Trial Outcomes & Findings for A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery (NCT NCT05754333)
NCT ID: NCT05754333
Last Updated: 2025-10-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
30 minutes post dose (+/- 15 minutes)
Results posted on
2025-10-09
Participant Flow
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.
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
Participant milestones
| Measure |
Adult (Normal/Mild): White Light/Near-infrared Fluorescence
Pudexacianinium (3 milligrams \[mg\]) was administered as a single intravenous (IV) dose approximately 30 minutes (min) before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. White Light (WL) and near-infrared fluorescence (NIR-F) were used to recognize/identify the ureter.
|
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.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
72
|
13
|
8
|
14
|
|
Overall Study
Participants Did Not Receive Study Drug
|
2
|
0
|
0
|
0
|
|
Overall Study
Modified Intent-to-Treat (mITT)
|
72
|
0
|
8
|
14
|
|
Overall Study
Intent-to-Treat (ITT)
|
72
|
0
|
0
|
0
|
|
Overall Study
Safety Analysis Set (SAF)
|
70
|
13
|
8
|
14
|
|
Overall Study
COMPLETED
|
67
|
12
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Adult (Normal/Mild): White Light/Near-infrared Fluorescence
Pudexacianinium (3 milligrams \[mg\]) was administered as a single intravenous (IV) dose approximately 30 minutes (min) before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. White Light (WL) and near-infrared fluorescence (NIR-F) were used to recognize/identify the ureter.
|
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.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
Overall Study
Miscellaneous
|
3
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
Baseline characteristics by cohort
| Measure |
Adult (Normal/Mild): White Light/Near-infrared Fluorescence
n=70 Participants
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.
|
Adult (Normal/Mild): White Light Only
n=13 Participants
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.
|
Adult (Moderate): White Light/Near-infrared Fluorescence
n=8 Participants
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.
|
Adolescent (Normal/Mild): WL/NIR-F
n=14 Participants
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.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.5 Years
STANDARD_DEVIATION 15.0 • n=99 Participants
|
52.2 Years
STANDARD_DEVIATION 21.6 • n=107 Participants
|
70.3 Years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
14.4 Years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
49.9 Years
STANDARD_DEVIATION 20.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
72 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
85 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Type of Surgery (Gynecological & Other-Abdominopelvic)
Gynecological
|
15 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
|
Type of Surgery (Gynecological & Other-Abdominopelvic)
Other- Abdominopelvic
|
55 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
81 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: ITT
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.3 score on a scale
Standard Deviation 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutesPopulation: ITT with available data was analyzed
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.3 score on a scale
Standard Deviation 1.2
|
—
|
—
|
|
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]
60 minutes
|
—
|
4.3 score on a scale
Standard Deviation 1.2
|
—
|
—
|
|
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]
90 minutes
|
—
|
4.2 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: ITT
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose every 30 minutes thereafter up to end of surgery (Day 1)Population: ITT
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F]
|
1.08 ratio
Standard Deviation 0.15
|
2.38 ratio
Standard Deviation 1.54
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: Modified Intent to Treat (mITT): All adolescent participants in the WL/NIR-F arm
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.4 score on a scale
Standard Deviation 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutesPopulation: mITT in adolescents with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the 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]
30 minutes
|
3.5 score on a scale
Standard Deviation 1.5
|
4.4 score on a scale
Standard Deviation 1.2
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: mITT in adolescents
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the 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]
30 minutes
|
3.5 score on a scale
Standard Deviation 1.5
|
—
|
—
|
—
|
|
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 outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: mITT in adults with moderate eGFR in the WL/NIR-F arm.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
2.9 score on a scale
Standard Deviation 1.1
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutesPopulation: mITT in adults with moderate eGFR with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the 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]
90 minutes
|
—
|
3.2 score on a scale
Standard Deviation 1.6
|
—
|
—
|
|
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
|
2.9 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: mITT in adults with moderate eGFR.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
|
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 outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: mITT that included all participants in any cohort in the WL/NIR-F arm.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.2 score on a scale
Standard Deviation 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutesPopulation: mITT for all cohorts in WL/NIR-F arm with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.2 score on a scale
Standard Deviation 1.2
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only 1 participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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 outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: mITT for all cohorts in WL/NIR-F arm
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
|
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 outcome
Timeframe: WL and NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutesPopulation: mITT for all cohorts with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the 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]
30 minutes
|
2.8 Score on a scale
Standard Deviation 1.5
|
4.3 Score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
4.3 Score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
