| Primary | Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Normal/Mild): WL/NIR-F] | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002.7± 1.5
- OG0014.3± 1.2
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | paired t Test | | <0.001 | | Mean Difference (Final Values) | 1.5 | Standard Error of the Mean | 0.2 | 2-Sided | 95 | 1.2 | 1.9 | | | Mean Difference was calculated by averaging over the differences between WL scores and NIR-F scores at 30-min timepoint. | | Superiority | | |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Normal/Mild): WL/NIR-F] | 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. | ITT with available data was analyzed | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes (+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes | | | | ID | Title | Description |
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| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | 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. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Normal/Mild): WL/NIR-F] | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | 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. |
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| Secondary | Quantification of Ureter Conspicuity for WL and NIR-F Illumination Modes [Adult (Normal/Mild): WL/NIR-F] | UC was quantified by image analysis when pudexacianinium was present in ureter. Contrast enhancement factor (CEF) was measure of degree to which color contrast (CC) was enhanced in areas in which drug fluorescence signal was present. Images of ureters during surgery were decomposed into red (R), green (G) & blue (B) using Image analysis software. R, G & B video components corresponding to each full color image were exported as 256 shades of gray, ranging from pure black (0) to pure white (255). CC between dye fluorescence in ureter & surrounding tissues was quantified by calculating ratio of signal levels G/(R + B). A higher CEF score=higher (green) contrast in ureter compared to the surrounding tissue. A commensurate ratio value was calculated for signals emanating from tissues surrounding ureter lumen. A comparison of ratio values was expressed as a CEF = (G/(R + B)inside)/(G/(R + B)outside. Overall average data of each time point from first dose up to end of surgery was reported. | | Posted | | Mean | Standard Deviation | ratio | | From first dose every 30 minutes thereafter up to end of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F] | 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. | Modified Intent to Treat (mITT): All adolescent participants in the WL/NIR-F arm | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adolescent (Normal/Mild): WL/NIR-F] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT in adolescents with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes | | | | ID | Title | Description |
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| OG000 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F] | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT in adults with moderate eGFR in the WL/NIR-F arm. | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
| |
| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT in adults with moderate eGFR with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes | | | | ID | Title | Description |
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| OG000 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT in adults with moderate eGFR. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
|---|
| OG000 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT that included all participants in any cohort in the WL/NIR-F arm. | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT for all cohorts in WL/NIR-F arm with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Investigator Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. | mITT for all cohorts in WL/NIR-F arm | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | Percentage of Participants (POP) With an Average Index Ureter Conspicuity Under NIR-F at Least 1, 2, 3 or 4 Point Higher Than the Average Index Ureter Conspicuity Under WL Over All Time Points [All Participants] | Ureter conspicuity was scored individually for each illumination mode using a 5-Point Likert Scale, ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Difference in average index ureter conspicuity scores between NIR-F & WL across all timepoints was calculated for each participant. These were categorized based on if NIR-F score was at least 1, 2, 3 and 4 points higher. | mITT for all cohorts with available data was analyzed. | Posted | | Mean | Standard Deviation | Score on a scale | | WL and NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 450, 480 minutes | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | |
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| Secondary | Blinded Independent Central Reviewer (BICR) Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes (Adult (Normal/Mild): WL/NIR-F) and Concordance Correlation Coefficient (CCC) Between Investigator and BICR Reader | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Concordance correlation coefficient (CCC) measures the agreement between investigator and BICR reader for the value difference between WL + NIR-F at 30 min timepoint. Results were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 minutes is reported in Outcome measure #1. | | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Normal/Mild): WL/NIR-F] and CCC Between Investigator and BICR Reader | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. CCC is concordance correlation coefficient, & it measures agreement between investigator and BICR reader for value difference between WL at 30-mintimepoint & average of all NIR-F time points. Result were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F an average of all timepoints is reported in Outcome measure #2. | ITT with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes | | | | ID | Title | Description |
|---|
| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Normal/Mild): WL/NIR-F] and CCC Between Investigator and BICR Reader | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. CCC is concordance correlation coefficient, and it measures the agreement between investigator and BICR reader for the value difference between WL at 30-min timepoint and the end of surgery score under NIR-F. Results were reported for Reader 2, Reader 3 and Reader 4. Descriptive data for Investigator Conspicuity Score Difference in Ureter Between WL at 30 minutes and NIR-F at end of Surgery is reported in Outcome measure #3. | | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | 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. | | OG001 | Adult (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adolescent (Normal/Mild): WL/NIR-F | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adolescent (Normal/Mild): WL/NIR-F] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT in adolescents with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210 minutes | | | | ID | Title | Description |
