Trial Outcomes & Findings for Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation (NCT NCT01438957)
NCT ID: NCT01438957
Last Updated: 2021-03-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
119 participants
Primary outcome timeframe
Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Results posted on
2021-03-22
Participant Flow
Participant milestones
| Measure |
Placebo
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
24
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
22
|
24
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
69.0 years
n=99 Participants
|
60.7 years
n=107 Participants
|
63.8 years
n=206 Participants
|
60.0 years
n=7 Participants
|
59.3 years
n=31 Participants
|
62.4 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
38 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
81 Participants
n=30 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
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
119 Participants
n=30 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
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
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
|
0 Participants
n=30 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
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
45.8 Percentage of participants
Interval 25.6 to 67.2
|
68.0 Percentage of participants
Interval 46.5 to 85.1
|
80.0 Percentage of participants
Interval 59.3 to 93.2
|
SECONDARY outcome
Timeframe: 15 minutes after the start of study drug, if the OAA/S score is 5.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
|
5.1 Number of dosing
Standard Deviation 4.7
|
3.7 Number of dosing
Standard Deviation 3.4
|
1.9 Number of dosing
Standard Deviation 2.3
|
0.8 Number of dosing
Standard Deviation 1.5
|
0.5 Number of dosing
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 15 minutes after the start of study drug, if the OAA/S score is 5.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
|
1.019 mg/kg
Standard Deviation 0.933
|
0.744 mg/kg
Standard Deviation 0.675
|
0.373 mg/kg
Standard Deviation 0.459
|
0.166 mg/kg
Standard Deviation 0.298
|
0.096 mg/kg
Standard Deviation 0.231
|
SECONDARY outcome
Timeframe: During the study drug infusion period (≥15 minutes [Approximate])Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Time to First Rescue Administration of Propofol
|
25.5 minutes
Interval 20.0 to 46.0
|
20 minutes
Interval 20.0 to 22.0
|
24 minutes
Interval 21.0 to
The estimate dose not reach the point of 50%.
|
NA minutes
Interval 61.0 to
The estimate dose not reach the point of 50%.
|
NA minutes
The estimate dose not reach the point of 50%.
|
SECONDARY outcome
Timeframe: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
91.3 Percentage of participants
Interval 72.0 to 98.9
|
100.0 Percentage of participants
Interval 85.8 to 100.0
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
SECONDARY outcome
Timeframe: During the study drug administrationPopulation: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Number of Fentanyl Dosing Required During the Study Drug Administration.
|
0.1 Number of dosing
Standard Deviation 0.6
|
0.2 Number of dosing
Standard Deviation 0.7
|
0.0 Number of dosing
Standard Deviation 0.0
|
0.0 Number of dosing
Standard Deviation 0.2
|
0.1 Number of dosing
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: During the study drug administrationPopulation: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Dosage of Fentanyl Dosing Required During the Study Drug Administration.
|
0.068 mcg/kg
Standard Deviation 0.320
|
0.085 mcg/kg
Standard Deviation 0.317
|
0.000 mcg/kg
Standard Deviation 0.000
|
0.018 mcg/kg
Standard Deviation 0.088
|
0.061 mcg/kg
Standard Deviation 0.304
|
SECONDARY outcome
Timeframe: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion
|
50.17 Percentage of time
Standard Deviation 23.88
|
58.15 Percentage of time
Standard Deviation 20.71
|
61.44 Percentage of time
Standard Deviation 18.28
|
70.07 Percentage of time
Standard Deviation 21.08
|
76.78 Percentage of time
Standard Deviation 14.07
|
SECONDARY outcome
Timeframe: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion
|
47.88 Percentage of time
Standard Deviation 25.31
|
56 Percentage of time
Standard Deviation 19.87
|
53.66 Percentage of time
Standard Deviation 17.5
|
65.3 Percentage of time
Standard Deviation 20.63
|
62.25 Percentage of time
Standard Deviation 23.14
|
SECONDARY outcome
Timeframe: Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion
|
15 Minutes
There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).
|
15 Minutes
There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).
|
15 Minutes
Interval 15.0 to 16.0
|
15 Minutes
There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).
|
15 Minutes
There were a lot of tied values of the median in individual data, the 95% CI could not be calculated (could not become an interval).