4.2 Score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
4.2 Score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
3.7 Score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
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
|
3.7 Score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
3.7 Score on a scale
Standard Deviation 1.7
|
—
|
—
|
|
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
|
4.7 Score on a scale
Standard Deviation 0.6
|
—
|
—
|
|
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
|
4.5 Score on a scale
Standard Deviation 1.0
|
—
|
—
|
|
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
|
5.0 Score on a scale
Standard Deviation 0.0
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
4.0 Score on a scale
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
1.0 Score on a scale
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
4.0 Score on a scale
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: ITT
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
3.4 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
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
|
3.2 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
4.3 score on a scale
Standard Deviation 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutesPopulation: ITT with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
3.4 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
3.2 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
4.3 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
Reader 4, 60 minute
|
—
|
4.4 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence SD was not evaluable
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: ITT
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=72 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: mITT in adolescents
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.8 score on a scale
Standard Deviation 0.6
|
—
|
—
|
|
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
|
3.9 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
4.1 score on a scale
Standard Deviation 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutesPopulation: mITT in adolescents with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
4.1 score on a scale
Standard Deviation 1.0
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
3.9 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
4.8 score on a scale
Standard Deviation 0.6
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: mITT in adolescents
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=14 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: mITT in adults with moderate eGFR
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
2.4 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
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
|
2.4 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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
|
4.1 score on a scale
Standard Deviation 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutesPopulation: mITT in adults with moderate eGFR with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
2.4 score on a scale
Standard Deviation 1.1
|
—
|
—
|
|
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 0.0
|
—
|
—
|
|
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
|
2.4 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]
Reader 2: 60 minutes
|
—
|
3.5 score on a scale
Standard Deviation 2.1
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
4.1 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F]
Reader 4: 60 minutes
|
—
|
4.5 score on a scale
Standard Deviation 0.7
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: mITT in adults with moderate eGFR
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=8 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes post dose (+/- 15 minutes)Population: mITT for all cohorts in WL/NIR-F arm
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
4.4 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
3.4 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
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
|
3.3 score on a scale
Standard Deviation 1.3
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutesPopulation: mITT for all cohorts in WL/NIR-F arm with available data was analyzed.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
3.4 score on a scale
Standard Deviation 1.4
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
3.3 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
4.4 score on a scale
Standard Deviation 1.3
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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
|
—
|
—
|
|
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 1.0
|
—
|
—
|
|
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
|
—
|
—
|
|
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
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1)Population: mITT for all cohorts in WL/NIR-F arm
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=94 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
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.
|
Adolescent (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 adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter.
|
|---|---|---|---|---|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
|
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
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose up to 15 days (+ 10 days)Population: SAF
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=13 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=70 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
Adult (Moderate): White Light/ Near-infrared Fluorescence
n=8 Participants
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.
|
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence
n=14 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAE
|
8 participants
|
28 participants
|
1 participants
|
7 participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Serious TEAE
|
4 participants
|
8 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1 Postdose: 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390, 360 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=13 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=62 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
Adult (Moderate): White Light/ Near-infrared Fluorescence
n=8 Participants
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.
|
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence
n=14 Participants
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.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
240 minutes
|
45.8 nanogram/milliliters (ng/mL)
Standard Deviation NA
Only 1 participant was analyzed, hence SD was not evaluable.
