Trial Outcomes & Findings for Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation (NCT NCT05470465)
NCT ID: NCT05470465
Last Updated: 2025-05-22
Results Overview
Comparison of escitalopram or paroxetine with oxycodone to oxycodone alone. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 21.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
5 hours on day 21
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
Treatment Sequence ABC
Participants first received treatment A and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
|
Treatment ACB
Participants first received treatment A and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
|
Treatment BAC
Participants first received treatment B and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
|
Treatment BCA
Participants first received treatment B and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
|
Treatment CAB
Participants first received treatment C and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
|
Treatment CBA
Participants first received treatment C and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
2
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation
Baseline characteristics by cohort
| Measure |
Total
n=27 Participants
Participants received a treatment in a randomized order and then crossed over to the sequential treatments with three weeks of washout in between treatments.
Treatments are as follows:
Treatment A (Placebo and Oxycodone): Participants receive placebo on days 1-21 and Oxycodone 10 mg (2 x 5 mg tablets) on days 6, 12, and 21 of this treatment period.
Treatment B (Paroxetine and Oxycodone): Participants receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
Treatment C (Escitalopram and Oxycodone): Participants receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) is administered on days 6, 12, and 21 of this treatment period.
|
|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Body Weight
|
77 kg
n=93 Participants
|
|
Body Mass Index
|
24.4 kg/m2
n=93 Participants
|
|
Minute Ventilation
|
9.4 L/min
n=93 Participants
|
|
Respiratory Rate
|
13.6 breaths/min
n=93 Participants
|
|
Tidal Volume
|
0.79 L
n=93 Participants
|
|
End-tidal Carbon Dioxide
|
36.0 mmHg
n=93 Participants
|
|
Oxygen Saturation
|
96.8 percentage
n=93 Participants
|
|
Age, Continuous
|
36 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 hours on day 21Comparison of escitalopram or paroxetine with oxycodone to oxycodone alone. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 21.
Outcome measures
| Measure |
Paroxetine + Oxycodone
n=22 Participants
Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Escitalopram + Oxycodone
n=22 Participants
Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Placebo + Oxycodone
n=22 Participants
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
Minute Ventilation at 55mm Hg End Tidal CO2 (VE55) Under Hyperoxic Conditions on Day 21
|
20.2 L/min
Interval 15.8 to 24.6
|
21.2 L/min
Interval 16.8 to 25.6
|
26.7 L/min
Interval 22.3 to 31.2
|
PRIMARY outcome
Timeframe: 5 hours on day 20Comparison of escitalopram or paroxetine to placebo. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 20.
Outcome measures
| Measure |
Paroxetine + Oxycodone
n=22 Participants
Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Escitalopram + Oxycodone
n=22 Participants
Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Placebo + Oxycodone
n=22 Participants
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
VE55 Under Hyperoxic Conditions on Day 20
|
30.8 L/min
Interval 25.9 to 35.7
|
30.4 L/min
Interval 25.5 to 35.3
|
37.4 L/min
Interval 32.4 to 42.3
|
SECONDARY outcome
Timeframe: 5 hours on day 6Comparison of escitalopram or paroxetine with oxycodone to oxycodone alone. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 6.
Outcome measures
| Measure |
Paroxetine + Oxycodone
n=22 Participants
Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Escitalopram + Oxycodone
n=22 Participants
Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Placebo + Oxycodone
n=22 Participants
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
VE55 Under Hyperoxic Conditions on Day 6
|
18.5 L/min
Interval 14.8 to 22.2
|
20.0 L/min
Interval 16.4 to 23.7
|
25.6 L/min
Interval 21.8 to 29.4
|
SECONDARY outcome
Timeframe: 5 hours on day 12Comparison of escitalopram or paroxetine with oxycodone to oxycodone alone. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 12.
Outcome measures
| Measure |
Paroxetine + Oxycodone
n=22 Participants
Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Escitalopram + Oxycodone
n=22 Participants
Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Placebo + Oxycodone
n=22 Participants
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
VE55 Under Hyperoxic Conditions on Day 12
|
18.1 L/min
Interval 14.0 to 22.3
|
21.4 L/min
Interval 17.3 to 25.5
|
28.2 L/min
Interval 24.0 to 32.4
|
SECONDARY outcome
Timeframe: 5 hours on day 5Comparison of escitalopram or paroxetine to placebo. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 5.
