comparison: CCC between BICR and investigator (95% CI), Reader 395% CI: [-0.181, 0.282]

Comparison: For reader 4p-value: <0.00195% CI: [1.9, 2.6]paired t test

Comparison: CCC between BICR and investigator (95% CI), Reader 495% CI: [0.03, 0.464]

Secondary

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

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: Modified Intent to Treat (mITT): All adolescent participants in the WL/NIR-F arm

Arm	Measure	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F]	3.5 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F]	4.4 score on a scale	Standard Deviation 1.2

Secondary

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

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: mITT in adults with moderate eGFR in the WL/NIR-F arm.

Arm	Measure	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	1.4 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F]	2.9 score on a scale	Standard Deviation 1.1

Secondary

Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]

Time frame: 30 minutes post dose (+/- 15 minutes)

Population: mITT that included all participants in any cohort in the WL/NIR-F arm.

Arm	Measure	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	2.7 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]	4.2 score on a scale	Standard Deviation 1.2

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]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes

Population: mITT in adolescents with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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]	30 minutes	3.5 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	30 minutes	4.4 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	60 minutes	4.5 score on a scale	Standard Deviation 0.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	90 minutes	4.5 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	120 minutes	5.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	150 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	180 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	210 minutes	2.0 score on a scale	—

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]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes

Population: mITT in adults with moderate eGFR with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	30 minutes	1.4 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	90 minutes	3.2 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	30 minutes	2.9 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	60 minutes	4.2 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	120 minutes	3.8 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	150 minutes	2.7 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]	180 minutes	2.0 score on a scale	—

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]

Time frame: WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes

Population: ITT with available data was analyzed

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	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]	30 minutes	2.7 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	480 minutes	4.0 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	30 minutes	4.3 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	60 minutes	4.3 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	120 minutes	4.2 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	150 minutes	3.8 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	180 minutes	3.8 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	210 minutes	3.9 score on a scale	Standard Deviation 1.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	240 minutes	4.7 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	270 minutes	4.5 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	300 minutes	5.0 score on a scale	Standard Deviation 0
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	330 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	90 minutes	4.2 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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]	450 minutes	1.0 score on a scale	—

p-value: <0.00195% CI: [1.2, 1.8]Sign test

Secondary

Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]

Time frame: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes

Population: mITT for all cohorts in WL/NIR-F arm with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	30 minutes	2.7 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	30 minutes	4.2 score on a scale	Standard Deviation 1.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	180 minutes	3.7 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	300 minutes	5.0 score on a scale	Standard Deviation 0
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	60 minutes	4.3 score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	90 minutes	4.1 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	120 minutes	4.2 score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	150 minutes	3.7 score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	210 minutes	3.7 score on a scale	Standard Deviation 1.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	240 minutes	4.7 score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	270 minutes	4.5 score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	330 minutes	4.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	450 minutes	1.0 score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]	480 minutes	4.0 score on a scale	Standard Deviation 1.4

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]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: mITT in adolescents

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F]	30 minutes	3.5 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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 of surgery (Day 1)	4.4 score on a scale	Standard Deviation 0.9

Secondary

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

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: mITT in adults with moderate eGFR.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	30 minutes	1.4 score on a scale	Standard Deviation 0.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F]	End of Surgery (Day1)	2.9 score on a scale	Standard Deviation 1.5

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]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: ITT

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Normal/Mild): WL/NIR-F]	30 minutes	2.7 score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	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 of surgery (Day 1)	4.0 score on a scale	Standard Deviation 1.3

p-value: <0.00195% CI: [1, 1.7]paired t test

Secondary

Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]

Time frame: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)

Population: mITT for all cohorts in WL/NIR-F arm

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	30 minutes	2.7 score on a scale	Standard Deviation 1.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]	End of surgery (Day 1)	4.0 score on a scale	Standard Deviation 1.3

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

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. TEAEs included both serious and Other (Not Including Serious) TEAE.

Time frame: From first dose up to 15 days (+ 10 days)

Population: SAF

Arm	Measure	Group	Value (NUMBER)
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	TEAE	8 participants
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Serious TEAE	4 participants
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Serious TEAE	8 participants
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	TEAE	28 participants
Adult (Moderate): White Light/ Near-infrared Fluorescence	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	TEAE	1 participants
Adult (Moderate): White Light/ Near-infrared Fluorescence	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Serious TEAE	0 participants
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	TEAE	7 participants
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Serious TEAE	0 participants

Secondary

Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]

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. Difference in average index ureter conspicuity scores between NIR-F & WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 1, 2, 3 and 4 points higher.

