Trial Outcomes & Findings for Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests (NCT NCT01189604)
NCT ID: NCT01189604
Last Updated: 2011-12-19
Results Overview
The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
2 minutes from the beginning of the maintenance period
Results posted on
2011-12-19
Participant Flow
A total of 2 centers were initiated with first patient enrolled on 23 August 2010 and last patient completed on 17 November. A total of 129 patients were enrolled with 123 qualified patients allocated to randomized treatment.
The patients enrolled in this study were undergoing non-emergent standard esophagogastroduodenoscopy (EGD) or colonoscopy. Six patients were withdrawn from the study after enrollment but before randomization: 5 patients due to excess recruitment and one patient due to investigator's recommendation..
Participant milestones
| Measure |
Arm 1 - Placebo
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
20
|
20
|
20
|
11
|
10
|
|
Overall Study
Administered Study Drug
|
20
|
20
|
20
|
20
|
20
|
10
|
10
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
18
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 - Placebo
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Impossible to visit
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Baseline characteristics by cohort
| Measure |
Arm 1 - Placebo
n=20 Participants
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
53.2 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 16.4 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 14.9 • n=4 Participants
|
56.4 years
STANDARD_DEVIATION 12.7 • n=21 Participants
|
49.4 years
STANDARD_DEVIATION 14.2 • n=8 Participants
|
51.8 years
STANDARD_DEVIATION 8.5 • n=8 Participants
|
53.2 years
STANDARD_DEVIATION 14.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
48 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
72 Participants
n=24 Participants
|
|
Procedures
Esophagogastroduodenoscopy (EGD)
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
5 participants
n=8 Participants
|
5 participants
n=8 Participants
|
60 participants
n=24 Participants
|
|
Procedures
Colonoscopy
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
5 participants
n=8 Participants
|
5 participants
n=8 Participants
|
60 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 2 minutes from the beginning of the maintenance periodThe MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Outcome measures
| Measure |
Arm 1 - Placebo
n=20 Participants
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
MOAA/S Score 0-1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
MOAA/S Score 2-4
|
0 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
14 Participants
|
5 Participants
|
3 Participants
|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
MOAA/S Score 5
|
20 Participants
|
18 Participants
|
14 Participants
|
13 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 4 minutes from the beginning of the maintenance periodThe MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Outcome measures
| Measure |
Arm 1 - Placebo
n=20 Participants
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
MOAA/S Score 0-1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
MOAA/S Score 2-4
|
0 Participants
|
1 Participants
|
7 Participants
|
6 Participants
|
16 Participants
|
5 Participants
|
4 Participants
|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
MOAA/S Score 5
|
20 Participants
|
19 Participants
|
13 Participants
|
13 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 24 - 48 hours after completion of the procedureThe PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied).
Outcome measures
| Measure |
Arm 1 - Placebo
n=20 Participants
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire
|
62.5 Units on a scale
Standard Deviation 21.2
|
64.4 Units on a scale
Standard Deviation 23.8
|
74.5 Units on a scale
Standard Deviation 17.1
|
82.3 Units on a scale
Standard Deviation 17.9
|
86.0 Units on a scale
Standard Deviation 9.8
|
74.9 Units on a scale
Standard Deviation 16.2
|
75.1 Units on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: At the end of the initiation period and every 2 minutes during the maintenance periodBlood concentration of ICI35,868 (propofol)
Outcome measures
| Measure |
Arm 1 - Placebo
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=6 Participants
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=6 Participants
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=6 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=6 Participants
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=4 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=4 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Blood Concentrations of Propofol
End of initiation period
|
—
|
0.2208 µg/mL
Standard Deviation 0.1409
|
0.7808 µg/mL
Standard Deviation 0.3765
|
1.5033 µg/mL
Standard Deviation 0.9468
|
2.3177 µg/mL
Standard Deviation 1.2459
|
1.1935 µg/mL
Standard Deviation 1.0758
|
1.0875 µg/mL
Standard Deviation 0.7553
|
|
Blood Concentrations of Propofol
2 minutes into maintenance period
|
—
|
0.2797 µg/mL
Standard Deviation 0.1320
|
0.6403 µg/mL
Standard Deviation 0.3087
|
1.1052 µg/mL
Standard Deviation 0.7197
|
2.1827 µg/mL
Standard Deviation 0.7832
|
1.3965 µg/mL
Standard Deviation 0.7796
|
0.8515 µg/mL
Standard Deviation 0.6399
|
|
Blood Concentrations of Propofol
4 minutes into maintenance period
|
—
|
0.3295 µg/mL
Standard Deviation 0.1474
|
0.7387 µg/mL
Standard Deviation 0.3000
|
1.2022 µg/mL
Standard Deviation 0.5612
|
2.4360 µg/mL
Standard Deviation 0.8500
|
1.4828 µg/mL
Standard Deviation 0.4286
|
1.0708 µg/mL
Standard Deviation 0.7864
|
|
Blood Concentrations of Propofol
6 minutes into maintenance period
|
—
|
0.3633 µg/mL
Standard Deviation 0.2340
|
0.8127 µg/mL
Standard Deviation 0.2716
|
1.4263 µg/mL
Standard Deviation 0.6700
|
2.4714 µg/mL
Standard Deviation 0.3901
|
1.4848 µg/mL
Standard Deviation 0.4056
|
1.0560 µg/mL
Standard Deviation 0.7915
|
SECONDARY outcome
Timeframe: Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus \[trapezius squeeze\]) to 5 (Responds readily to name spoken in normal tone \[awake\]). MOAA/S scores were classified as 0-1, 2-4 and 5.
Outcome measures
| Measure |
Arm 1 - Placebo
n=20 Participants
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=20 Participants
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=10 Participants
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
MOAA/S Score 0-1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
MOAA/S Score 2-4
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
|
Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
MOAA/S Score 5
|
20 Participants
|
18 Participants
|
20 Participants
|
16 Participants
|
10 Participants
|
10 Participants
|
9 Participants
|
Adverse Events
Arm 1 - Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 2 - ICI35,868 (Propofol)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3 - ICI35,868 (Propofol)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4 - ICI35,868 (Propofol)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 5 - ICI35,868 (Propofol)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Arm 6 - ICI35,868 (Propofol)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 7 - ICI35,868 (Propofol)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - Placebo
n=20 participants at risk
Infusion of placebo, same infusion rates as for arm 2
|
Arm 2 - ICI35,868 (Propofol)
n=20 participants at risk
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
|
Arm 3 - ICI35,868 (Propofol)
n=20 participants at risk
Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
|
Arm 4 - ICI35,868 (Propofol)
n=20 participants at risk
Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 5 - ICI35,868 (Propofol)
n=20 participants at risk
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
|
Arm 6 - ICI35,868 (Propofol)
n=10 participants at risk
Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
|
Arm 7 - ICI35,868 (Propofol)
n=10 participants at risk
Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/10
|
10.0%
1/10
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/10
|
10.0%
1/10
|
|
Investigations
Blood Pressure Increased
|
20.0%
4/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
Heart Rate Increased
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
10.0%
1/10
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
5.0%
1/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
5.0%
1/20
|
0.00%
0/10
|
0.00%
0/10
|
|
Vascular disorders
Angiopathy
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
0.00%
0/20
|
10.0%
2/20
|
0.00%
0/10
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the PI wants to publish the results, the PI must send the English documents to AZ beforehand. And AZ can review and revise the documents, after that, AZ will give the approval to the PI about the publication of the results.
- Publication restrictions are in place
Restriction type: OTHER