Outcome measures
| Measure |
Paroxetine + Oxycodone
n=22 Participants
Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Escitalopram + Oxycodone
n=22 Participants
Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Placebo + Oxycodone
n=22 Participants
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
VE55 Under Hyperoxic Conditions on Day 5
|
31.1 L/min
Interval 26.8 to 35.4
|
28.6 L/min
Interval 24.3 to 32.9
|
42.6 L/min
Interval 38.3 to 46.9
|
SECONDARY outcome
Timeframe: 5 hours on day 11Comparison of escitalopram or paroxetine to placebo. Rebreathing data will be analyzed by regression of the minute ventilation versus partial pressure of end tidal CO2 (PETCO2) data to estimate VE55. Resulting VE55 data will be compared using a linear mixed effects model. Comparison will be at 5 hours on day 11.
Outcome measures
| Measure |
Paroxetine + Oxycodone
n=22 Participants
Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Escitalopram + Oxycodone
n=22 Participants
Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Placebo + Oxycodone
n=22 Participants
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
VE55 Under Hyperoxic Conditions on Day 11
|
27.3 L/min
Interval 21.8 to 32.9
|
32.0 L/min
Interval 26.4 to 37.5
|
41.4 L/min
Interval 35.8 to 47.0
|
Adverse Events
Treatment A: Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Treatment B: Paroxetine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Treatment C: Escitalopram
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: Placebo
n=27 participants at risk
Participants will receive placebo on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Placebo and Oxycodone: Participants will receive placebo on days 1-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Treatment B: Paroxetine
n=27 participants at risk
Participants will receive paroxetine on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Paroxetine and Oxycodone: Participants will receive 40 mg paroxetine (2 x 20 mg tablets) on days 1-6 and 60 mg paroxetine (3 x 20 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
Treatment C: Escitalopram
n=27 participants at risk
Participants will receive escitalopram on days 1-21 for this treatment period. Oxycodone will be administered on days 6, 12, and 21 of this treatment period.
Escitalopram and Oxycodone: Participants will receive 20 mg escitalopram (2 x 10 mg tablets) on days 1-6 and 30 mg escitalopram (3 x 10 mg tablets) on days 7-21 for this treatment period. Oxycodone 10 mg (2 x 5 mg tablets) will be administered on days 6, 12, and 21 of this treatment period.
|
|---|---|---|---|
|
General disorders
Hot Flush
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Hyperacusis
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Infections and infestations
COVID-19
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Gastrointestinal disorders
Nausea
|
22.2%
6/27 • Number of events 13 • 106 days
|
14.8%
4/27 • Number of events 4 • 106 days
|
22.2%
6/27 • Number of events 6 • 106 days
|
|
Nervous system disorders
Dizziness
|
18.5%
5/27 • Number of events 5 • 106 days
|
14.8%
4/27 • Number of events 4 • 106 days
|
11.1%
3/27 • Number of events 3 • 106 days
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
1/27 • Number of events 1 • 106 days
|
25.9%
7/27 • Number of events 7 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 3 • 106 days
|
14.8%
4/27 • Number of events 4 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Drowsiness
|
14.8%
4/27 • Number of events 4 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
|
General disorders
Application site irritation
|
11.1%
3/27 • Number of events 3 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
|
Nervous system disorders
Insomnia
|
3.7%
1/27 • Number of events 1 • 106 days
|
14.8%
4/27 • Number of events 4 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Infusion site bruising
|
7.4%
2/27 • Number of events 3 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Contusion
|
7.4%
2/27 • Number of events 2 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Brain fog
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 1 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
General disorders
Fatigue
|
7.4%
2/27 • Number of events 2 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Vision blurred
|
3.7%
1/27 • Number of events 1 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Vessel puncture site bruise
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.4%
2/27 • Number of events 2 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Vessel puncture site erythema
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
7.4%
2/27 • Number of events 3 • 106 days
|
|
Eye disorders
Dry eye
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
7.4%
2/27 • Number of events 3 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
General disorders
Infusion site pain
|
7.4%
2/27 • Number of events 2 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
7.4%
2/27 • Number of events 2 • 106 days
|
|
Gastrointestinal disorders
Change in bowel habit
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
General disorders
Vessel puncture site pain
|
3.7%
1/27 • Number of events 2 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
General disorders
Infusion site erythema
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Tremor
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Nervous system disorders
Presyncope
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Psychiatric disorders
Anorgasmia
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.4%
2/27 • Number of events 2 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.7%
1/27 • Number of events 1 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.7%
1/27 • Number of events 2 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Renal and urinary disorders
Urinary hesitation
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
General disorders
Feeling jittery
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Psychiatric disorders
Sleep talking
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Paroncychia
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Skin laceration
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
General disorders
Chills
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Ear and labyrinth disorders
Ear pain
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Cardiac disorders
Palpitations
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Skin and subcutaneous tissue disorders
Burns first degree
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Cardiac disorders
Tachycardia
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Pruritis
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
0.00%
0/27 • 106 days
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
General disorders
Irritability
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/27 • 106 days
|
3.7%
1/27 • Number of events 1 • 106 days
|
0.00%
0/27 • 106 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place