|
69.7 nanogram/milliliters (ng/mL)
Standard Deviation 28.5
|
—
|
—
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
10 minutes
|
366 nanogram/milliliters (ng/mL)
Standard Deviation 109
|
411 nanogram/milliliters (ng/mL)
Standard Deviation 387
|
426 nanogram/milliliters (ng/mL)
Standard Deviation 137
|
410 nanogram/milliliters (ng/mL)
Standard Deviation 141
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
30 minutes
|
197 nanogram/milliliters (ng/mL)
Standard Deviation 61.2
|
185 nanogram/milliliters (ng/mL)
Standard Deviation 46.8
|
267 nanogram/milliliters (ng/mL)
Standard Deviation 93.6
|
244 nanogram/milliliters (ng/mL)
Standard Deviation 86.4
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
60 minutes
|
129 nanogram/milliliters (ng/mL)
Standard Deviation 34.4
|
126 nanogram/milliliters (ng/mL)
Standard Deviation 36.1
|
203 nanogram/milliliters (ng/mL)
Standard Deviation 56.8
|
166 nanogram/milliliters (ng/mL)
Standard Deviation 50.1
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
90 minutes
|
111 nanogram/milliliters (ng/mL)
Standard Deviation 40.5
|
108 nanogram/milliliters (ng/mL)
Standard Deviation 34.6
|
172 nanogram/milliliters (ng/mL)
Standard Deviation 42.3
|
121 nanogram/milliliters (ng/mL)
Standard Deviation 46.1
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
120 minutes
|
78.3 nanogram/milliliters (ng/mL)
Standard Deviation 37.1
|
79.8 nanogram/milliliters (ng/mL)
Standard Deviation 30.3
|
147 nanogram/milliliters (ng/mL)
Standard Deviation 44.7
|
99.2 nanogram/milliliters (ng/mL)
Standard Deviation 26.8
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
150 minutes
|
115 nanogram/milliliters (ng/mL)
Standard Deviation 37.3
|
82.8 nanogram/milliliters (ng/mL)
Standard Deviation 29.0
|
128 nanogram/milliliters (ng/mL)
Standard Deviation 25.1
|
120 nanogram/milliliters (ng/mL)
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
180 minutes
|
59.2 nanogram/milliliters (ng/mL)
Standard Deviation 24.1
|
61.9 nanogram/milliliters (ng/mL)
Standard Deviation 24.8
|
128 nanogram/milliliters (ng/mL)
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
47.1 nanogram/milliliters (ng/mL)
Standard Deviation 17.5
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
210 minutes
|
47.8 nanogram/milliliters (ng/mL)
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
53.8 nanogram/milliliters (ng/mL)
Standard Deviation 16.0
|
97.6 nanogram/milliliters (ng/mL)
Standard Deviation NA
Only one participant was analyzed, hence SD is not evaluable
|
—
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
270 minutes
|
—
|
42.4 nanogram/milliliters (ng/mL)
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
34.2 nanogram/milliliters (ng/mL)
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
300 minutes
|
30.9 nanogram/milliliters (ng/mL)
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
51.1 nanogram/milliliters (ng/mL)
Standard Deviation 18.7
|
—
|
—
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
330 minutes
|
—
|
25.6 nanogram/milliliters (ng/mL)
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
360 minutes
|
—
|
22.4 nanogram/milliliters (ng/mL)
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration
390 minutes
|
—
|
28.9 nanogram/milliliters (ng/mL)
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=11 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=56 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
Adult (Moderate): White Light/ Near-infrared Fluorescence
n=8 Participants
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.
|
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence
n=13 Participants
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.