Time frame: WL and NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes

Population: mITT for all cohorts with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	120 minutes	2.4 Score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	240 minutes	4.3 Score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	60 minutes	2.7 Score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	270 minutes	3.8 Score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	150 minutes	2.0 Score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	300 minutes	3.5 Score on a scale	Standard Deviation 2.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	30 minutes	2.8 Score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	330 minutes	2.0 Score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	180 minutes	2.3 Score on a scale	Standard Deviation 1.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	450 minutes	3.0 Score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	210 minutes	2.2 Score on a scale	Standard Deviation 1.8
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	480 minutes	2.0 Score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	90 minutes	2.4 Score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	480 minutes	4.0 Score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	180 minutes	3.7 Score on a scale	Standard Deviation 1.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	30 minutes	4.3 Score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	60 minutes	4.3 Score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	90 minutes	4.2 Score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	120 minutes	4.2 Score on a scale	Standard Deviation 1.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	150 minutes	3.7 Score on a scale	Standard Deviation 1.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	210 minutes	3.7 Score on a scale	Standard Deviation 1.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	240 minutes	4.7 Score on a scale	Standard Deviation 0.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	270 minutes	4.5 Score on a scale	Standard Deviation 1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	300 minutes	5.0 Score on a scale	Standard Deviation 0
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	330 minutes	4.0 Score on a scale	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]	450 minutes	1.0 Score on a scale	—

Secondary

Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)

PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	150-180 minutes	9.52 percentage of drug excreted	Standard Deviation 9.62
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	90-120 minutes	10.8 percentage of drug excreted	Standard Deviation 8.71
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	30-60 minutes	12.5 percentage of drug excreted	Standard Deviation 9.21
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	120-150 minutes	10.0 percentage of drug excreted	Standard Deviation 3.74
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	60-90 minutes	10.1 percentage of drug excreted	Standard Deviation 9.66
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	210-240 minutes	5.82 percentage of drug excreted	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	180-210 minutes	4.90 percentage of drug excreted	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	10-30 minutes	2.58 percentage of drug excreted	Standard Deviation 4.06
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	0-10 minutes	1.48 percentage of drug excreted	Standard Deviation 2.63
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	450-480 minutes	1.00 percentage of drug excreted	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	180-210 minutes	5.03 percentage of drug excreted	Standard Deviation 2.54
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	0-10 minutes	0.633 percentage of drug excreted	Standard Deviation 1.42
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	10-30 minutes	5.46 percentage of drug excreted	Standard Deviation 6.59
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	30-60 minutes	9.15 percentage of drug excreted	Standard Deviation 7.68
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	60-90 minutes	11.3 percentage of drug excreted	Standard Deviation 7.74
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	90-120 minutes	10.2 percentage of drug excreted	Standard Deviation 6.63
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	120-150 minutes	6.77 percentage of drug excreted	Standard Deviation 4.38
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	150-180 minutes	4.78 percentage of drug excreted	Standard Deviation 2.86
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	210-240 minutes	3.12 percentage of drug excreted	Standard Deviation 1.02
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	240-270 minutes	2.68 percentage of drug excreted	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	270- 300 minutes	2.18 percentage of drug excreted	Standard Deviation 0.351
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	300- 330 minutes	1.94 percentage of drug excreted	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	330- 360 minutes	1.46 percentage of drug excreted	Standard Deviation 1.8
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	360-390 minutes	2.69 percentage of drug excreted	Standard Deviation 1.37
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	390-420 minutes	0.877 percentage of drug excreted	Standard Deviation 0.697
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	420-450 minutes	2.78 percentage of drug excreted	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	0-10 minutes	0.238 percentage of drug excreted	Standard Deviation 0.646
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	90-120 minutes	5.03 percentage of drug excreted	Standard Deviation 1.9
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	30-60 minutes	5.83 percentage of drug excreted	Standard Deviation 1.02
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	60-90 minutes	7.20 percentage of drug excreted	Standard Deviation 5.32
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	120-150 minutes	1.70 percentage of drug excreted	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	150-180 minutes	5.70 percentage of drug excreted	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	10-30 minutes	4.06 percentage of drug excreted	Standard Deviation 2.53
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	90-120 minutes	19.3 percentage of drug excreted	Standard Deviation 15.5
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	120-150 minutes	8.54 percentage of drug excreted	Standard Deviation 5.68
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	10-30 minutes	8.18 percentage of drug excreted	Standard Deviation 8.98
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	150-180 minutes	15.0 percentage of drug excreted	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	0-10 minutes	0.0219 percentage of drug excreted	Standard Deviation 0.0657
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	30-60 minutes	7.99 percentage of drug excreted	Standard Deviation 8.59
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	180-210 minutes	5.39 percentage of drug excreted	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	60-90 minutes	11.6 percentage of drug excreted	Standard Deviation 13.9
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)	210-240 minutes	2.34 percentage of drug excreted	—

Secondary

Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration

Concentration of pudexacianinium chloride in plasma. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.