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| OG000 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adolescent (Normal/Mild): WL/NIR-F] | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adolescent (Normal/Mild): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Moderate): WL/NIR-F] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT in adults with moderate eGFR | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [Adult (Moderate): WL/NIR-F] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT in adults with moderate eGFR with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180 minutes | | | | ID | Title | Description |
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| OG000 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [Adult (Moderate): WL/NIR-F] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT in adults with moderate eGFR | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | Adult (Moderate): White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [All Participants] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT for all cohorts in WL/NIR-F arm | Posted | | Mean | Standard Deviation | score on a scale | | 30 minutes post dose (+/- 15 minutes) | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F an Average of All Timepoints [All Participants] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT for all cohorts in WL/NIR-F arm with available data was analyzed. | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minutes(+/- 15 minutes); NIR-F: 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 480 minutes | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIR-F was reported for this arm. |
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| Secondary | BICR Conspicuity Score Difference in Ureter Between WL at 30 Minutes and NIR-F at End of Surgery [All Participants] | BICR's conspicuity assessment of the ureter was scored individually for each illumination mode using a 5-Point Likert Scale ranging from 1 to 5 where 1= none (not self-evident), 2= poor (somewhat self-evident), 3= sufficient (sufficiently self-evident), 4= good (clearly self-evident), 5= excellent (extremely self-evident). All participants had conspicuity scores from one ureter. Results were reported for Reader 2, Reader 3 and Reader 4. | mITT for all cohorts in WL/NIR-F arm | Posted | | Mean | Standard Deviation | score on a scale | | WL: 30 minute post dose (+/- 15 minutes); NIR-F: End of surgery (Day 1) | | | | ID | Title | Description |
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| OG000 | All Participants: White Light +Near-infrared Fluorescence (Only WL) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only WL was reported for this arm. | | OG001 | All Participants: White Light +Near-infrared Fluorescence (Only NIR-F) | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult and adolescent participants with normal renal function or mild or moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. Only NIRF was reported for this arm. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily had a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether considered related to the IP. A TEAE was defined as an AE with onset at any time from first dosing until the follow up period. AEs were considered serious (SAEs) if the AE resulted, in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. TEAEs included both serious and Other (Not Including Serious) TEAE. | | Posted | | Number | | participants | | From first dose up to 15 days (+ 10 days) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Adult (Normal/Mild): White Light/Near-infrared Fluorescence |
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| Secondary | Pharmacokinetics (PK) of Pudexacianinium Chloride: Plasma Concentration | Concentration of pudexacianinium chloride in plasma. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. | 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. | Posted | | Mean | Standard Deviation | nanogram/milliliters (ng/mL) | | Day 1 Postdose: 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 390, 360 minutes | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Adult (Normal/Mild): White Light/ Near-infrared Fluorescence | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 minutes 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. |
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| Secondary | PK of Pudexacianinium Chloride: Urine Concentration | Concentration of pudexacianinium chloride in urine.PK samples were collected up to the end of surgery timepoint of each participant. PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Adult (Normal/Mild): White Light/ Near-infrared Fluorescence | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 minutes 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. |
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| Secondary | Amount of Pudexacianinium Chloride Excreted Into Urine (Ae) | PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. | 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. | Posted | | Mean | Standard Deviation | milligrams | | Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Adult (Normal/Mild): White Light/ Near-infrared Fluorescence | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 minutes 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. | | OG002 | Adult (Moderate): White Light/ Near-infrared Fluorescence |
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| Secondary | Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) | PK samples were collected up to the end of surgery timepoint of each participant. As planned SD was reported only if >=3 participants were evaluated for a specific timepoint. | 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. | Posted | | Mean | Standard Deviation | percentage of drug excreted | | Day 1 Postdose: 0-10, 10-30, 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360, 360-390, 390-420, 420-450, 450-480 minutes | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Adult (Normal/Mild): White Light/ Near-infrared Fluorescence | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 minutes 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. | | OG002 |
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