|
|---|---|---|---|---|
|
PK of Pudexacianinium Chloride: Urine Concentration
360-390 minutes
|
—
|
2650 ng/mL
Standard Deviation 1640
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
10-30 minutes
|
4960 ng/mL
Standard Deviation 6050
|
10200 ng/mL
Standard Deviation 15600
|
7890 ng/mL
Standard Deviation 3610
|
14200 ng/mL
Standard Deviation 15100
|
|
PK of Pudexacianinium Chloride: Urine Concentration
30-60 minutes
|
18000 ng/mL
Standard Deviation 18600
|
19800 ng/mL
Standard Deviation 20300
|
10400 ng/mL
Standard Deviation 6640
|
25200 ng/mL
Standard Deviation 22000
|
|
PK of Pudexacianinium Chloride: Urine Concentration
90-120 minutes
|
17700 ng/mL
Standard Deviation 13300
|
14500 ng/mL
Standard Deviation 9630
|
25800 ng/mL
Standard Deviation 37200
|
49800 ng/mL
Standard Deviation 62000
|
|
PK of Pudexacianinium Chloride: Urine Concentration
210-240 minutes
|
5230 ng/mL
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
5750 ng/mL
Standard Deviation 2310
|
—
|
6500 ng/mL
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
|
PK of Pudexacianinium Chloride: Urine Concentration
390-420 minutes
|
—
|
1570 ng/mL
Standard Deviation 2400
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
420-450 minutes
|
—
|
3150 ng/mL
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
450-480 minutes
|
—
|
3070 ng/mL
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
0-10 minutes
|
1530 ng/mL
Standard Deviation 4100
|
235 ng/mL
Standard Deviation 629
|
80.4 ng/mL
Standard Deviation 165
|
9.98 ng/mL
Standard Deviation 29.9
|
|
PK of Pudexacianinium Chloride: Urine Concentration
60-90 minutes
|
16700 ng/mL
Standard Deviation 18100
|
20100 ng/mL
Standard Deviation 21200
|
25500 ng/mL
Standard Deviation 17100
|
41600 ng/mL
Standard Deviation 41900
|
|
PK of Pudexacianinium Chloride: Urine Concentration
120-150 minutes
|
20700 ng/mL
Standard Deviation 8850
|
10700 ng/mL
Standard Deviation 6880
|
17400 ng/mL
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
25500 ng/mL
Standard Deviation 16600
|
|
PK of Pudexacianinium Chloride: Urine Concentration
150-180 minutes
|
17900 ng/mL
Standard Deviation 7900
|
9110 ng/mL
Standard Deviation 6530
|
18400 ng/mL
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
19600 ng/mL
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
|
PK of Pudexacianinium Chloride: Urine Concentration
180-210 minutes
|
6230 ng/mL
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
8690 ng/mL
Standard Deviation 6920
|
—
|
10500 ng/mL
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
|
PK of Pudexacianinium Chloride: Urine Concentration
240-270 minutes
|
—
|
5500 ng/mL
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
270- 300 minutes
|
—
|
3690 ng/mL
Standard Deviation 1600
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
300- 330 minutes
|
—
|
4860 ng/mL
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
PK of Pudexacianinium Chloride: Urine Concentration
330- 360 minutes
|
—
|
3630 ng/mL
Standard Deviation 2280
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=10 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=56 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
Adult (Moderate): White Light/ Near-infrared Fluorescence
n=8 Participants
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.
|
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence
n=13 Participants
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.