Time frame: Day 1 Postdose: 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390, 360 minutes

Population: 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. Since participants had different end of surgery timepoint, number of observations were different by Arm/Group as the last observation timepoint is different by participant. PKAS with available data was analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	10 minutes	366 nanogram/milliliters (ng/mL)	Standard Deviation 109
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	300 minutes	30.9 nanogram/milliliters (ng/mL)	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	30 minutes	197 nanogram/milliliters (ng/mL)	Standard Deviation 61.2
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	60 minutes	129 nanogram/milliliters (ng/mL)	Standard Deviation 34.4
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	90 minutes	111 nanogram/milliliters (ng/mL)	Standard Deviation 40.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	120 minutes	78.3 nanogram/milliliters (ng/mL)	Standard Deviation 37.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	150 minutes	115 nanogram/milliliters (ng/mL)	Standard Deviation 37.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	180 minutes	59.2 nanogram/milliliters (ng/mL)	Standard Deviation 24.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	210 minutes	47.8 nanogram/milliliters (ng/mL)	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	240 minutes	45.8 nanogram/milliliters (ng/mL)	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	30 minutes	185 nanogram/milliliters (ng/mL)	Standard Deviation 46.8
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	210 minutes	53.8 nanogram/milliliters (ng/mL)	Standard Deviation 16
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	60 minutes	126 nanogram/milliliters (ng/mL)	Standard Deviation 36.1
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	90 minutes	108 nanogram/milliliters (ng/mL)	Standard Deviation 34.6
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	390 minutes	28.9 nanogram/milliliters (ng/mL)	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	120 minutes	79.8 nanogram/milliliters (ng/mL)	Standard Deviation 30.3
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	240 minutes	69.7 nanogram/milliliters (ng/mL)	Standard Deviation 28.5
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	150 minutes	82.8 nanogram/milliliters (ng/mL)	Standard Deviation 29
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	270 minutes	42.4 nanogram/milliliters (ng/mL)	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	180 minutes	61.9 nanogram/milliliters (ng/mL)	Standard Deviation 24.8
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	10 minutes	411 nanogram/milliliters (ng/mL)	Standard Deviation 387
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	300 minutes	51.1 nanogram/milliliters (ng/mL)	Standard Deviation 18.7
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	330 minutes	25.6 nanogram/milliliters (ng/mL)	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	360 minutes	22.4 nanogram/milliliters (ng/mL)	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	210 minutes	97.6 nanogram/milliliters (ng/mL)	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	30 minutes	267 nanogram/milliliters (ng/mL)	Standard Deviation 93.6
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	90 minutes	172 nanogram/milliliters (ng/mL)	Standard Deviation 42.3
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	60 minutes	203 nanogram/milliliters (ng/mL)	Standard Deviation 56.8
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	180 minutes	128 nanogram/milliliters (ng/mL)	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	10 minutes	426 nanogram/milliliters (ng/mL)	Standard Deviation 137
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	120 minutes	147 nanogram/milliliters (ng/mL)	Standard Deviation 44.7
Adult (Moderate): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	150 minutes	128 nanogram/milliliters (ng/mL)	Standard Deviation 25.1
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	120 minutes	99.2 nanogram/milliliters (ng/mL)	Standard Deviation 26.8
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	180 minutes	47.1 nanogram/milliliters (ng/mL)	Standard Deviation 17.5
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	30 minutes	244 nanogram/milliliters (ng/mL)	Standard Deviation 86.4
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	150 minutes	120 nanogram/milliliters (ng/mL)	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	10 minutes	410 nanogram/milliliters (ng/mL)	Standard Deviation 141
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	60 minutes	166 nanogram/milliliters (ng/mL)	Standard Deviation 50.1
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	90 minutes	121 nanogram/milliliters (ng/mL)	Standard Deviation 46.1
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration	270 minutes	34.2 nanogram/milliliters (ng/mL)	—

Secondary

PK of Pudexacianinium Chloride: Urine Concentration

Concentration of pudexacianinium chloride in urine.PK samples were collected up to the end of surgery timepoint of each participant. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if \>=3 participants were evaluated for a specific timepoint.

