Trial Outcomes & Findings for A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery (NCT NCT04238481)
NCT ID: NCT04238481
Last Updated: 2024-10-24
Results Overview
The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes was considered. If both time points (before and after 30 minutes) were successful, 30 minutes anatomical visualization was imputed as successful. If both time points were not successful, then 30 minutes anatomical visualization was imputed as not successful, and all other cases were not imputed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
30 minutes postdose through end of surgery (on day 1)
Results posted on
2024-10-24
Participant Flow
Participants undergoing laparoscopic/minimally invasive colorectal surgery in which the need for anatomical visualization of the ureter was anticipated were enrolled into this study.
Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. A total of 13 participants were randomized, of which 12 participants received study drug.
Participant milestones
| Measure |
Pudexacianinium Chloride - Dose Level A
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level C
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
3
|
3
|
|
Overall Study
Treated
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pudexacianinium Chloride - Dose Level A
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level C
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Overall Study
Miscellaneous
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
Baseline characteristics by cohort
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
56.7 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 5.7 • n=4 Participants
|
51.9 years
STANDARD_DEVIATION 11.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 minutes postdose through end of surgery (on day 1)Population: FAS Population
The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes was considered. If both time points (before and after 30 minutes) were successful, 30 minutes anatomical visualization was imputed as successful. If both time points were not successful, then 30 minutes anatomical visualization was imputed as not successful, and all other cases were not imputed.
Outcome measures
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s)
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
SECONDARY outcome
Timeframe: From first dose of study drug until follow-up period (day 10)Population: The safety analysis set (SAF) consisted of all randomized participants who received pudexacianinium chloride.
An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product (IP), and which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP. A TEAE was defined as an AE observed after administration of the IP and up to the follow-up period. An AE was considered "serious" if the event: results in death;is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions;results in congenital anomaly, or birth defect;requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization; Other medically important events.
Outcome measures
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Predose, 10, 30, 60, 90, 120 minutes, end of surgery, 180 mins post dosePopulation: The pharmacokinetic analysis set (PKAS) consisted of all randomized participants who received pudexacianinium chloride and had at least 1 plasma or urine concentration data available with the time of dosing and sampling. Participants with available data at specified time point were included in the analysis.
Plasma concentration of pudexacianinium chloride was reported from the blood samples collected. Concentrations below the lower limit of quantification (1 nanogram per milliliter \[ng/mL\]) are set to zero.
Outcome measures
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Plasma Concentration of Pudexacianinium Chloride
Predose
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Plasma Concentration of Pudexacianinium Chloride
10 Minutes
|
48.9 ng/mL
Standard Deviation 20.6
|
196 ng/mL
Standard Deviation 161
|
322 ng/mL
Standard Deviation 177
|
272 ng/mL
Standard Deviation 278
|
|
Plasma Concentration of Pudexacianinium Chloride
30 Minutes
|
22.5 ng/mL
Standard Deviation 3.30
|
58.0 ng/mL
Standard Deviation 5.74
|
146 ng/mL
Standard Deviation 46.1
|
81.1 ng/mL
Standard Deviation 16.2
|
|
Plasma Concentration of Pudexacianinium Chloride
60 Minutes
|
15.3 ng/mL
|
38.2 ng/mL
Standard Deviation 7.35
|
106 ng/mL
|
—
|
|
Plasma Concentration of Pudexacianinium Chloride
90 Minutes
|
12.7 ng/mL
|
34.4 ng/mL
|
—
|
—
|
|
Plasma Concentration of Pudexacianinium Chloride
120 Minutes
|
8.37 ng/mL
|
—
|
—
|
—
|
|
Plasma Concentration of Pudexacianinium Chloride
End of Surgery
|
14.0 ng/mL
Standard Deviation 5.98
|
28.0 ng/mL
Standard Deviation 1.64
|
47.3 ng/mL
Standard Deviation 29.8
|
51.0 ng/mL
Standard Deviation 14.7
|
|
Plasma Concentration of Pudexacianinium Chloride
180 Minutes
|
—
|
18.0 ng/mL
|
—
|
41.5 ng/mL
|
SECONDARY outcome
Timeframe: Predose, 10, 30, 60, 90 minutes, end of surgery, 180 mins post dosePopulation: PKAS population with available data at specified time point.
Urine concentration of pudexacianinium chloride was reported from the urine samples collected. Concentrations below the lower limit of quantification (20 ng/mL) are set to zero.
Outcome measures
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=2 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Urine Concentration of Pudexacianinium Chloride
Predose
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
|
Urine Concentration of Pudexacianinium Chloride
10 Minutes
|
0 ng/mL
|
695 ng/mL
Standard Deviation 983
|
—
|
—
|
|
Urine Concentration of Pudexacianinium Chloride
30 Minutes
|
—
|
10800 ng/mL
Standard Deviation 8620
|
—
|
—
|
|
Urine Concentration of Pudexacianinium Chloride
60 Minutes
|
—
|
12000 ng/mL
Standard Deviation 7420
|
—
|
—
|
|
Urine Concentration of Pudexacianinium Chloride
90 Minutes
|
—
|
6800 ng/mL
|
—
|
—
|
|
Urine Concentration of Pudexacianinium Chloride
End of Surgery
|
1960 ng/mL
Standard Deviation 955
|
4840 ng/mL
Standard Deviation 3650
|
33800 ng/mL
Standard Deviation 636
|
—
|
|
Urine Concentration of Pudexacianinium Chloride
180 Minutes
|
—
|
953 ng/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: During surgery (on day 1)Population: PKAS population with available data at specified time point.
Amount of pudexacianinium chloride excreted in urine during surgery was reported.
Outcome measures
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=2 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=1 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Amount of Pudexacianinium Chloride Excreted in Urine (Ae) During Surgery
|
0.0670 milligrams (mg)
Standard Deviation 0.0239
|
0.212 milligrams (mg)
Standard Deviation 0.0339
|
1.19 milligrams (mg)
Standard Deviation 0.371
|
0.0438 milligrams (mg)
|
SECONDARY outcome
Timeframe: During surgery (on day 1)Population: PKAS population with available data at specified time point.
Percentage of pudexacianinium chloride dose excreted into urine during surgery was reported.
Outcome measures
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=2 Participants
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of Interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 Participants
Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=1 Participants
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) During Surgery
|
22.3 percentage of drug excreted
Standard Deviation 7.98
|
21.2 percentage of drug excreted
Standard Deviation 3.39
|
39.5 percentage of drug excreted
Standard Deviation 12.4
|
4.38 percentage of drug excreted
|
Adverse Events
Pudexacianinium Chloride - Dose Level A
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Pudexacianinium Chloride - Dose Level B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pudexacianinium Chloride - Dose Level C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pudexacianinium Chloride - Dose Level B - Dose Expansion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 participants at risk
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 participants at risk
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 participants at risk
Participants received single dose pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 participants at risk
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Gastrointestinal disorders
Rectal perforation
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
Other adverse events
| Measure |
Pudexacianinium Chloride - Dose Level A
n=3 participants at risk
Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B
n=3 participants at risk
Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level C
n=3 participants at risk
Participants received single dose pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
Pudexacianinium Chloride - Dose Level B - Dose Expansion
n=3 participants at risk
Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
0.00%
0/3 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
33.3%
1/3 • Number of events 1 • From first dose of study drug until follow-up period (day 10)
SAF Population
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Inc
Phone: +81 3-3244-6500 Japanese only
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