|
|---|---|---|---|---|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
0-10 minutes
|
0.0443 milligrams
Standard Deviation 0.0790
|
0.0190 milligrams
Standard Deviation 0.0425
|
0.00713 milligrams
Standard Deviation 0.0194
|
0.000657 milligrams
Standard Deviation 0.00197
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
120-150 minutes
|
0.301 milligrams
Standard Deviation 0.112
|
0.203 milligrams
Standard Deviation 0.131
|
0.0511 milligrams
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
0.256 milligrams
Standard Deviation 0.170
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
210-240 minutes
|
0.175 milligrams
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
0.0937 milligrams
Standard Deviation 0.0307
|
—
|
0.0702 milligrams
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
450- 480 minutes
|
—
|
0.0301 milligrams
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
10-30 minutes
|
0.0773 milligrams
Standard Deviation 0.122
|
0.164 milligrams
Standard Deviation 0.198
|
0.122 milligrams
Standard Deviation 0.0759
|
0.245 milligrams
Standard Deviation 0.269
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
30-60 minutes
|
0.375 milligrams
Standard Deviation 0.276
|
0.274 milligrams
Standard Deviation 0.230
|
0.175 milligrams
Standard Deviation 0.0305
|
0.240 milligrams
Standard Deviation 0.258
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
60-90 minutes
|
0.304 milligrams
Standard Deviation 0.290
|
0.340 milligrams
Standard Deviation 0.232
|
0.216 milligrams
Standard Deviation 0.160
|
0.348 milligrams
Standard Deviation 0.417
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
90-120 minutes
|
0.325 milligrams
Standard Deviation 0.261
|
0.306 milligrams
Standard Deviation 0.199
|
0.151 milligrams
Standard Deviation 0.0570
|
0.578 milligrams
Standard Deviation 0.465
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
150-180 minutes
|
0.286 milligrams
Standard Deviation 0.289
|
0.143 milligrams
Standard Deviation 0.0859
|
0.171 milligrams
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
0.450 milligrams
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
180-210 minutes
|
0.147 milligrams
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
0.151 milligrams
Standard Deviation 0.0763
|
—
|
0.162 milligrams
Standard Deviation NA
Only one participant was analyzed hence, SD is not evaluable
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
240-270 minutes
|
—
|
0.0803 milligrams
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
270- 300 minutes
|
—
|
0.0655 milligrams
Standard Deviation 0.0105
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
300- 330 minutes
|
—
|
0.0582 milligrams
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
330- 360 minutes
|
—
|
0.0438 milligrams
Standard Deviation 0.0541
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
360-390 minutes
|
—
|
0.0808 milligrams
Standard Deviation 0.0412
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
390-420 minutes
|
—
|
0.0263 milligrams
Standard Deviation 0.0209
|
—
|
—
|
|
Amount of Pudexacianinium Chloride Excreted Into Urine (Ae)
420-450 minutes
|
—
|
0.0835 milligrams
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL)
n=10 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. WL was reported for this arm.
|
Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F)
n=56 Participants
Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. NIR-F was reported for this arm.
|
Adult (Moderate): White Light/ Near-infrared Fluorescence
n=8 Participants
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.
|
Adolescent (Normal/Mild): White Light/ Near-infrared Fluorescence
n=13 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
10-30 minutes
|
2.58 percentage of drug excreted
Standard Deviation 4.06
|
5.46 percentage of drug excreted
Standard Deviation 6.59
|
4.06 percentage of drug excreted
Standard Deviation 2.53
|
8.18 percentage of drug excreted
Standard Deviation 8.98
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
30-60 minutes
|
12.5 percentage of drug excreted
Standard Deviation 9.21
|
9.15 percentage of drug excreted
Standard Deviation 7.68
|
5.83 percentage of drug excreted
Standard Deviation 1.02
|
7.99 percentage of drug excreted
Standard Deviation 8.59
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
60-90 minutes
|
10.1 percentage of drug excreted
Standard Deviation 9.66
|
11.3 percentage of drug excreted
Standard Deviation 7.74
|
7.20 percentage of drug excreted
Standard Deviation 5.32
|
11.6 percentage of drug excreted
Standard Deviation 13.9
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
390-420 minutes
|
—
|
0.877 percentage of drug excreted
Standard Deviation 0.697
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
0-10 minutes
|
1.48 percentage of drug excreted
Standard Deviation 2.63
|
0.633 percentage of drug excreted
Standard Deviation 1.42
|
0.238 percentage of drug excreted
Standard Deviation 0.646
|
0.0219 percentage of drug excreted
Standard Deviation 0.0657
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
90-120 minutes
|
10.8 percentage of drug excreted
Standard Deviation 8.71
|
10.2 percentage of drug excreted
Standard Deviation 6.63
|
5.03 percentage of drug excreted
Standard Deviation 1.90
|
19.3 percentage of drug excreted
Standard Deviation 15.5
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
120-150 minutes
|