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	0-10 minutes	1530 ng/mL	Standard Deviation 4100
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	90-120 minutes	17700 ng/mL	Standard Deviation 13300
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	60-90 minutes	16700 ng/mL	Standard Deviation 18100
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	30-60 minutes	18000 ng/mL	Standard Deviation 18600
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	10-30 minutes	4960 ng/mL	Standard Deviation 6050
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	210-240 minutes	5230 ng/mL	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	150-180 minutes	17900 ng/mL	Standard Deviation 7900
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	180-210 minutes	6230 ng/mL	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	PK of Pudexacianinium Chloride: Urine Concentration	120-150 minutes	20700 ng/mL	Standard Deviation 8850
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	0-10 minutes	235 ng/mL	Standard Deviation 629
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	90-120 minutes	14500 ng/mL	Standard Deviation 9630
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	150-180 minutes	9110 ng/mL	Standard Deviation 6530
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	180-210 minutes	8690 ng/mL	Standard Deviation 6920
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	10-30 minutes	10200 ng/mL	Standard Deviation 15600
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	30-60 minutes	19800 ng/mL	Standard Deviation 20300
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	60-90 minutes	20100 ng/mL	Standard Deviation 21200
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	120-150 minutes	10700 ng/mL	Standard Deviation 6880
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	210-240 minutes	5750 ng/mL	Standard Deviation 2310
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	240-270 minutes	5500 ng/mL	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	270- 300 minutes	3690 ng/mL	Standard Deviation 1600
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	300- 330 minutes	4860 ng/mL	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	330- 360 minutes	3630 ng/mL	Standard Deviation 2280
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	360-390 minutes	2650 ng/mL	Standard Deviation 1640
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	390-420 minutes	1570 ng/mL	Standard Deviation 2400
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	420-450 minutes	3150 ng/mL	—
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	PK of Pudexacianinium Chloride: Urine Concentration	450-480 minutes	3070 ng/mL	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	120-150 minutes	17400 ng/mL	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	150-180 minutes	18400 ng/mL	—
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	30-60 minutes	10400 ng/mL	Standard Deviation 6640
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	0-10 minutes	80.4 ng/mL	Standard Deviation 165
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	90-120 minutes	25800 ng/mL	Standard Deviation 37200
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	60-90 minutes	25500 ng/mL	Standard Deviation 17100
Adult (Moderate): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	10-30 minutes	7890 ng/mL	Standard Deviation 3610
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	60-90 minutes	41600 ng/mL	Standard Deviation 41900
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	30-60 minutes	25200 ng/mL	Standard Deviation 22000
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	90-120 minutes	49800 ng/mL	Standard Deviation 62000
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	120-150 minutes	25500 ng/mL	Standard Deviation 16600
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	180-210 minutes	10500 ng/mL	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	150-180 minutes	19600 ng/mL	—
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	10-30 minutes	14200 ng/mL	Standard Deviation 15100
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	0-10 minutes	9.98 ng/mL	Standard Deviation 29.9
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence	PK of Pudexacianinium Chloride: Urine Concentration	210-240 minutes	6500 ng/mL	—

Secondary

Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]

UC was quantified by image analysis when pudexacianinium was present in ureter. Contrast enhancement factor (CEF) was measure of degree to which color contrast (CC) was enhanced in areas in which drug fluorescence signal was present. Images of ureters during surgery were decomposed into red (R), green (G) & blue (B) using Image analysis software. R, G & B video components corresponding to each full color image were exported as 256 shades of gray, ranging from pure black (0) to pure white (255). CC between dye fluorescence in ureter & surrounding tissues was quantified by calculating ratio of signal levels G/(R + B). A higher CEF score=higher (green) contrast in ureter compared to the surrounding tissue. A commensurate ratio value was calculated for signals emanating from tissues surrounding ureter lumen. A comparison of ratio values was expressed as a CEF = (G/(R + B)inside)/(G/(R + B)outside. Overall average data of each time point from first dose up to end of surgery was reported.

Time frame: From first dose every 30 minutes thereafter up to end of surgery (Day 1)

Population: ITT

Arm	Measure	Value (MEAN)	Dispersion
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)	Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]	1.08 ratio	Standard Deviation 0.15
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)	Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]	2.38 ratio	Standard Deviation 1.54

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery

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

Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)

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

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

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

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]

BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]

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

BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]

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

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

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

BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]

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

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

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

Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants]

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]

Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]

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]

Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants]

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

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

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

Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants]

Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)

Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration

PK of Pudexacianinium Chloride: Urine Concentration

Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]