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administrationPopulation: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)
|
5.85 Scores on a scale
Standard Deviation 3.54
|
4.36 Scores on a scale
Standard Deviation 3.41
|
3.73 Scores on a scale
Standard Deviation 3.19
|
2.81 Scores on a scale
Standard Deviation 2.64
|
2.65 Scores on a scale
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administrationPopulation: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)
|
2.05 Scores on a scale
Standard Deviation 2.21
|
3.3 Scores on a scale
Standard Deviation 3.19
|
1.68 Scores on a scale
Standard Deviation 1.46
|
1.72 Scores on a scale
Standard Deviation 2.14
|
1.47 Scores on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administrationPopulation: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)
|
2.35 Scores on a scale
Standard Deviation 2.77
|
2.62 Scores on a scale
Standard Deviation 2.79
|
1.8 Scores on a scale
Standard Deviation 2.02
|
2.85 Scores on a scale
Standard Deviation 2.9
|
3.12 Scores on a scale
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administrationPopulation: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)
|
1.48 Scores on a scale
Standard Deviation 1.67
|
1.8 Scores on a scale
Standard Deviation 2.35
|
1.05 Scores on a scale
Standard Deviation 1.46
|
1.15 Scores on a scale
Standard Deviation 1.19
|
1.17 Scores on a scale
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administration (as much as possible)Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")
|
1.7 Scores on a scale
Standard Deviation 0.8
|
1.7 Scores on a scale
Standard Deviation 1
|
1.2 Scores on a scale
Standard Deviation 0.4
|
1.4 Scores on a scale
Standard Deviation 0.7
|
1.3 Scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administration (as much as possible)Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")
|
1.2 Scores on a scale
Standard Deviation 0.7
|
1.2 Scores on a scale
Standard Deviation 0.7
|
1.2 Scores on a scale
Standard Deviation 0.7
|
1.4 Scores on a scale
Standard Deviation 0.9
|
1.2 Scores on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administration (as much as possible)Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")
|
1.7 Scores on a scale
Standard Deviation 1.1
|
1.5 Scores on a scale
Standard Deviation 0.8
|
1.3 Scores on a scale
Standard Deviation 0.6
|
1.5 Scores on a scale
Standard Deviation 0.8
|
1.2 Scores on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administration (as much as possible)Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")
|
2.2 Scores on a scale
Standard Deviation 1.3
|
2.2 Scores on a scale
Standard Deviation 1.3
|
2.2 Scores on a scale
Standard Deviation 1.2
|
1.8 Scores on a scale
Standard Deviation 1
|
2 Scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administration (as much as possible)Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")
|
1.6 Scores on a scale
Standard Deviation 1.1
|
1.6 Scores on a scale
Standard Deviation 0.8
|
1.6 Scores on a scale
Standard Deviation 0.9
|
1.4 Scores on a scale
Standard Deviation 0.9
|
1.7 Scores on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Within 24 hours after completion of the study drug administration (as much as possible)Population: Full Analysis Set\<FAS\>: FAS is defined as all patients who were administered with the study drugs.
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Outcome measures
| Measure |
Placebo
n=22 Participants
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 Participants
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 Participants
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 Participants
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 Participants
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")
|
1.6 Scores on a scale
Standard Deviation 0.9
|
1.6 Scores on a scale
Standard Deviation 1
|
1.6 Scores on a scale
Standard Deviation 0.6
|
1.3 Scores on a scale
Standard Deviation 0.7
|
1.5 Scores on a scale
Standard Deviation 1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Dexmedetomidine 0.067 mcg/kg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Dexmedetomidine 0.25 mcg/kg
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Dexmedetomidine 0.5 mcg/kg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Dexmedetomidine 1.0 mcg/kg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 participants at risk
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 participants at risk
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 participants at risk
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 participants at risk
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
0 mcg/kg/hr 10min Initial dose + 0 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.067 mcg/kg
n=23 participants at risk
0.4 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.25 mcg/kg
n=24 participants at risk
1.5 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 0.5 mcg/kg
n=25 participants at risk
3 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
Dexmedetomidine 1.0 mcg/kg
n=25 participants at risk
6 mcg/kg/hr 10min Initial dose + 0.2-0.7 mcg/kg/hr Maintenance dose
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Nervous system disorders
Headaches
|
9.1%
2/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Cardiac disorders
Bradycardia
|
36.4%
8/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
47.8%
11/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
37.5%
9/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
40.0%
10/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
44.0%
11/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
13.0%
3/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Vascular disorders
Vasculitides
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Vascular disorders
Hypertension
|
22.7%
5/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.7%
2/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.3%
2/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
12.0%
3/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
32.0%
8/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Vascular disorders
Hypotension
|
22.7%
5/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
52.2%
12/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
45.8%
11/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
32.0%
8/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
40.0%
10/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
54.5%
12/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
47.8%
11/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
50.0%
12/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
40.0%
10/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
44.0%
11/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
4/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
13.0%
3/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.3%
2/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
12.0%
3/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
12.0%
3/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Gastrointestinal disorders
Glossoptosis
|
13.6%
3/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.0%
2/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.0%
2/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Skin and subcutaneous tissue disorders
Erythemas
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.0%
2/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.3%
2/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
8.0%
2/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
General disorders
Chills
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
General disorders
Thirst
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
General disorders
Puncture site pain
|
9.1%
2/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
General disorders
Pyrexia
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.3%
1/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
General disorders
Pain
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.0%
1/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Investigations
Oxygen saturation decreased
|
4.5%
1/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/22 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/23 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
4.2%
1/24 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
0.00%
0/25 • Adverse events that occurred from the start of treatment to 24 hours after the end of treatment, a median of 67 - 87 mins treatment depending on treatment arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator publishes any results of this study, a pre-publication manuscript shall be provided the sponsor for review at least 60 days prior to the submission of the manuscript to the publisher.
- Publication restrictions are in place
Restriction type: OTHER