10.0 percentage of drug excreted
Standard Deviation 3.74
|
6.77 percentage of drug excreted
Standard Deviation 4.38
|
1.70 percentage of drug excreted
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
8.54 percentage of drug excreted
Standard Deviation 5.68
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
150-180 minutes
|
9.52 percentage of drug excreted
Standard Deviation 9.62
|
4.78 percentage of drug excreted
Standard Deviation 2.86
|
5.70 percentage of drug excreted
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
15.0 percentage of drug excreted
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
180-210 minutes
|
4.90 percentage of drug excreted
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
5.03 percentage of drug excreted
Standard Deviation 2.54
|
—
|
5.39 percentage of drug excreted
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
210-240 minutes
|
5.82 percentage of drug excreted
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
3.12 percentage of drug excreted
Standard Deviation 1.02
|
—
|
2.34 percentage of drug excreted
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
240-270 minutes
|
—
|
2.68 percentage of drug excreted
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
270- 300 minutes
|
—
|
2.18 percentage of drug excreted
Standard Deviation 0.351
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
300- 330 minutes
|
—
|
1.94 percentage of drug excreted
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
330- 360 minutes
|
—
|
1.46 percentage of drug excreted
Standard Deviation 1.80
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
360-390 minutes
|
—
|
2.69 percentage of drug excreted
Standard Deviation 1.37
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
420-450 minutes
|
—
|
2.78 percentage of drug excreted
Standard Deviation NA
Based on an internal programming guideline SD was reported if at least 3 participants were analyzed
|
—
|
—
|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%)
450-480 minutes
|
—
|
1.00 percentage of drug excreted
Standard Deviation NA
Only one participant was analyzed, hence SD was not evaluable
|
—
|
—
|
Adverse Events
Adult (Normal/Mild): White Light/Near-infrared Fluorescence
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Adult (Normal/Mild): White Light Only
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Adult (Moderate): White Light/Near-infrared Fluorescence
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adolescent (Normal/Mild): WL/NIR-F
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adult (Normal/Mild): White Light/Near-infrared Fluorescence
n=70 participants at risk
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.
|
Adult (Normal/Mild): White Light Only
n=13 participants at risk
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.
|
Adult (Moderate): White Light/Near-infrared Fluorescence
n=8 participants at risk
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.
|
Adolescent (Normal/Mild): WL/NIR-F
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Cardiac disorders
Palpitations
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
15.4%
2/13 • Number of events 2 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Nervous system disorders
Loss of consciousness
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Psychiatric disorders
Delirium
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/70 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
Other adverse events
| Measure |
Adult (Normal/Mild): White Light/Near-infrared Fluorescence
n=70 participants at risk
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.
|
Adult (Normal/Mild): White Light Only
n=13 participants at risk
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.
|
Adult (Moderate): White Light/Near-infrared Fluorescence
n=8 participants at risk
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.
|
Adolescent (Normal/Mild): WL/NIR-F
n=14 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
4/70 • Number of events 4 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Blood and lymphatic system disorders
Dilutional anaemia
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Cardiac disorders
Sinus bradycardia
|
2.9%
2/70 • Number of events 2 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
3/70 • Number of events 3 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
12.5%
1/8 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Investigations
Blood creatine phosphokinase increased
|
2.9%
2/70 • Number of events 2 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.1%
1/14 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Renal and urinary disorders
Chromaturia
|
2.9%
2/70 • Number of events 2 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/13 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
35.7%
5/14 • Number of events 5 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
|
Renal and urinary disorders
Loss of bladder sensation
|
0.00%
0/70 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
7.7%
1/13 • Number of events 1 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/8 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
0.00%
0/14 • All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
|
Additional Information
Clinical Transparency
Astellas Pharma Global Development, Inc
Phone: 8008887704
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER