Trial Outcomes & Findings for A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers (NCT NCT01989455)
NCT ID: NCT01989455
Last Updated: 2014-12-23
Results Overview
Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
14-hour interval
Results posted on
2014-12-23
Participant Flow
Participant milestones
| Measure |
500 mg Deferiprone
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
|
1500 mg Deferiprone
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
8
|
|
Overall Study
COMPLETED
|
14
|
12
|
13
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
500 mg Deferiprone
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
|
1500 mg Deferiprone
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Technical problems with infusion
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
n=8 Participants
Single intravenous dose of placebo (normal saline solution).
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
43 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
54 Participants
n=8 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
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
14 participants
n=4 Participants
|
8 participants
n=21 Participants
|
64 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 14-hour intervalCmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax for serum deferiprone
|
7.406 μg/mL
Standard Deviation 1.889
|
17.835 μg/mL
Standard Deviation 2.162
|
27.749 μg/mL
Standard Deviation 2.768
|
36.644 μg/mL
Standard Deviation 6.643
|
—
|
|
Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Cmax for serum deferiprone-3-O-glucuronide
|
8.037 μg/mL
Standard Deviation 1.374
|
16.490 μg/mL
Standard Deviation 4.348
|
20.032 μg/mL
Standard Deviation 3.757
|
30.517 μg/mL
Standard Deviation 3.947
|
—
|
PRIMARY outcome
Timeframe: 14-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose. The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation).
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Tmax for Serum Deferiprone
|
1.00 hour
Interval 1.0 to 1.33
|
1.00 hour
Interval 0.75 to 1.07
|
1.00 hour
Interval 1.0 to 1.0
|
1.00 hour
Interval 1.0 to 1.0
|
—
|
|
Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide
Tmax for Serum Deferiprone 3-O-glucuronide
|
2.50 hour
Interval 1.67 to 3.0
|
2.50 hour
Interval 1.67 to 3.0
|
2.50 hour
Interval 2.0 to 3.0
|
2.50 hour
Interval 1.67 to 3.0
|
—
|
PRIMARY outcome
Timeframe: 14-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ for serum deferiprone
|
18.326 μg*h/mL
Standard Deviation 4.115
|
41.805 μg*h/mL
Standard Deviation 6.797
|
69.390 μg*h/mL
Standard Deviation 8.937
|
89.250 μg*h/mL
Standard Deviation 17.223
|
—
|
|
Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide
AUC0-∞ for serum deferiprone 3-O-glucuronide
|
38.504 μg*h/mL
Standard Deviation 8.011
|
79.210 μg*h/mL
Standard Deviation 15.686
|
105.829 μg*h/mL
Standard Deviation 13.052
|
161.507 μg*h/mL
Standard Deviation 16.876
|
—
|
PRIMARY outcome
Timeframe: 14-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2el for serum deferiprone
|
1.68 hour
Standard Deviation 0.22
|
1.77 hour
Standard Deviation 0.32
|
1.83 hour
Standard Deviation 0.22
|
1.85 hour
Standard Deviation 0.17
|
—
|
|
The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide
T1/2el for serum deferiprone 3-O-glucuronide
|
2.00 hour
Standard Deviation 0.25
|
1.94 hour
Standard Deviation 0.25
|
2.01 hour
Standard Deviation 0.18
|
1.94 hour
Standard Deviation 0.26
|
—
|
PRIMARY outcome
Timeframe: From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferipronePopulation: The safety population included all subjects who received study product.
The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
n=8 Participants
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.
|
10 participants
|
7 participants
|
8 participants
|
10 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 14-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=12 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone
Cmax for serum deferiprone
|
17.835 μg/mL
Standard Deviation 2.162
|
11.692 μg/mL
Standard Deviation 3.436
|
—
|
—
|
—
|
|
Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone
Cmax for serum deferiprone-3-O-glucuronide
|
16.490 μg/mL
Standard Deviation 4.348
|
18.806 μg/mL
Standard Deviation 5.659
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14-hour intervalPopulation: The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.
The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=13 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=12 Participants
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Absolute Bioavailability of Deferiprone
|
41.805 μg*h/mL
Standard Deviation 6.797
|
30.796 μg*h/mL
Standard Deviation 7.182
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From dosing until 24 hours post-dosePopulation: The safety population included all subjects who received study product.
The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.
Outcome measures
| Measure |
500 mg Deferiprone for Infusion
n=14 Participants
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
Single intravenous dose of placebo (normal saline solution).
|
|---|---|---|---|---|---|
|
Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone
|
2 participants
|
—
|
—
|
—
|
—
|
Adverse Events
500 mg Deferiprone for Infusion
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
1000 mg Deferiprone for Infusion
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1500 mg Deferiprone for Infusion
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
2000 mg Deferiprone for Infusion
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1000 mg Oral Deferiprone
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 |
500 mg Deferiprone for Infusion
n=14 participants at risk
Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1000 mg Deferiprone for Infusion
n=14 participants at risk
Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
1500 mg Deferiprone for Infusion
n=14 participants at risk
Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
2000 mg Deferiprone for Infusion
n=14 participants at risk
Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
|
Placebo
n=8 participants at risk
Single intravenous dose of placebo (normal saline solution).
|
1000 mg Oral Deferiprone
n=14 participants at risk
Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
57.1%
8/14 • Number of events 9
|
35.7%
5/14 • Number of events 5
|
28.6%
4/14 • Number of events 4
|
35.7%
5/14 • Number of events 5
|
0.00%
0/8
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • Number of events 4
|
28.6%
4/14 • Number of events 4
|
21.4%
3/14 • Number of events 3
|
28.6%
4/14 • Number of events 5
|
0.00%
0/8
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Nervous system disorders
Vertigo
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
0.00%
0/8
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
12.5%
1/8 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
12.5%
1/8 • Number of events 1
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 2
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
General disorders
Feeling hot
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Catheter site swelling
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Vessel puncture site pain
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Vessel puncture site reaction
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Catheter site pain
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
12.5%
1/8 • Number of events 1
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14
|
0.00%
0/14
|
14.3%
2/14 • Number of events 2
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Generalized erythema
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
0.00%
0/14
|
|
Investigations
C-reactive protein increased
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/8
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/8
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60